This page shows what was measured, who it was measured in, and what that does not settle.
What Fibrinogen Concentrate (Human) does in the body
Injected, it restores the supply of raw material so that a clot can actually be built.
A clot is a mesh, and fibrinogen is the thread it is woven from. It circulates dissolved in the blood until thrombin cuts two short pieces off each molecule, at which point the remainder becomes sticky and links up with its neighbours into an insoluble net. This product is that thread, purified from donated plasma and freeze-dried.
Why people take it. Replacing the protein that clots are actually made of, in people born without enough of it
What happened in people
More allogeneic blood product units in the first 24 hours on concentrate than on placebo in aortic surgery, 5.0 against 3.0 (p=0.026)
✎ 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 recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
Stocked in cardiac theatres, obstetric units and trauma centres in Europe and increasingly in North America, overwhelmingly for the acquired deficiency it is not licensed to treat
Where it acts
Blood plasma, and the growing fibrin mesh at the site of injury
Kind of result
A number that stands in for health
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The organism is Homo sapiens, a species. It is also called human.
NCBI Taxonomy · 9606 · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 115 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.
Red cell, platelet and plasma units administered during the 24 hours after cardiopulmonary bypass
✓ The study showed what it set out to show
Who was studied
FIBRES (NCT03037424) — fibrinogen concentrate versus cryoprecipitate in cardiac surgery
How many people
735
Study design
Randomised non-inferiority trial at 11 Canadian hospitals, stopped early for non-inferiority
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
16.3 units (95% CI 14.9 to 17.8) versus 17.0 units (95% CI 15.6 to 18.6), ratio 0.96, p < 0.001 for non-inferiority and p = 0.50 for superiority
Repeated elsewhere
Unreplicated
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. Stopped at an interim analysis after 827 of a planned 1,200 randomisations. The comparator is a blood component of variable fibrinogen content, so the trial establishes equivalence to an imprecise standard rather than efficacy against no treatment.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion of a reconstituted lyophilised concentrate
Interval reported. 95% CI 14
Written into the record, not signed off as a reviewed claim.
5.0 units (IQR 2.0 to 11.0) on concentrate versus 3.0 units (IQR 0.0 to 7.0) on placebo, p = 0.026 — in the direction opposite to the hypothesis
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. Fewer patients avoided transfusion altogether on the concentrate, 15.4% versus 28.4% (p=0.047). Only 152 of 519 randomised patients met the bleeding criterion to receive study medication, and pretreatment fibrinogen concentrations were in the normal range.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion of a reconstituted lyophilised concentrate
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
FIBRES — Fibrinogen Replenishment in Surgery (NCT03037424) · a recorded source, not a stored snapshot
All-cause mortality at 28 days in the intention-to-treat population
✗ The study did not show it
Who was studied
CRYOSTAT-2 (NCT04704869) — early empirical high-dose fibrinogen replacement in trauma
How many people
1604
Study design
International randomised open-label parallel-group controlled trial, 26 trauma centres
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
25.3% on cryoprecipitate versus 26.1% on standard care, odds ratio 0.96 (95% CI 0.75 to 1.23), p = 0.74
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. Thrombotic events 12.7% versus 12.9%, so the null result is not explained by offsetting harm. The trial tested cryoprecipitate rather than the concentrate, and therefore the strategy of early fibrinogen replacement rather than this product.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion of a reconstituted lyophilised concentrate
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
FIBRES — Fibrinogen Replenishment in Surgery (NCT03037424) · a recorded source, not a stored snapshot
Maximum clot firmness measured by thromboelastometry
✓ The study showed what it set out to show
Who was studied
Licensing studies in congenital fibrinogen deficiency
How many people
36
Study design
Prospective pharmacokinetic study plus a multicentre non-interventional retrospective cohort with 12-month prospective follow-up
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Mean increase in maximum clot firmness of 8.9 mm after infusion; haemostatic efficacy rated effective in 97% of bleeding events and 97.5% of surgical bleeding
Repeated elsewhere
Unreplicated
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. Fourteen subjects in the pharmacokinetic study and 22 in the retrospective cohort, with no control group and a laboratory primary endpoint. The efficacy ratings are retrospective investigator assessments.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion of a reconstituted lyophilised concentrate
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
FIBRES — Fibrinogen Replenishment in Surgery (NCT03037424) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 4 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
Fibrinogen Concentrate (Human)
What a person takes: Intravenous infusion of a reconstituted lyophilised concentrate.
