HypofibrinogenemiaCRYO-FIRSTNCT07218185
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
An observational study of Hypofibrinogenemia and Hemorrhage, run by Cerus Corporation at 4 sites in United States.
Trial summary
The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) in trauma patients with hemorrhagic shock (HS) and functional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypofibrinogenemia, Hemorrhage, Trauma Associated Hemorrhage
- What is being tested?
- Pathogen Reduced Cryoprecipitated Fibrinogen Complex
- How many people
- 320 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Sep 2026to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male and female trauma patients, age ≥18 years or estimated weight ≥50 kg if age is unknown, with evidence of hemorrhagic shock and functional hypofibrinogenemia by admission point-of-care testing, admitted to a participating trauma center within 1 hour of sustaining injury.
Who may be able to join
- Traumatic injury
- Age ≥18 years or estimated weight ≥50 kg, if age unknown
- Presenting to a participating trauma center ≤1 hour from estimated time of injury
- Functional hypofibrinogenemia upon arrival to the trauma center as measured by point-of-care testing (Quantra®) with FCS <1.6 hPa
- Hemorrhagic shock, defined as:
- Initiation of transfusion of any uncrossmatched blood product;
Show all 10Show fewer
- Evidence of active hemorrhage as judged by the attending trauma surgeon; and
- Initiation of the participating trauma center's massive transfusion protocol (MTP)
- IFC administration is clinically indicated per the treating physician
- IFC is available at the time of enrollment
Who cannot join
- Suspected isolated severe brain or spinal cord injury
- Isolated drowning or hanging
- Burns >20% total body surface area (TBSA)
- Known pregnancy
- Admitted from a correctional facility
- Known do not resuscitate (DNR) order
Show all 9Show fewer
- Traumatic arrest >5 minutes, defined as continuous CPR >5 minutes at any time point prior to enrollment in the study
- Isolated fall from standing
- Emergency Department (ED) thoracotomy
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Anschutz Medical Center, University of Colorado
Aurora, Colorado, 80045
R Adams Cowley Shock Trauma Center, University of Maryland
Baltimore, Maryland, 21201
Ryder Trauma Center/Jackson Memorial Hospital, University of Miami
Miami, Florida, 33136
Barnes Jewish Hospital, Washington University of Saint Louis
St Louis, Missouri, 63110
About this study
Official title: Cryo-FIRST: Cryoprecipitate For Immediate Resuscitation in Severe Trauma: Effectiveness of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) for Treatment of Trauma Associated Hemorrhage
The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) in trauma patients with hemorrhagic shock (HS) and functional hypofibrinogenemia. This study will determine whether rapid point-of-care testing for functional hypofibrinogenemia and availability of a shelf-stable fibrinogen complex (IFC) results in shorter time to administration of fibrinogen replacement and correction of functional hypofibrinogenemia, as compared with historical controls and published literature using conventional cryoprecipitate-AHF (CRYO-AHF).
This study aims to:
- Demonstrate the feasibility and response to early administration of pre-thawed IFC when ordered during initial resuscitation of severely injured patients with HS and functional hypofibrinogenemia.
- Assess the effectiveness of early administration of pre-thawed IFC on correction of functional hypofibrinogenemia and on proximate process measures of resuscitation, including time to hemostasis, time to completion of resuscitation, and total volume of resuscitation.
- Assess clinical outcomes in severely injured patients with HS and functional hypofibrinogenemia receiving early administration of pre-thawed IFC.
Read the detailed description
This is a multicenter, pragmatic, observational, single-arm study evaluating the feasibility and effectiveness of early administration of pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) in trauma patients with hemorrhagic shock and functional hypofibrinogenemia.
Adult trauma patients age ≥18 years, or estimated weight ≥50 kg if age is unknown, who present to a participating trauma center within 1 hour of estimated time of injury and meet criteria for hemorrhagic shock will be screened using the point-of-care Quantra® Hemostasis Analyzer. Functional hypofibrinogenemia is defined as FCS <1.6 hPa by Quantra® point-of-care testing. Patients are eligible only if cryoprecipitate administration is clinically indicated by the treating physician, IFC is available at the time of enrollment, and the patient will receive IFC per standard of care.
