Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
← catalyst calendarNCT07218185 · readout ≤ 712 d
Sponsored by Cerus Corporation (industry) · CERS — their whole pipeline →. With Coalition for National Trauma Research.
Phase
—
Status
Not yet recruiting
Study type
Observational
Enrollment
320estimated
Sites
4
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Jul 2026 | estimated | When the study began enrolling |
| Primary completion | Jul 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-10-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Hypofibrinogenemia
- Hemorrhage
- Trauma Associated Hemorrhage
- Hemorrhagic Shock
Intervention
- Biological: Pathogen Reduced Cryoprecipitated Fibrinogen Complex — also filed as INTERCEPT Fibrinogen Complex, IFC
Primary outcomes
what the primary-completion date above is the date OFIFC administration within 60 minutes of presentation
measured From presentation/admission to the participating trauma center to initial IFC transfusion, assessed up to 60 minutes after presentation.
Correction of functional hypofibrinogenemia after IFC transfusion
measured At completion of resuscitation (COR), defined as discontinuation of the massive transfusion protocol (MTP), after IFC transfusion.
Publications
- PMID 37164268 — cited as background
- PMID 25647203 — cited as background
- PMID 37824155 — cited as background
- PMID 25991760 — cited as background
- PMID 28653339 — cited as background
- PMID 23560283 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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