This page shows what was measured, who it was measured in, and what that does not settle.
What Dalteparin does in the body
Preventing or treating blood clots, including long-term treatment in people with cancer.
Your blood carries its own brake on clotting, a protein called antithrombin, which works slowly by itself. Dalteparin is heparin that has been chopped into shorter chains using nitrous acid, and those chains latch onto antithrombin and force it into a shape that destroys the clotting enzyme factor Xa far faster. Because the chains are short, they mostly cannot reach thrombin as well, so the drug acts a step upstream. The dose is fixed by body weight, absorption is nearly complete, and no routine blood test is needed.
What happened in people
In people with cancer, repeat clots fell from about 16 in 100 to 8 without increasing serious bleeding.
✓ Reviewed first-read answer
Where this came from
A person wrote this and a reviewer approved it against this exact record. It carries no effect size.
A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.
No source is stored against this line.
The limit that matters most
A separate study found no clear improvement in cancer survival.
Where it acts
Blood plasma, at the antithrombin III molecule circulating there — no cell is entered at any point
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as polymer.
FDA substance registry · S79O08V79F · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 120 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Recurrent symptomatic venous thromboembolism over six months, dalteparin monotherapy versus dalteparin followed by a coumarin, in patients with cancer
27/336 vs 53/336, hazard ratio 0.48, p=0.002; six-month recurrence probability 9% vs 17%
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Six-month mortality was 39% and 41% — this is a population in which the competing risk of death from cancer dwarfs the endpoint being measured. Major bleeding was numerically higher on dalteparin, 6% against 4%, though not significantly so. Open-label design.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous injection, once daily in most indications
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Fragmin during Instability in Coronary Artery Disease (FRISC) Study Group. Low-molecular-weight heparin during instability in coronary artery disease. Lancet… · a recorded source, not a stored snapshot
Survival at one year in patients with advanced malignancy, dalteparin 5,000 IU daily versus placebo
One-, two- and three-year survival 46%, 27% and 21% on dalteparin against 41%, 18% and 12% on placebo, p=0.19 — not met
Repeated elsewhere
Failed to Replicate
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. The widely cited positive result comes from an analysis the publication describes as "not specified a priori", restricted to 102 patients selected for being alive 17 months after randomisation — a selection on a post-randomisation event that breaks the randomisation it relies on.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous injection, once daily in most indications
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Fragmin during Instability in Coronary Artery Disease (FRISC) Study Group. Low-molecular-weight heparin during instability in coronary artery disease. Lancet… · a recorded source, not a stored snapshot
Proximal leg deep vein thrombosis on protocol compression ultrasonography, dalteparin 5,000 IU daily versus unfractionated heparin 5,000 IU twice daily
✗ The study did not show it
Who was studied
PROTECT (NCT00182143)
How many people
3764
Study design
Phase 3 randomised double-blind superiority trial in intensive care
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
5.1% (96/1873) vs 5.8% (109/1873), hazard ratio 0.92 (95% CI 0.68 to 1.23), p=0.57 — superiority not demonstrated
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Pulmonary embolism, a secondary endpoint, was lower on dalteparin (1.3% vs 2.3%, p=0.01) and is the result most often quoted from this trial. Major bleeding and in-hospital death did not differ.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous injection, once daily in most indications
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Fragmin during Instability in Coronary Artery Disease (FRISC) Study Group. Low-molecular-weight heparin during instability in coronary artery disease. Lancet… · a recorded source, not a stored snapshot
Death or new myocardial infarction during the first six days, dalteparin plus aspirin versus placebo plus aspirin in unstable coronary artery disease
13 (1.8%) vs 36 (4.8%), risk ratio 0.37 (95% CI 0.20 to 0.68). Composite endpoint 5.4% vs 10.3%, risk ratio 0.52 (0.37 to 0.75)
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. At 4 to 5 months after treatment ended there were no significant differences in death, myocardial infarction or revascularisation. Subgroup analysis found the 40-day effect confined to non-smokers, and reactivation on dose reduction was more pronounced in smokers.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous injection, once daily in most indications
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Fragmin during Instability in Coronary Artery Disease (FRISC) Study Group. Low-molecular-weight heparin during instability in coronary artery disease. Lancet… · a recorded source, not a stored snapshot
Composite of recurrent venous thromboembolism or major bleeding at 12 months, edoxaban versus dalteparin in cancer-associated thrombosis
✓ The study showed what it set out to show
Who was studied
Hokusai VTE Cancer (NCT02073682)
How many people
1046
Study design
Phase 3 randomised open-label non-inferiority trial, up to 12 months
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
12.8% edoxaban vs 13.5% dalteparin, hazard ratio 0.97 (95% CI 0.70 to 1.36), p=0.006 for non-inferiority
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Dalteparin had more recurrent clots (11.3% vs 7.9%) and less major bleeding (4.0% vs 6.9%). The composite recorded a tie because the two components moved in opposite directions.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous injection, once daily in most indications
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Fragmin during Instability in Coronary Artery Disease (FRISC) Study Group. Low-molecular-weight heparin during instability in coronary artery disease. Lancet… · a recorded source, not a stored snapshot
What we know
RNAWiki holds 5 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Dalteparin
What a person takes: Subcutaneous injection, once daily in most indications.