The measurement behind this step
Supplied as a freeze-dried powder reconstituted with sterile water and infused slowly into a vein. Because it is a purified protein with no cells and no plasma antibodies, it requires no blood group matching and no thawing, which is the practical advantage that has driven its adoption over cryoprecipitate more than any trial result has.
Getting in
Freeze-dried powder, reconstituted and infused
Comes as a vial of powder with a known amount of protein in it, mixed with water and given into a vein. The known amount is the point: the alternative, cryoprecipitate, varies from bag to bag.
╌╌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
Potency is assigned by clottable protein content, so the dose delivered is defined in grams of functional fibrinogen rather than in pooled units of unknown concentration. There is no thawing and no blood group matching, because the product contains no cells and no antibodies.
Fibrinogen already circulates dissolved in blood, at a higher concentration than any other clotting protein. The infused material simply adds to that pool.
╌╌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
Fibrinogen circulates at roughly 2 to 4 g/L in health, an order of magnitude above the other coagulation factors by mass, which is why depletion is measured in grams and replacement is dosed in grams. It is a 340 kDa hexamer of two alpha, two beta and two gamma chains held together by disulfide bonds.
Fibrinogen is deliberately unsticky while it circulates. Thrombin cuts off the small caps that keep it that way, and what is left is sticky at both ends.
╌╌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
Thrombin cleaves fibrinopeptide A from the amino terminus of each alpha chain and fibrinopeptide B from each beta chain, exposing polymerisation knobs that fit complementary holes in the gamma and beta nodules of neighbouring molecules. Nothing is consumed catalytically; the protein becomes the structure.
The molecules link up into a mesh and are then welded together
The sticky ends interlock into long strands that branch into a net. A separate enzyme then cross-links the strands so the net can resist being pulled apart.
╌╌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
Half-staggered double-stranded protofibrils aggregate laterally into fibres and branch into a three-dimensional network. Factor XIIIa introduces covalent gamma-glutamyl-epsilon-lysyl cross-links between gamma chains and within the alpha chains, which is what converts a soluble mesh into one that resists both mechanical disruption and plasmin. Cryoprecipitate supplies factor XIII as well; the concentrate does not, which is a real difference between the two products.
Put a sample in a device that measures how stiff the clot becomes, and the number goes up within minutes. This is the measurement the licence was granted on.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Maximum clot firmness rose by a mean of 8.9 mm after infusion in the licensing studies, and REPLACE confirmed an immediate rise in both plasma fibrinogen concentration and fibrin-based clot strength. Clot firmness in a viscoelastic assay is close to a direct readout of fibrinogen concentration, which is what makes it such an attractive and such a circular endpoint.
Against cryoprecipitate in cardiac surgery, equivalent. Against placebo in aortic surgery, more transfusion, not less. As an early strategy in trauma, no lives saved.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
FIBRES: 16.3 against 17.0 units transfused, ratio 0.96, non-inferior. REPLACE: 5.0 against 3.0 units, p=0.026, with fewer patients avoiding transfusion, 15.4% against 28.4%, p=0.047. CRYOSTAT-2: 28-day mortality 25.3% against 26.1%, odds ratio 0.96 (95% CI 0.75 to 1.23). Three randomised trials, three populations, and a clot-firmness effect that is identical in all of them.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 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.
A small number of people with an inherited deficiency, and a far larger number of bleeding surgical, obstetric and trauma patients treated off-label in intensive care and the operating theatre.
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.
Where the result stopped carrying
REPLACE found more allogeneic transfusion on the concentrate than on placebo, with fewer patients avoiding transfusion entirely (15.4% against 28.4%)
CRYOSTAT-2 found no survival benefit from early empirical fibrinogen replacement in 1,604 bleeding trauma patients
FIBRES was stopped early at an interim analysis, having demonstrated non-inferiority but not superiority (p=0.50)
The label explicitly excludes dysfibrinogenaemia, where the protein is present but does not work — the one deficiency state that replacement cannot fix
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.
There was nothing to correct
Where a level is already normal, topping it up may change nothing.
On this record: Stocked in cardiac theatres, obstetric units and trauma centres in Europe and increasingly in North America, overwhelmingly for the acquired deficiency it is not licensed to treat
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 (10)
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.
