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

Starting soon

Conditions studied: Hypofibrinogenemia, Hemorrhage, Trauma Associated Hemorrhage, Hemorrhagic Shock

In brief

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.

Key facts

Study ID

NCT07218185

Run by

Cerus Corporation

People needed

320

Starts

2026-07-01

Expected to finish

2028-08-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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