The measurement behind this step
Preservative-free single-dose prefilled syringes with a needle-guard device, in seven strengths from 2,500 to 18,000 anti-factor Xa units, plus single-dose and multiple-dose vials. The multiple-dose vials contain benzyl alcohol as a preservative, which the prefilled syringes do not. Absolute bioavailability is 87 ± 6% and peak anti-factor Xa activity occurs about four hours after injection. No routine coagulation monitoring is required, and the routine coagulation screen would not show anything if it were performed.
Getting in
A once-daily injection, dosed in activity units not milligrams
Injected under the skin once a day. The dose is written in units of clotting-blocking activity rather than in milligrams, because the drug is a mixture and its weight says little about its strength.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Supplied in prefilled syringes from 2,500 to 18,000 anti-factor Xa international units, referenced to the WHO First International Low Molecular Weight Heparin Reference Standard, and in multiple-dose vials at 25,000 units per mL. Absolute subcutaneous bioavailability by anti-factor Xa activity is 87 ± 6%, with peak activity at about 4 hours.
It finds antithrombin already circulating in the blood
It never enters a cell. It works entirely in the bloodstream, by binding a protein that is already there and speeding it up.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
A polydisperse mixture of sulfated polysaccharide chains, average molecular weight about 5,000 daltons with roughly 90% between 2,000 and 9,000. Only the chains carrying the specific antithrombin-binding pentasaccharide are active; the remainder is pharmacologically inert. No receptor, no cellular uptake, no intracellular target.
Once bound, antithrombin snaps into an active shape and destroys the clotting enzyme factor Xa at a vastly higher rate than it would alone.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The pentasaccharide induces a conformational change that expels antithrombin’s reactive centre loop, converting a slow substrate-like inhibitor into a rapid one. Dalteparin dissociates intact afterwards and binds another antithrombin molecule — it is catalytic, not consumed.
Longer chains can also block the final clotting enzyme; short ones cannot. This mixture sits slightly further towards the long end than enoxaparin does.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Bridging antithrombin and thrombin needs roughly 18 saccharide units. With an average of 5,000 daltons and 14 to 26% of material above 8,000, dalteparin retains proportionally more anti-thrombin activity than enoxaparin, whose average is about 4,500 daltons. The label states this as a preference rather than a ratio: preferential potentiation of factor Xa inhibition, with only slight effect on the activated partial thromboplastin time.
Fewer recurrent clots in cancer, at unchanged bleeding
Over six months in cancer patients, about half as many clots came back compared with warfarin-type tablets, and serious bleeding did not rise.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
CLOT: recurrent venous thromboembolism 8.0% against 15.8% at six months, hazard ratio 0.48, p=0.002, with major bleeding 6% against 4% (not significant) and six-month mortality 39% against 41%. Clearance is predominantly renal, so exposure rises as kidney function falls. Protamine neutralises the anti-thrombin activity but reverses the anti-factor Xa activity only partially.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults with cancer being treated for a clot in a leg or lung, surgical and medical inpatients at risk of clots, and patients with unstable angina or non-Q-wave myocardial infarction alongside aspirin.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of FRAGMIN for the treatment of symptomatic venous thromboembolism (VTE) in patients have been established in pediatric patients from birth (gestational age at least 35 weeks) to less than 17 years of age.”
US prescribing information · 23527b8b-9b28-4e6d-9751-33b143975ac7 · read 2026-08-30
On older people, the label states: “Of the total number of patients in clinical studies of FRAGMIN, 5,516 patients were 65 years of age or older and 2,237 were 75 or older.”
