Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage

NCT07218185 | Not Yet Recruiting FDA Drug

• 1 other identifier: CLI 00193
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 4

Brief 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 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.

Conditions

Hypofibrinogenemia; Hemorrhage; Trauma Associated Hemorrhage; Hemorrhagic Shock

Keywords

Fibrinogen; Hemorrhage; Trauma; Resuscitation; INTERCEPT Fibrinogen Complex; Pathogen Reduced Cryoprecipitated Fibrinogen Complex; Hemorrhagic Shock; Quantra

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  At completion of resuscitation (COR), defined as discontinuation of the massive transfusion protocol (MTP), after IFC transfusion.

Secondary Outcomes (2)

• Mortality

  3, 6, and 24 hours after admission/enrollment; 30 days or in-hospital mortality.

• Clinical complications/adverse clinical outcomes.

  From enrollment through 30 days, hospital discharge, or death, whichever occurs first.

Other Outcomes (3)

• Time to hemostasis (TTH)

  From presentation/admission to hemostasis.

• Time to Completion of Resuscitation (COR)

  From presentation/admission to the participating trauma center to discontinuation of MTP.

• Total volume of resuscitation (TVOR)

  From arrival/presentation through 24 hours after admission; also summarized from arrival to COR and from COR to 24 hours.

Study Arms (1)

IFC arm

Subjects will receive Pathogen Reduced Cryoprecipitated Fibrinogen Complex (IFC) for fibrinogen supplementation.

Biological: Pathogen Reduced Cryoprecipitated Fibrinogen Complex

Interventions

Pathogen Reduced Cryoprecipitated Fibrinogen Complex BIOLOGICAL

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.

Also known as: INTERCEPT Fibrinogen Complex, IFC

IFC arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Cerus Corporation: lead
• Coalition for National Trauma Research: collaborator

Study Sites (4)

Anschutz Medical Center, University of Colorado

Aurora, Colorado, 80045, United States

Location

Ryder Trauma Center/Jackson Memorial Hospital, University of Miami

Miami, Florida, 33136, United States

Location

R Adams Cowley Shock Trauma Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Barnes Jewish Hospital, Washington University of Saint Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (7)

• 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.

  PMID: 37164268 BACKGROUND

• Huffman 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

• 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.

  PMID: 25647203 BACKGROUND

• Davenport 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.

  PMID: 37824155 BACKGROUND

• Curry 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.

  PMID: 25991760 BACKGROUND

• McQuilten 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.

  PMID: 28653339 BACKGROUND

• Holcomb 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.

  PMID: 23560283 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma from waste blood, if available, collected from admission and/or post-infusion draws for subsequent coagulation and biologic analyses.

MeSH Terms

Conditions

Afibrinogenemia; Hemorrhage; Shock, Hemorrhagic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Laurence Corash, MD

CONTACT

925-288-6118; lcorash@cerus.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 20, 2025
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (4)