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
Intravenous infusion of a reconstituted lyophilised concentrate
✎ 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
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Supplied as a freeze-dried powder reconstituted with sterile water and infused slowly into a vein.
✎ 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. The rest of the recorded wording: Because it is a purified protein with no cells and no plasma antibodies, it requires no blood group matching and no thawing, which is the practical advantage that has driven its adoption over cryoprecipitate more than any trial result has.
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
No boxed warning. The label warns that thrombosis may occur spontaneously in patients with congenital fibrinogen deficiency with or without fibrinogen replacement therapy, and that thromboembolic events have been reported with the product; it directs that benefits be weighed against thrombosis risk and that patients be monitored for unexplained chest or leg pain, haemoptysis and breathlessness. It is plasma-derived, so a residual theoretical risk of transmissible agents remains despite heat treatment at 60°C for 20 hours, two glycine precipitation steps and a reported cumulative virus reduction of at least 9.6 log10 for HIV. Hypersensitivity reactions can occur. It supplies fibrinogen alone, not the factor XIII or von Willebrand factor that cryoprecipitate also contains.
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
Intravenous infusion of a reconstituted lyophilised concentrate
✎ 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
A recorded note compares this form with the others that are sold. It is kept below, word for word.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
The recorded note, unchanged: Because it is a purified protein with no cells and no plasma antibodies, it requires no blood group matching and no thawing, which is the practical advantage that has driven its adoption over cryoprecipitate more than any trial result has.
No source is stored against this line.
What is recorded as being sold
5711 marketed supplement labels list this ingredient, classed as botanical, botanical with nutrients and other combinations.
Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
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.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Fibrinogen Concentrate (Human) 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 a licence granted on clot firmness in 36 people with an inherited deficiency extends to bleeding surgical, obstetric and trauma patients whose fibrinogen has been consumed
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 a firmer clot in a viscoelastic assay means less bleeding in the patient — the most direct pharmacodynamic effect in this group, and the one whose clinical translation has failed twice
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 non-inferiority shown against cryoprecipitate establishes efficacy; the comparator itself has never beaten standard care on mortality in trauma
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 replacing fibrinogen consumed by an ongoing process works the way replacing fibrinogen that was never made does
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.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records 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 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 Fibrinogen Concentrate (Human) 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.
The licence rests on clot firmness measured in thirty-six people
In plain words
Approval in 2009 was based on a pharmacokinetic study of 14 subjects and a retrospective cohort of 22, with the main efficacy measurement being how firm a clot got in a laboratory device — not whether anybody stopped bleeding faster.
What was measured
Maximum clot firmness by thromboelastometry, mean increase of 8.9 mm after infusion
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The RiaSTAP clinical studies section describes a prospective pharmacokinetic study in 14 subjects aged 8 to 61 and a multicentre non-interventional retrospective cohort study with 12-month prospective follow-up in 22 subjects, 11 paediatric and 11 adult. The primary efficacy endpoint was maximum clot firmness measured by thromboelastometry, which rose by a mean of 8.9 mm after infusion. Haemostatic efficacy was rated effective in 97% of bleeding events and 97.5% of surgical bleeding, in a retrospective, uncontrolled cohort. Congenital afibrinogenaemia is rare enough that a controlled trial is not realistically possible, so the approval pathway is defensible. What is not defensible is treating that evidence base as though it licenses the far larger acquired-deficiency population the product is actually used in.
Written into the record, not signed off as a reviewed claim
Against cryoprecipitate in cardiac surgery it is genuinely equivalent
In plain words
In 735 cardiac surgery patients bleeding with a low fibrinogen level, the concentrate and cryoprecipitate produced the same transfusion requirement over the next 24 hours. The trial stopped early because non-inferiority was already established.