US prescribing information · 23527b8b-9b28-4e6d-9751-33b143975ac7 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available data from published literature and postmarketing reports have not reported a clear association with FRAGMIN and adverse developmental outcomes.”
US prescribing information · 23527b8b-9b28-4e6d-9751-33b143975ac7 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Limited published data indicate that dalteparin is present in human milk in small amounts (see Data ) .”
US prescribing information · 23527b8b-9b28-4e6d-9751-33b143975ac7 · read 2026-08-30
Where the result stopped carrying
The primary survival endpoint of FAMOUS, p=0.19
The primary endpoint of PROTECT, where dalteparin was not superior to unfractionated heparin for proximal deep vein thrombosis
The durability of the FRISC coronary benefit, gone within 4 to 5 months of stopping
Its monopoly in cancer-associated thrombosis, ended in 2018 by a head-to-head tie against an oral drug
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Subcutaneous injection, once daily in most indications
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S11, S1.
No source is stored against this line.
What is in the pack
Preservative-free single-dose prefilled syringes with a needle-guard device, in seven strengths from 2,500 to 18,000 anti-factor Xa units, plus single-dose and multiple-dose vials. The multiple-dose vials contain benzyl alcohol as a preservative, which the prefilled syringes do not. Absolute bioavailability is 87 ± 6% and peak anti-factor Xa activity occurs about four hours after injection. No routine coagulation monitoring is required, and the routine coagulation screen would not show anything if it were performed.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
The United States label carries the class boxed warning on spinal and epidural haematoma in patients receiving neuraxial anaesthesia or undergoing spinal puncture, which can cause long-term or permanent paralysis. Clearance is predominantly renal, so exposure and bleeding risk rise as kidney function falls. Heparin-induced thrombocytopenia occurs less often than with unfractionated heparin but is not absent — PROTECT found a hazard ratio of 0.27 in per-protocol analysis — and dalteparin is contraindicated once that diagnosis is established because the antibody cross-reacts. Protamine reverses the anti-thrombin activity but only partially reverses anti-factor Xa activity. Multiple-dose vials contain benzyl alcohol.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Subcutaneous injection, once daily in most indications
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
The multiple-dose vials contain benzyl alcohol as a preservative, which the prefilled syringes do not. Absolute bioavailability is 87 ± 6% and peak anti-factor Xa activity occurs about four hours after injection. No routine coagulation monitoring is required, and the routine coagulation screen would not show anything if it were performed.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
9 products list this as an active ingredient in the United States drug directory. 9 of them contain it and nothing else.
FDA National Drug Code directory · 0069-0253 · read 2026-08-29
They are sold as injection, taken subcutaneous.
FDA National Drug Code directory · 0069-0253 · read 2026-08-29
The regulator's established pharmacologic class for it is anti-coagulant [epc], heparin and low molecular weight heparin [epc].
FDA National Drug Code directory · 0069-0253 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 23527b8b-9b28-4e6d-9751-33b143975ac7 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 23527b8b-9b28-4e6d-9751-33b143975ac7 · read 2026-08-29
Fragmin is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS FRAGMIN (dalteparin sodium) injection is a sterile, aqueous, clear, colorless or straw-colored solution for injection, available in the following dosage forms and strengths: • Injection: 2,5…, recorded as fda label in effect 2025-09-30 in the United States.
US prescribing information · 23527b8b-9b28-4e6d-9751-33b143975ac7 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Dalteparin studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That dalteparin prolongs survival or modifies tumour biology in advanced cancer — the primary endpoint failed and the supporting analysis was unplanned, in a subgroup selected for having already survived 17 months
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That dalteparin prevents pulmonary embolism better than unfractionated heparin in intensive care — a secondary endpoint reported after the primary was missed
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the coronary benefit is durable — it was absent 4 to 5 months after treatment ended, and the 40-day effect was confined to non-smokers on subgroup analysis
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That dalteparin and enoxaparin are interchangeable — different depolymerisation chemistries, different chain-length distributions, and no head-to-head outcome trial
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Dalteparin are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
CLOT: recurrent clots in cancer patients halved against an oral anticoagulant
In plain words
In 672 people with cancer and a clot, six months of daily injections prevented about half the recurrences that warfarin-type tablets allowed, without causing more serious bleeding.