Following administration of IFC, an additional Quantra® point-of-care test will be completed at completion of resuscitation (COR), defined as discontinuation of the massive transfusion protocol (MTP), to evaluate fibrinogen response. Additional IFC may be administered if additional hemostatic correction is determined to be needed by the treating clinician, repeat point-of-care testing, or clinical judgment.
Primary outcomes are the proportion of patients with hemorrhagic shock and functional hypofibrinogenemia who receive IFC within 60 minutes of presentation to the participating trauma center and the proportion of patients with successful correction of functional hypofibrinogenemia at COR. Secondary outcomes include time to hemostasis, estimated blood loss, transfusion burden/total volume of resuscitation, mortality at 3 hours, 6 hours, 24 hours, and 30 days or in-hospital mortality, and adverse clinical outcomes through 30 days, hospital discharge, or death, whichever occurs first. Outcomes may be compared descriptively with historical controls, site medical databases, and published literature using CRYO-AHF.
Four Level 1 trauma centers will enroll approximately 320 patients over approximately 24 months.
- Being tested
- Pathogen Reduced Cryoprecipitated Fibrinogen Complex
- Keywords
- Fibrinogen, Hemorrhage, Trauma, Resuscitation, INTERCEPT Fibrinogen Complex, Pathogen Reduced Cryoprecipitated Fibrinogen Complex, Hemorrhagic Shock, Quantra
- Medical subject headings
- Afibrinogenemia, Hemorrhage, Shock, Hemorrhagic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathogen Reduced Cryoprecipitated Fibrinogen ComplexBiological
Also called INTERCEPT Fibrinogen Complex, IFC
Pre-thawed IFC will be administered per standard of care when cryoprecipitate administration is clinically indicated by the treating physician and IFC is available. Participants must have functional hypofibrinogenemia by Quantra® POC testing with FCS <1.6 hPA. Additional IFC may be administered based on repeat POC testing or clinical judgment.
| Study group | Role | What they receive |
|---|---|---|
| IFC arm | Subjects will receive Pathogen Reduced Cryoprecipitated Fibrinogen Complex (IFC) for fibrinogen supplementation. Receives: Biological: Pathogen Reduced Cryoprecipitated Fibrinogen Complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
IFC administration within 60 minutes of presentation
Proportion (%) of patients with hemorrhagic shock and functional hypofibrinogenemia who receive IFC within 60 minutes of presentation to the participating trauma center.
Measured: From presentation/admission to the participating trauma center to initial IFC transfusion, assessed up to 60 minutes after presentation.
Correction of functional hypofibrinogenemia after IFC transfusion
Proportion of patients with successful correction of functional fibrinogen, defined as FCS ≥1.6 hPa by Quantra® point-of-care testing after transfusion of IFC, measured at completion of resuscitation (COR).
Measured: At completion of resuscitation (COR), defined as discontinuation of the massive transfusion protocol (MTP), after IFC transfusion.
Secondary outcomes (2)
Mortality
Mortality incidence at 3 hours, 6 hours, 24 hours, and 30 days or in-hospital mortality.
Measured: 3, 6, and 24 hours after admission/enrollment; 30 days or in-hospital mortality.
Clinical complications/adverse clinical outcomes.
Incidences of acute blood loss anemia, abdominal compartment syndrome, acute kidney injury, acute renal failure, acute respiratory distress syndrome, bleeding after hemostasis requiring intervention, coagulopathy, febrile non-hemolytic transfusion reaction, hospital-acquired pneumonia, intraabdominal infection, liver failure, MOD, MOF, myocardial infarction, sepsis, stroke, surgical site infection, symptomatic and asymptomatic deep vein thrombosis, symptomatic and asymptomatic pulmonary embolism, systemic inflammatory response syndrome, transfusion-associated circulatory overload (TACO), transfusion-associated lung injury (TRALI), transfusion-related allergic reactions, transfusion-related hyperkalemia in the first 24 hours, transfusion-related hypocalcemia in the first 24 hours, and ventilator-associated pneumonia.
