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

NCT07218185 · tracked via the Priya Life Science USA tracker

Sponsor

Cerus Corporation

Phase

Observational

Started

2026-09-15

Last updated

2026-10-14

Condition(s) studied

HypofibrinogenemiaHemorrhageTrauma Associated HemorrhageHemorrhagic Shock

Investigational drug(s) / intervention(s)

Pathogen Reduced Cryoprecipitated Fibrinogen Complex

Pathogen Reduced Cryoprecipitated Fibrinogen Complex: 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 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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: 1. Initiation of transfusion of any uncrossmatched blood product; 2. Evidence of active hemorrhage as judged by the attending trauma surgeon; and 3. 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 Exclusion Criteria: * 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

Primary outcome measure(s)

IFC administration within 60 minutes of presentation — 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 — 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).

Trial sites (4)

Facility	City	Region
Anschutz Medical Center, University of Colorado	Aurora	Colorado
Ryder Trauma Center/Jackson Memorial Hospital, University of Miami	Miami	Florida
R Adams Cowley Shock Trauma Center, University of Maryland	Baltimore	Maryland
Barnes Jewish Hospital, Washington University of Saint Louis	St Louis	Missouri

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Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Antibodies to INTERCEPT RBCs Starting soon

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07218185 on ClinicalTrials.gov ↗ ← All trials in the USA