What was measured
Recurrent symptomatic venous thromboembolism over six months, 8.0% against 15.8%, and major bleeding 6% against 4%
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CLOT randomised patients with cancer and acute symptomatic proximal deep vein thrombosis, pulmonary embolism or both to dalteparin 200 IU/kg once daily for five to seven days followed by a coumarin for six months at a target international normalised ratio of 2.5, or to dalteparin alone for six months. Recurrent venous thromboembolism occurred in 27 of 336 dalteparin patients against 53 of 336 oral anticoagulant patients, hazard ratio 0.48, p=0.002; the six-month probability of recurrence was 9% against 17%. Major bleeding was 6% against 4% and any bleeding 14% against 19%, neither difference significant. Mortality at six months was 39% against 41% — a figure that describes the population rather than the treatment, and which is worth quoting because it puts the recurrence numbers in proportion. This trial made low molecular weight heparin the standard of care for cancer-associated thrombosis for the following fifteen years.
Written into the record, not signed off as a reviewed claim
FAMOUS missed its survival endpoint, and its famous subgroup was chosen after the fact
In plain words
A trial asked whether this drug helps people with advanced cancer live longer. It did not — survival at one year was no different. A second analysis, not planned in advance, looked only at patients who had already survived 17 months and reported a benefit.
What was measured
One-year survival in advanced malignancy, 46% against 41% on placebo, p=0.19 — primary endpoint not met
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
FAMOUS randomised 385 patients with advanced malignancy to dalteparin 5,000 IU once daily or placebo for one year, with survival at one year as the primary aim. Kaplan-Meier survival at 1, 2 and 3 years was 46%, 27% and 21% on dalteparin against 41%, 18% and 12% on placebo, p=0.19 — the primary endpoint was not met. The publication then reports, in its own words, "an analysis not specified a priori" restricted to a subgroup of patients "who had a better prognosis and who were alive 17 months after randomization" — 55 on dalteparin and 47 on placebo — in whom 2- and 3-year survival was 78% against 55% and 60% against 36%, p=0.03. Selecting a subgroup on the basis of having already survived a long time, after the primary analysis has failed, cannot support a causal claim: survivors are not a random sample of the randomised groups, and randomisation is destroyed the moment the selection is made on a post-randomisation event. The conclusion drawn — that the result "suggests a potential modifying effect of dalteparin on tumor biology" — is an inference several steps beyond what the design can carry, and it has been cited widely.
Written into the record, not signed off as a reviewed claim
PROTECT: the primary endpoint missed in 3,764 intensive care patients
In plain words
The largest trial of this drug against ordinary heparin in critically ill patients found no difference in leg clots, its main measure. Fewer lung clots were seen, but that was a secondary finding.
What was measured
Proximal leg deep vein thrombosis on protocol ultrasonography, 5.1% against 5.8%, p=0.57
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
PROTECT (NCT00182143) randomised 3,764 intensive care patients to dalteparin 5,000 IU once daily with a placebo injection, or unfractionated heparin 5,000 IU twice daily, testing dalteparin for superiority. The primary outcome, proximal leg deep vein thrombosis diagnosed on protocol compression ultrasonography, occurred in 96 of 1,873 dalteparin patients (5.1%) against 109 of 1,873 heparin patients (5.8%) — hazard ratio 0.92 (95% CI 0.68 to 1.23), p=0.57. The trial’s stated conclusion is that dalteparin "was not superior". Pulmonary embolism, a secondary outcome, was lower: 24 patients (1.3%) against 43 (2.3%), hazard ratio 0.51 (95% CI 0.30 to 0.88), p=0.01. Major bleeding did not differ (hazard ratio 1.00, p=0.98) nor did in-hospital death (0.92, p=0.21). In prespecified per-protocol analysis fewer dalteparin patients developed heparin-induced thrombocytopenia (hazard ratio 0.27, 95% CI 0.08 to 0.98, p=0.046). The pulmonary embolism figure is the one most often quoted from this trial and it is a secondary endpoint reported after the primary failed, which is the reason it belongs here rather than under measured findings alone.
Written into the record, not signed off as a reviewed claim
FRISC: the coronary benefit was real for six days and gone by five months
In plain words
In unstable angina, this drug cut deaths and heart attacks by two thirds in the first six days. Four to five months after treatment stopped there was no difference at all, and the effect was confined to non-smokers.