Measured: From enrollment through 30 days, hospital discharge, or death, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start15 Sep 2026
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HypofibrinogenemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cerus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Coalition for National Trauma Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218185
- Sponsor's protocol ID
- CLI 00193
- Acronym
- CRYO-FIRST
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Rossetto A, Wohlgemut JM, Brohi K, Davenport R. Sonorheometry versus rotational thromboelastometry in trauma: a comparison of diagnostic and prognostic performance. J Thromb Haemost. 2023 Aug;21(8):2114-2125. doi: 10.1016/j.jtha.2023.04.031. Epub 2023 May 8.
PubMed 37164268Huffman G, Wilken N, Loh JH, Fazal M, Lei I, Myers A, et al. Analysis of Wastage, Savings, and Maternal and Pediatric Outcomes for Pooled Pathogen Reduced Cryoprecipitate versus Conventional Cryoprecipitate. Baylor College of Medicine; Abstract AABB Annual Meeting. 2024.
Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.
PubMed 25647203Davenport R, Curry N, Fox EE, Thomas H, Lucas J, Evans A, Shanmugaranjan S, Sharma R, Deary A, Edwards A, Green L, Wade CE, Benger JR, Cotton BA, Stanworth SJ, Brohi K; CRYOSTAT-2 Principal Investigators. Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1882-1891. doi: 10.1001/jama.2023.21019.
PubMed 37824155Curry N, Rourke C, Davenport R, Beer S, Pankhurst L, Deary A, Thomas H, Llewelyn C, Green L, Doughty H, Nordmann G, Brohi K, Stanworth S. Early cryoprecipitate for major haemorrhage in trauma: a randomised controlled feasibility trial. Br J Anaesth. 2015 Jul;115(1):76-83. doi: 10.1093/bja/aev134. Epub 2015 May 19.
PubMed 25991760McQuilten ZK, Bailey M, Cameron PA, Stanworth SJ, Venardos K, Wood EM, Cooper DJ. Fibrinogen concentration and use of fibrinogen supplementation with cryoprecipitate in patients with critical bleeding receiving massive transfusion: a bi-national cohort study. Br J Haematol. 2017 Oct;179(1):131-141. doi: 10.1111/bjh.14804. Epub 2017 Jun 27.
PubMed 28653339Holcomb JB, del Junco DJ, Fox EE, Wade CE, Cohen MJ, Schreiber MA, Alarcon LH, Bai Y, Brasel KJ, Bulger EM, Cotton BA, Matijevic N, Muskat P, Myers JG, Phelan HA, White CE, Zhang J, Rahbar MH; PROMMTT Study Group. The prospective, observational, multicenter, major trauma transfusion (PROMMTT) study: comparative effectiveness of a time-varying treatment with competing risks. JAMA Surg. 2013 Feb;148(2):127-36. doi: 10.1001/2013.jamasurg.387.
PubMed 23560283
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryo-FIRST: Cryoprecipitate For Immediate Resuscitation in Severe Trauma: Effectiveness of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) for Treatment of Trauma Associated Hemorrhage
- ClinicalTrials.gov ID
- NCT07218185
- Acronym / sponsor ID
- CRYO-FIRST / CLI 00193
- Keywords
- Fibrinogen, Hemorrhage, Trauma, Resuscitation, INTERCEPT Fibrinogen Complex, Pathogen Reduced Cryoprecipitated Fibrinogen Complex, Hemorrhagic Shock, Quantra
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Cerus CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Coalition for National Trauma Research
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) in trauma patients with hemorrhagic shock (HS) and functional hypofibrinogenemia. This study will determine whether rapid point-of-care testing for functional hypofibrinogenemia and availability of a shelf-stable fibrinogen complex (IFC) results in shorter time to administration of fibrinogen replacement and correction of functional hypofibrinogenemia, as compared with historical controls and published literature using conventional cryoprecipitate-AHF (CRYO-AHF).
