Comparative Effectiveness of INTERCEPT Fibrinogen Complex (IFC) and Cryoprecipitate-AHF (Cryo-AHF) for Treatment of Trauma Associated Hemorrhage

NCT07218185 | Not Yet Recruiting DMC FDA Drug

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

Brief Summary

The objective of this study is to determine the feasibility and effectiveness of early IFC administration in patients with functional hypofibrinogenemia associated with hemorrhagic shock (HS). This study will elucidate whether advancements in rapid testing for functional hypofibrinogenemia and provision of a shelf-stable fibrinogen complex (IFC) results in a shorter time to administration of fibrinogen replacement, thus overcoming the limitations encountered by prior trials. This study aims to:

• Demonstrate the feasibility and response to early administration of pre-thawed IFC compared to CRYO-AHF when ordered during resuscitation of severely injured patients with HS and functional hypofibrinogenemia.
• Assess effectiveness of early administration of pre-thawed IFC vs CRYO-AHF in severely injured patients with HS and functional hypofibrinogenemia on proximate process measures of resuscitation.
• Assess clinical outcomes in severely injured patients with HS and functional hypofibrinogenemia receiving early administration of pre-thawed IFC vs CRYO-AHF product.

Conditions

Hypofibrinogenemia; Hemorrhage

Keywords

Fibrinogen; Hemorrhage; Trauma; Resuscitation

Outcome Measures

Primary Outcomes (2)

• Correction of functional fibrinogen

  The correction of functional fibrinogen as measured by point-of-care testing (Quantra) after transfusion of IFC or CRYO-AHF, as measured at completion of resuscitation. The time to correction of functional fibrinogen is reported in hours and minutes.

  From time of initiation of anesthesia until time of completion of resuscitation.

• The proportion (%) of patients who receive IFC or Cryo-AHF within 60 minutes of presentation to the participating trauma center.

  The proportion (%) of patients with hemorrhagic shock who have functional hypofibrinogenemia and who receive IFC or Cryo-AHF within 60 minutes of presentation to the participating trauma center.

  From time of admission to the hospital trauma service to initial transfusion of either IFC or Cryo-AHF, measured in hours and minutes.

Secondary Outcomes (2)

• Mortality rates

  Measured from the time of admission to the hospital trauma service until death. Measured at 3, 6, and 24 hours after admission and reported in hours. Beyond 24 hours and up to 30 days post-admission, mortality is measured and reported in days.

• Clinical complications

  Within 24 hours of treatment.

Other Outcomes (3)

• Time to hemostasis (TTH)

  From time of admission to the trauma service until either hospital day 30, day of discharge, or death, whichever comes first, for a maximum of 30 days.

• Time to Completion of Resuscitation (COR)

  From time of initiation of the MTP by the trauma service (measured in hours and minutes) until discontinuation of the MTP until either hospital day 30, day of discharge or death, whichever comes first, for a maximum of 30 days.

• Total volume of resuscitation (TVOR)

  From time of admission to the hospital trauma service, measured at 24 hours after admission, and measured at COR at either hospital day 30, day of discharge, or death, whichever comes first, for a maximum of 30 days.

Study Arms (2)

IFC arm

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

Biological: Pathogen Reduced Cryoprecipitated Fibrinogen Complex

Cryo AHF arm

Subjects will receive Cryoprecipitated-Antihemophilic Factor (Cryo-AHF) for fibrinogen supplementation.

Biological: Cryoprecipitated-Antihemophilic Factor

Interventions

Pathogen Reduced Cryoprecipitated Fibrinogen Complex BIOLOGICAL

IFC will be administered based on the study site's assigned treatment block. Study subjects will receive IFC with a point-of-care testing value of FCS \<1.6 hPa. Additional IFC may be administered per point-of-care testing or clinical judgement, as needed.

Also known as: INTERCEPT Fibrinogen Complex, IFC

IFC arm

Cryoprecipitated-Antihemophilic Factor BIOLOGICAL

Cryo-AHF will be administered based on the study site's assigned treatment block. Study subjects will receive Cryo-AHF with a point-of-care testing value of FCS \<1.6 hPa. Additional Cryo-AHF may be administered per point-of-care testing or clinical judgement, as needed.

Also known as: Cryo-AHF, Cryoprecipitate-AHF, Cryo

Cryo AHF 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

Hemorrhagic trauma

You may qualify if:

• Traumatic injury
• Age ≥18 years or estimated weight ≥ 50 kg, if age unknown
• Presenting to participating trauma center ≤1 hour from estimated time of injury
• Functional hypofibrinogenemia upon arrival to the trauma center as measured by POC testing (Quantra) with an FCS \< 1.6 hPa
• Hemorrhagic shock defined as:
• Initiation of transfusion of any uncross matched blood product AND
• Evidence of active hemorrhage as judged by the attending trauma surgeon AND
• Initiation of the participating trauma center's MTP
• IFC or CRYO-AHF are 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
• Isolated fall from standing
• Emergency Department (ED) thoracotomy

Sponsors & Collaborators

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

Study Sites (4)

University of Colorado, Anschutz Medical Center

Aurora, Colorado, 80045, United States

Location

Jackson Memorial Hospital, University of Miami

Miami, Florida, 33136, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21021, 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 RESULT

• 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.

  RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Afibrinogenemia; Hemorrhage; 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

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: May 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (4)