What was measured
Death or new myocardial infarction at 6 days (1.8% against 4.8%), at 40 days, and at 4 to 5 months after treatment (no significant difference)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
FRISC randomised 1,506 patients with unstable angina or non-Q-wave myocardial infarction, double-blind, to subcutaneous dalteparin or placebo alongside aspirin. The primary endpoint of death or new myocardial infarction during the first six days occurred in 13 patients (1.8%) against 36 (4.8%), risk ratio 0.37 (95% CI 0.20 to 0.68). Need for intravenous heparin was 3.8% against 7.7% and the composite endpoint 5.4% against 10.3%. The differences persisted at 40 days, but the publication reports two important qualifications in the same paragraph: subgroup analysis showed the 40-day effect was "confined to non-smokers (80% of sample)", and survival analysis showed a risk of reactivation and reinfarction when the dose was reduced, more pronounced in smokers. Four to five months after treatment ended there were no significant differences in death, myocardial infarction or revascularisation. A treatment that works while it is running and leaves nothing behind is a legitimate treatment; describing it as preventing heart attacks without the time qualifier is not.
Source
Fragmin during Instability in Coronary Artery Disease (FRISC) Study Group. Lancet 1996;347:561-568
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Hokusai VTE Cancer ended dalteparin’s fifteen years as the only answer
In plain words
In 2018 a tablet was tested directly against dalteparin in cancer patients with clots. The combined result was a tie, and the field stopped treating daily injections as the only option.
What was measured
Recurrent venous thromboembolism 11.3% on dalteparin against 7.9% on edoxaban, and major bleeding 4.0% against 6.9%
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Hokusai VTE Cancer (NCT02073682) randomised 1,046 analysable patients with cancer-associated venous thromboembolism to edoxaban after at least five days of low molecular weight heparin, or to subcutaneous dalteparin at 200 IU/kg once daily for one month followed by 150 IU/kg — the CLOT regimen — for up to 12 months. The composite of recurrent venous thromboembolism or major bleeding occurred in 12.8% against 13.5%, hazard ratio 0.97 (95% CI 0.70 to 1.36, p=0.006 for non-inferiority, p=0.87 for superiority). Recurrent venous thromboembolism was 7.9% against 11.3% (risk difference -3.4 percentage points, 95% CI -7.0 to 0.2) and major bleeding 6.9% against 4.0% (risk difference 2.9 points, 95% CI 0.1 to 5.6). Dalteparin lost on recurrence and won on bleeding, and the composite recorded a tie. The practical consequence is that dalteparin is now one option rather than the option, and that the choice turns on tumour site — the edoxaban bleeding excess was concentrated in gastrointestinal cancers.
Written into the record, not signed off as a reviewed claim
The routine clotting screen does not see this drug at all
In plain words
Standard blood clotting tests come back normal on dalteparin. That is expected and correct, and it regularly gets misread as the drug not working.
What was measured
Absence of significant change in prothrombin time, thrombin time and activated partial thromboplastin time at doses up to 10,000 anti-factor Xa units
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The United States label reports that subcutaneous doses of up to 10,000 anti-factor Xa units, given as a single dose or as two 5,000 unit doses twelve hours apart, produced no significant change in platelet aggregation, fibrinolysis, prothrombin time, thrombin time or activated partial thromboplastin time in healthy subjects. Seven days of 5,000 units twice daily in abdominal surgery patients did not markedly affect the activated partial thromboplastin time, platelet factor 4 or lipoprotein lipase. This follows directly from the pharmacology: the activated partial thromboplastin time is a thrombin-dependent readout, and a mixture whose chains are mostly too short to inhibit thrombin will barely move it. The assay that does read dalteparin is a chromogenic anti-factor Xa activity level calibrated to dalteparin against the WHO reference standard, and potency is expressed in anti-factor Xa units for the same reason.
Source
FRAGMIN (dalteparin sodium) injection, United States prescribing information, section 12.2 Pharmacodynamics
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
It has never been compared with enoxaparin in a large outcome trial
In plain words
The two most used low molecular weight heparins are made by different chemistries and behave differently in the laboratory. No large trial has ever compared them against each other on patient outcomes.