This study aims to:
- Demonstrate the feasibility and response to early administration of pre-thawed IFC when ordered during initial resuscitation of severely injured patients with HS and functional hypofibrinogenemia.
- Assess the effectiveness of early administration of pre-thawed IFC on correction of functional hypofibrinogenemia and on proximate process measures of resuscitation, including time to hemostasis, time to completion of resuscitation, and total volume of resuscitation.
- Assess clinical outcomes in severely injured patients with HS and functional hypofibrinogenemia receiving early administration of pre-thawed IFC.
Detailed description
This is a multicenter, pragmatic, observational, single-arm study evaluating the feasibility and effectiveness of early administration of pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) in trauma patients with hemorrhagic shock and functional hypofibrinogenemia.
Adult trauma patients age ≥18 years, or estimated weight ≥50 kg if age is unknown, who present to a participating trauma center within 1 hour of estimated time of injury and meet criteria for hemorrhagic shock will be screened using the point-of-care Quantra® Hemostasis Analyzer. Functional hypofibrinogenemia is defined as FCS <1.6 hPa by Quantra® point-of-care testing. Patients are eligible only if cryoprecipitate administration is clinically indicated by the treating physician, IFC is available at the time of enrollment, and the patient will receive IFC per standard of care.
Following administration of IFC, an additional Quantra® point-of-care test will be completed at completion of resuscitation (COR), defined as discontinuation of the massive transfusion protocol (MTP), to evaluate fibrinogen response. Additional IFC may be administered if additional hemostatic correction is determined to be needed by the treating clinician, repeat point-of-care testing, or clinical judgment.
Primary outcomes are the proportion of patients with hemorrhagic shock and functional hypofibrinogenemia who receive IFC within 60 minutes of presentation to the participating trauma center and the proportion of patients with successful correction of functional hypofibrinogenemia at COR. Secondary outcomes include time to hemostasis, estimated blood loss, transfusion burden/total volume of resuscitation, mortality at 3 hours, 6 hours, 24 hours, and 30 days or in-hospital mortality, and adverse clinical outcomes through 30 days, hospital discharge, or death, whichever occurs first. Outcomes may be compared descriptively with historical controls, site medical databases, and published literature using CRYO-AHF.
Four Level 1 trauma centers will enroll approximately 320 patients over approximately 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IFC arm | – | Biological: Pathogen Reduced Cryoprecipitated Fibrinogen ComplexSubjects will receive Pathogen Reduced Cryoprecipitated Fibrinogen Complex (IFC) for fibrinogen supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female trauma patients, age ≥18 years or estimated weight ≥50 kg if age is unknown, with evidence of hemorrhagic shock and functional hypofibrinogenemia by admission point-of-care testing, admitted to a participating trauma center within 1 hour of sustaining injury.
Key inclusion criteria (10 listed)
- Traumatic injury
- Age ≥18 years or estimated weight ≥50 kg, if age unknown
- Presenting to a participating trauma center ≤1 hour from estimated time of injury
- Functional hypofibrinogenemia upon arrival to the trauma center as measured by point-of-care testing (Quantra®) with FCS <1.6 hPa
- Hemorrhagic shock, defined as:
Key exclusion criteria (9 listed)
- Suspected isolated severe brain or spinal cord injury
- Isolated drowning or hanging
- Burns >20% total body surface area (TBSA)
- Known pregnancy
- Admitted from a correctional facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathogen Reduced Cryoprecipitated Fibrinogen ComplexAlso: INTERCEPT Fibrinogen Complex, IFCPre-thawed IFC will be administered per standard of care when cryoprecipitate administration is clinically indicated by the treating physician and IFC is available. Participants must have functional hypofibrinogenemia by Quantra® POC testing with FCS <1.6 hPA. Additional IFC may be administered based on repeat POC testing or clinical judgment. | Biological | IFC arm |
Primary outcome
IFC administration within 60 minutes of presentation
Time frame: From presentation/admission to the participating trauma center to initial IFC transfusion, assessed up to 60 minutes after presentation.
