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

NCT07218185 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2025-10-17

No results posted yet for this study

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

Interventions

BIOLOGICAL

Pathogen Reduced Cryoprecipitated Fibrinogen Complex

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.

BIOLOGICAL

Cryoprecipitated-Antihemophilic Factor

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.

Sponsors & Collaborators

  • Coalition for National Trauma Research

    collaborator OTHER

  • Cerus Corporation

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-02-29
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07218185 on ClinicalTrials.gov