What was measured
That the low molecular weight heparins are interchangeable within their class — each is defined by its own depolymerisation chemistry and chain-length distribution, and no large randomised outcome trial has compared any two of them
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Dalteparin is made by controlled nitrous acid depolymerisation, leaving 2,5-anhydro-D-mannitol end groups and an average molecular weight of about 5,000 daltons. Enoxaparin is made by alkaline depolymerisation of a benzyl ester, leaving a 2-O-sulfo-4-enepyranosuronic acid at one end and a 1,6-anhydro derivative on 15 to 25% of chains, with an average of about 4,500 daltons. Those are different molecules by any structural test, and their anti-factor Xa to anti-thrombin balances differ correspondingly. No large randomised outcome trial has ever compared them in any indication. In practice they are treated as interchangeable within a class, which is an inference from shared mechanism rather than a finding — and it is the same inference the generic enoxaparin approval rests on, applied across products rather than within one.
Source
FRAGMIN (dalteparin sodium) and LOVENOX (enoxaparin sodium) United States prescribing information, section 11 Description in each
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Where else this substance is registered
FDA substance identifier (UNII)
S79O08V79F
CAS registry number
9005-49-6
RxNorm concept
67109
EMA substance identifier
100000127573
DrugBank
DB06779
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Reviewed first-read answer.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S11, S1.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
1 approved application covers products containing this substance. The earliest was NDA020287, approved 19941222 to PFIZER.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A low molecular weight heparin made by a different chemistry from enoxaparin, which cut recurrent clots in cancer patients from 15.8% to 8.0% against a warfarin-type drug over six months without increasing major bleeding — and whose separate attempt to show that anticoagulation prolongs cancer survival missed its primary endpoint at p=0.19.
Recorded evidence blocks (9)
Q2
On the Dalteparin label: indicated for what?
"FRAGMIN is a low molecular weight heparin (LMWH) indicated for • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction ( 1.1 ) • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during…": indications and usage on Dalteparin's label. DailyMed label · 23527b8b-9b28-4e6d-9751-33b143975ac7 · 2025-09-30
Q3
74 registered trials of Dalteparin — at which phases?
Registered studies posting no result
48 of 74
74 registered studies of Dalteparin: 25 phase3, 17 phase2, 17 phase4, 8 na or unstated, 7 na, 3 phase1, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
1.47 ± 0.3 hours; The corresponding mean disposition half-lives were 1.47 ± 0.3 hours and 2.5 ± 0.3 hours.
bioavailabilitypharmacokinetics
87 ± 6 %; Absolute bioavailability in healthy volunteers, measured as the anti-Xa activity, was 87 ± 6%.
recorded 2025-09-30 · last checked 2026-09-04
Q7
Which 25 trials of Dalteparin posted no result?
Posted no result
25 of 25 completed trials
Registrations
NCT00006083, NCT00003674, NCT00216866, NCT00138099, NCT00135876 and NCT00028678, and 19 more
Completion dates
oldest 2000-11; newest 2024-05-01
Show the evidence
Trial
NCT00006083
2000-11
NCT00003674
2004-04
NCT00216866
2006-03
NCT00138099
2006-06
NCT00135876
2006-11
NCT00028678
2007-06
14 further recorded trials
NCT00260988
2008-11
NCT01714297
2009-04
NCT00239980
2010-01
NCT00182143
2010-06
NCT01444612
2010-11
NCT00462852
2011-11
NCT01245998
2014-01-01
NCT01648036
2014-02
NCT00967382
2014-03
NCT01741506
2015-04
NCT01061411
2017-04-21
NCT03218514
2017-07
NCT01727427
2017-12
NCT02746185
2018-04-25
Q8
At the median, Dalteparin's trials enrolled 109 people — anything larger?
Median enrolment
109
Largest enrolment
4068
Registered trials counted
72
Q9
What do 766 spontaneous reports say about Dalteparin — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Dalteparin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 766 reaction mentions were counted: pulmonary embolism 118; premature baby 105; haemoglobin decreased 100; deep vein thrombosis 93. FAERS via Open Targets · CHEMBL1201460 · 2026-06-24
Show the evidence
pulmonary embolism
118
premature baby
105
haemoglobin decreased
100
deep vein thrombosis
93
thrombocytopenia
92
haemorrhage
65
4 more recorded rows
heparin-induced thrombocytopenia
53
gastrointestinal haemorrhage
49
low birth weight baby
46
haematoma
45
recorded 2026-06-24 · last checked 2026-09-04
Q10
Which 10 reactions does Dalteparin's label not list?
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.