What was measured
Total red cell, platelet and plasma units transfused during the 24 hours after cardiopulmonary bypass
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
FIBRES randomised adult patients with clinically significant bleeding and hypofibrinogenaemia after cardiopulmonary bypass at 11 Canadian hospitals to 4 g of fibrinogen concentrate or 10 units of cryoprecipitate per ordered dose. Of 827 randomised, 735 were treated and analysed: median age 64, 72% complex operations, 95% moderate to severe bleeding, pretreatment fibrinogen 1.6 g/L. Mean 24-hour post-bypass allogeneic transfusion was 16.3 units (95% CI 14.9 to 17.8) against 17.0 units (95% CI 15.6 to 18.6), ratio 0.96 (one-sided 97.5% CI to 1.09, p<0.001 for non-inferiority; two-sided 95% CI 0.84 to 1.09, p=0.50 for superiority). The trial met its a priori stopping criterion for non-inferiority at the interim analysis after 827 of a planned 1,200 patients. Thromboembolic events occurred in 7.0% against 9.6%.
Written into the record, not signed off as a reviewed claim
In aortic surgery it increased transfusion instead of reducing it
In plain words
A blinded trial gave fibrinogen concentrate or placebo to bleeding aortic surgery patients. The treated group received more blood products over the next day, not fewer, and fewer of them avoided transfusion entirely.
What was measured
Allogeneic blood product units administered in the first 24 hours, and proportion of patients avoiding transfusion
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
REPLACE randomised 519 patients undergoing elective aortic surgery on cardiopulmonary bypass across 34 centres, of whom 152 (29%) met the bleeding criterion for study medication — a five-minute bleeding mass of 60 to 250 g after separation from bypass and surgical haemostasis. Median pretreatment five-minute bleeding mass was 107 g on concentrate and 91 g on placebo (p=0.13). Allogeneic blood product units in the first 24 hours were 5.0 (IQR 2.0 to 11.0) on concentrate against 3.0 (IQR 0.0 to 7.0) on placebo, p=0.026. Fewer patients avoided transfusion altogether on concentrate, 15.4% against 28.4%, p=0.047. The concentrate did exactly what it says on the vial — plasma fibrinogen concentration and fibrin-based clot strength rose immediately — and the patients received more blood. The authors describe the result as unexpected and contrary to previous studies, and point to low bleeding rates, normal-range pretreatment fibrinogen and variable adherence to the transfusion algorithm.
Written into the record, not signed off as a reviewed claim
Early fibrinogen replacement in trauma did not save a single extra life
In plain words
CRYOSTAT-2 gave every bleeding trauma patient a large early dose of fibrinogen replacement on top of standard care. Death at 28 days was 25.3% against 26.1% on standard care — no difference.
What was measured
All-cause mortality at 28 days in the intention-to-treat population
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
CRYOSTAT-2 randomised 1,604 injured adults requiring activation of a major haemorrhage protocol at 26 UK and US major trauma centres between August 2017 and November 2021, to standard care or standard care plus three pools of cryoprecipitate — six grams of fibrinogen equivalent — within 90 minutes of randomisation and three hours of injury. Median Injury Severity Score was 29, 36% had penetrating injury and 33% arrived with a systolic pressure below 90 mmHg. All-cause 28-day mortality in the intention-to-treat population was 26.1% on standard care against 25.3% with cryoprecipitate, odds ratio 0.96 (95% CI 0.75 to 1.23, p=0.74). Thrombotic events were 12.9% against 12.7%. The trial tested the strategy of early empirical fibrinogen replacement rather than this specific product, and that strategy is the one on which most off-label use of fibrinogen concentrate rests.
Written into the record, not signed off as a reviewed claim
Almost all of its use is for a deficiency it is not licensed to treat
In plain words
The label covers people born without enough fibrinogen — a very rare condition. Most of the product goes to people who had normal fibrinogen until they bled it away, which is a different problem with different evidence.
What was measured
That replacing a consumed clotting protein in a bleeding patient works the way replacing an absent one does in a patient born without it
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The RiaSTAP indication is confined to acute bleeding episodes in congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia, with dysfibrinogenaemia explicitly excluded. Acquired hypofibrinogenaemia after cardiopulmonary bypass, in post-partum haemorrhage and in trauma is orders of magnitude more common, and it is where the randomised evidence sits — FIBRES, REPLACE and, for the strategy rather than the product, CRYOSTAT-2. The distinction is not pedantic. In congenital deficiency the protein is simply absent and replacing it restores something that was never there. In acquired depletion the fibrinogen was consumed by a process that is still running, and replacing it feeds a fire that is still burning. REPLACE and CRYOSTAT-2 are what that difference looks like when it is measured.
Written into the record, not signed off as a reviewed claim
The clot firmness rises every time. That part is not in doubt.
