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New blood treatment could save trauma patients faster

NCT ID NCT07218185

Disease control Sponsor: Cerus Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new shelf-stable blood product (IFC) works faster than the standard cryoprecipitate to stop severe bleeding in trauma patients. About 320 adults with traumatic injuries and low fibrinogen levels will be enrolled. The goal is to see if IFC can be given more quickly and correct bleeding problems sooner, potentially improving survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult male and female trauma patients, age ≥18 years or estimated weight ≥50 kg if age is unknown, with evidence of hemorrhagic shock and functional hypofibrinogenemia by admission point-of-care testing, admitted to a participating trauma center within 1 hour of sustaining injury.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

congenital afibrinogenemia familial dysfibrinogenemia familial hypofibrinogenemia Hemorrhage injury Shock, Hemorrhagic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemorrhage Hemorrhagic shock Hypofibrinogenemia Trauma associated hemorrhage

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anschutz Medical Center, University of Colorado

    Aurora, Colorado, 80045, United States

  • Barnes Jewish Hospital, Washington University of Saint Louis

    St Louis, Missouri, 63110, United States

  • R Adams Cowley Shock Trauma Center, University of Maryland

    Baltimore, Maryland, 21201, United States

  • Ryder Trauma Center/Jackson Memorial Hospital, University of Miami

    Miami, Florida, 33136, United States

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