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NCT07218185: CRYO-FIRST
Comparative Effectiveness of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) and Cryoprecipitate-AHF (Cryo-AHF) for Treatment of Trauma Associated Hemorrhage: CRYO-FIRST, A Quality Improvement Study
trial testing Pathogen Reduced Cryoprecipitated Fibrinogen Complex in Hypofibrinogenemia in 320 participants. Not yet recruiting.
1 February 2028
Quick facts
| Lead sponsor | Cerus Corporation |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 320 |
| Start date | 1 May 2026 |
| Primary completion | 1 February 2028 |
| Estimated completion | 1 August 2028 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Pathogen Reduced Cryoprecipitated Fibrinogen Complex — full drug profile →
- Cryoprecipitated-Antihemophilic Factor — full drug profile →
Conditions studied
- Hypofibrinogenemia — all drugs for Hypofibrinogenemia →
- Hemorrhage — all drugs for Hemorrhage →
Sponsor
Cerus Corporation — full company profile →
Who can join
18 and older, any sex, with Hypofibrinogenemia or Hemorrhage. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Correction of functional fibrinogen
Time frame: From time of initiation of anesthesia until time of completion of resuscitation.
The correction of functional fibrinogen as measured by point-of-care testing (Quantra) after transfusion of IFC or CRYO-AHF, as measured at completion of resuscitation. The time to correction of functional fibrinogen is reported in hours and minutes. -
The proportion (%) of patients who receive IFC or Cryo-AHF within 60 minutes of presentation to the participating trauma center.
Time frame: From time of admission to the hospital trauma service to initial transfusion of either IFC or Cryo-AHF, measured in hours and minutes.
The proportion (%) of patients with hemorrhagic shock who have functional hypofibrinogenemia and who receive IFC or Cryo-AHF within 60 minutes of presentation to the participating trauma center.
Sponsor's own description
The objective of this study is to determine the feasibility and effectiveness of early IFC administration in patients with functional hypofibrinogenemia associated with hemorrhagic shock (HS). This study will elucidate whether advancements in rapid testing for functional hypofibrinogenemia and provision of a shelf-stable fibrinogen complex (IFC) results in a shorter time to administration of fibrinogen replacement, thus overcoming the limitations encountered by prior trials. This study aims to: * Demonstrate the feasibility and response to early administration of pre-thawed IFC compared to CRYO-AHF when ordered during resuscitation of severely injured patients with HS and functional hypofibrinogenemia. * Assess effectiveness of early administration of pre-thawed IFC vs CRYO-AHF in severely injured patients with HS and functional hypofibrinogenemia on proximate process measures of resuscitation. * Assess clinical outcomes in severely injured patients with HS and functional hypofibrinogenemia receiving early administration of pre-thawed IFC vs CRYO-AHF product.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07218185
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypofibrinogenemia
Currently open trials in the same condition.
- NCT06434389 — A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery · recruiting
Other Cerus Corporation trials
Trials by the same sponsor.
- NCT07152379 — Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Anti · Phase 2 · not yet recruiting
- NCT07155031 — Biotin-Acridine Red Cell Exchange Kinetics · Phase 2 · withdrawn
- NCT07015437 — A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS · Phase 2 · recruiting
- NCT06697223 — A Study to Assess Recovery and Survival of Radiolabeled Apheresis Platelet Components Treated With the INTERCEPT Blood S · Phase 2 · completed
- NCT04022889 — In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Sus · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07218185 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cerus Corporation
- Last refreshed: 15 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07218185.
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