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Cryo-FIRST: INTERCEPT Fibrinogen Complex for Trauma Bleeding

This study is looking at how well and how quickly a treatment called INTERCEPT Fibrinogen Complex (IFC) works for people who have severe bleeding (hemorrhage) after a traumatic injury. IFC is a special blood product that helps your blood clot. The study focuses on patients who also have low levels of a clotting protein called fibrinogen (hypofibrinogenemia), which is measured by a quick test called Quantra® at the hospital. Doctors will give IFC if it's needed and available. The main goals are to see if IFC can be given within 60 minutes of arriving at the hospital and if it helps correct low fibrinogen levels by the end of resuscitation. This is an observational study, meaning doctors will be watching how patients respond to IFC as part of their usual care. About 320 adults with traumatic injury and low fibrinogen are expected to participate.

Study design
This is an observational study involving about 320 participants. It is a single-arm study, meaning all participants will receive the INTERCEPT Fibrinogen Complex if it's indicated and available.
What's involved
You would receive INTERCEPT Fibrinogen Complex as part of your standard care if your doctor determines it's needed and available. Your fibrinogen levels will be tested with Quantra® upon arrival and again after resuscitation.
Compensation
Not stated in the trial record.
Follow-up
Your fibrinogen levels will be measured at the completion of resuscitation, which is when the massive transfusion protocol is stopped.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07218185

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

Not Yet Recruiting
Not specifiedAges 18+Observational
Cerus Corporation
~320 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Pathogen Reduced Cryoprecipitated Fibrinogen Complex

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
IFC administration within 60 minutes of presentation
Measured over From presentation/admission to the participating trauma center to initial IFC transfusion, assessed up to 60 minutes after presentation.
+1 more outcome measured

Conditions

Hypofibrinogenemia
Hemorrhage
Trauma Associated Hemorrhage
Hemorrhagic Shock

Explore related trials

Factor I DeficiencyHemorrhagic ShockInjuryFibrinogen

Where it's being run

4 sites across 4 states
Colorado1
Florida1
Maryland1
Missouri1

Who to contact

Laurence Corash, MD
[email protected]
925-288-6118
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
IFC administration is clinically indicated per the treating physician
IFC is available at the time of enrollment

Exclusion

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

What this trial measures

  • IFC administration within 60 minutes of presentationFrom 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 transfusionAt 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).