In plain words
Across every study, giving the concentrate raises the fibrinogen level and the measured firmness of the clot within minutes. What varies is whether that helps.
What was measured
Maximum clot firmness by thromboelastometry and plasma fibrinogen concentration after infusion
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Maximum clot firmness rose by a mean of 8.9 mm after infusion in the licensing studies. In REPLACE, the concentrate immediately increased plasma fibrinogen concentration and fibrin-based clot strength — in the arm that then received more blood products. This is the most direct pharmacodynamic relationship in this whole group of drugs: a structural protein is missing, it is put back, and the mechanical property it determines improves in proportion. The audit finding is not that the mechanism is doubtful. It is that a mechanically firmer clot in a viscoelastic device and a patient who stops bleeding are two different measurements, and the trials that measured the second one have split.
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What is not here
8 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.
How this medicine reached us — 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.
Purified human fibrinogen, licensed in the United States in 2009 for a rare inherited deficiency on the strength of a thromboelastometry measurement in 36 subjects, and now given mostly to bleeding surgical and trauma patients it was never tested in — where one randomised trial found it as good as cryoprecipitate, another found it increased transfusion rather than reducing it, and a 1,604-patient trauma trial of the same replacement strategy found no survival benefit at all.
Recorded evidence blocks (5)
Q1
33 registered trials of Fibrinogen Concentrate (Human) — at which phases?
Registered studies posting no result
25 of 33
33 registered studies of Fibrinogen Concentrate (Human): 14 phase2, 9 phase3, 6 phase4, 3 na, 3 na or unstated, 2 phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
0 with a PubMed record
Show the evidence
phase2
14
phase3
9
phase4
6
na
3
na or unstated
3
phase1
2
6 more recorded rows
completed
20
unknown
6
terminated
3
withdrawn
2
not yet recruiting
1
recruiting
1
recorded 2026-09-01 · last checked 2026-09-04
Q2
4 of Fibrinogen Concentrate (Human)'s trials stopped: accrual/recruitment, other?
"Insufficient funding to complete total projected enrollment"; 4 of 33 registered studies
Show the evidence
Trial
NCT01283321
terminated; "Insufficient funding to complete total projected enrollment"
NCT02528708
withdrawn; "The study never began."
NCT02540434
terminated; "Feasibility issues prevent completion of recruitment."
NCT03793426
terminated; "FORMA-07 was initiated as a requirement imposed by the U.S. FDA as part of Octapharma's regulatory obligations. After approving Fibryga for treatment of acquired fibrinogen deficiency in 2024, FDA has agreed that the study may now be…"
recorded 2026-09-01 · last checked 2026-09-04
Q3
Which 13 trials of Fibrinogen Concentrate (Human) posted no result?
Posted no result
13 of 13 completed trials
Registrations
NCT00701142, NCT01187225, NCT01359878, NCT01475669, NCT01124981 and NCT01471730, and 7 more
Completion dates
oldest 2010-04; newest 2024-02-06
Show the evidence
Trial
NCT00701142
2010-04
NCT01187225
2011-11
NCT01359878
2013-07
NCT01475669
2014-09
NCT01124981
2014-12
NCT01471730
2014-12
7 further recorded trials
NCT00968045
2015-05
NCT02203968
2015-12
NCT02427217
2017-12-06
NCT02745041
2018-02-20
NCT02864875
2018-07
NCT04106895
2020-02-10
NCT05780125
2024-02-06
Q4
At the median, Fibrinogen Concentrate (Human)'s trials enrolled 42 people — anything larger?
Median enrolment
42
Largest enrolment
900
Registered trials counted
33
Q5
What do 64 spontaneous reports say about Fibrinogen Concentrate (Human) — 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.
Fibrinogen Concentrate (Human) appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 64 reaction mentions were counted: abdominal abscess 9; intestinal obstruction 8; post procedural bile leak 7; anaphylactic shock 7. FAERS via Open Targets · CHEMBL2109072 · 2026-06-24
Show the evidence
abdominal abscess
9
intestinal obstruction
8
post procedural bile leak
7
anaphylactic shock
7
foetal anaemia
6
lymphocele
6
4 more recorded rows
foetal growth restriction
6
postoperative wound infection
5
haemorrhage foetal
5
haemorrhage in pregnancy
5
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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
✗ 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: 3 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
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