Proportion (%) of patients with hemorrhagic shock and functional hypofibrinogenemia who receive IFC within 60 minutes of presentation to the participating trauma center.
Correction of functional hypofibrinogenemia after IFC transfusion
Time frame: At completion of resuscitation (COR), defined as discontinuation of the massive transfusion protocol (MTP), after IFC transfusion.
Proportion of patients with successful correction of functional fibrinogen, defined as FCS ≥1.6 hPa by Quantra® point-of-care testing after transfusion of IFC, measured at completion of resuscitation (COR).
2 secondary outcomes
Mortality
Time frame: 3, 6, and 24 hours after admission/enrollment; 30 days or in-hospital mortality.
Clinical complications/adverse clinical outcomes.
Time frame: From enrollment through 30 days, hospital discharge, or death, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Background: PubMed 37164268Rossetto A, Wohlgemut JM, Brohi K, Davenport R. Sonorheometry versus rotational thromboelastometry in trauma: a comparison of diagnostic and prognostic performance. J Thromb Haemost. 2023 Aug;21(8):2114-2125. doi: 10.1016/j.jtha.2023.04.031. Epub 2023 May 8.
- BackgroundHuffman G, Wilken N, Loh JH, Fazal M, Lei I, Myers A, et al. Analysis of Wastage, Savings, and Maternal and Pediatric Outcomes for Pooled Pathogen Reduced Cryoprecipitate versus Conventional Cryoprecipitate. Baylor College of Medicine; Abstract AABB Annual Meeting. 2024.
- Background: PubMed 25647203Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.
- Background: PubMed 37824155Davenport R, Curry N, Fox EE, Thomas H, Lucas J, Evans A, Shanmugaranjan S, Sharma R, Deary A, Edwards A, Green L, Wade CE, Benger JR, Cotton BA, Stanworth SJ, Brohi K; CRYOSTAT-2 Principal Investigators. Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1882-1891. doi: 10.1001/jama.2023.21019.
- Background: PubMed 25991760Curry N, Rourke C, Davenport R, Beer S, Pankhurst L, Deary A, Thomas H, Llewelyn C, Green L, Doughty H, Nordmann G, Brohi K, Stanworth S. Early cryoprecipitate for major haemorrhage in trauma: a randomised controlled feasibility trial. Br J Anaesth. 2015 Jul;115(1):76-83. doi: 10.1093/bja/aev134. Epub 2015 May 19.
- Background: PubMed 28653339McQuilten ZK, Bailey M, Cameron PA, Stanworth SJ, Venardos K, Wood EM, Cooper DJ. Fibrinogen concentration and use of fibrinogen supplementation with cryoprecipitate in patients with critical bleeding receiving massive transfusion: a bi-national cohort study. Br J Haematol. 2017 Oct;179(1):131-141. doi: 10.1111/bjh.14804. Epub 2017 Jun 27.
- Background: PubMed 23560283Holcomb JB, del Junco DJ, Fox EE, Wade CE, Cohen MJ, Schreiber MA, Alarcon LH, Bai Y, Brasel KJ, Bulger EM, Cotton BA, Matijevic N, Muskat P, Myers JG, Phelan HA, White CE, Zhang J, Rahbar MH; PROMMTT Study Group. The prospective, observational, multicenter, major trauma transfusion (PROMMTT) study: comparative effectiveness of a time-varying treatment with competing risks. JAMA Surg. 2013 Feb;148(2):127-36. doi: 10.1001/2013.jamasurg.387.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypofibrinogenemia and Hemorrhage, run by Cerus Corporation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IFC administration within 60 minutes of presentation (time frame: From presentation/admission to the participating trauma center to initial IFC transfusion, assessed up to 60 minutes after presentation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07218185, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.