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NCT07218185 · ClinicalTrials.gov registry record
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
A clinical trial, sponsored by Cerus Corporation.
- Not yet
- Registry status
- 320
- Enrollment target
NCT07218185: Clinical Trial study, sponsored by Cerus Corporation.
NCT07218185 is a clinical trial that has not yet begun recruiting, run by Cerus Corporation. The registered enrollment target is 320 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07218185 has not yet begun recruiting, sponsored by Cerus Corporation.
- NOT YET RECRUITING
- Registry status
- 320 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Proportion (%) of patients with hemorrhagic shock and functional hypofibrinogenemia who receive IFC within 60 minutes of presentation to the participating trauma center.
Interventions
- BIOLOGICAL Pathogen Reduced Cryoprecipitated Fibrinogen Complex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2026-07 |
| Est. Completion | 2028-08 |
What is known before NCT07218185 opens enrollment
NCT07218185 is an observational study that tracks outcomes without assigning an intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Pathogen Reduced Cryoprecipitated Fibrinogen Complex is the first listed.
NCT07218185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07218185 about?
NCT07218185 is a clinical study titled "Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage". 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 ...
What is the current status of trial NCT07218185?
This trial is currently not yet recruiting. The enrollment target is 320 participants. The study started on 2026-07. Estimated completion is 2028-08.
What interventions are being tested in trial NCT07218185?
The interventions under investigation include: Pathogen Reduced Cryoprecipitated Fibrinogen Complex (BIOLOGICAL).
Who is sponsoring clinical trial NCT07218185?
This trial is sponsored by Cerus Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
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