Cryo-FIRST: Cryoprecipitate For Immediate Resuscitation in Severe Trauma: Effectiveness of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) for Treatment of Trauma Associated Hemorrhage
Cerus Corporation
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.
Description
This is a multicenter, pragmatic, observational, single-arm study evaluating the feasibility and effectiveness of early administration of pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) in trauma patients with hemorrhagic shock and functional hypofibrinogenemia. Adult trauma patients age ≥18 years, or estimated weight ≥50 kg if age is unknown, who present to a participating trauma center within 1 hour of estimated time of injury and meet criteria for hemorrhagic shock will be screened using the point-of-care Quantra® Hemostasis Analyzer. Fun…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 admini…
Interventions
- BiologicalPathogen Reduced Cryoprecipitated Fibrinogen Complex
Pre-thawed IFC will be administered per standard of care when cryoprecipitate administration is clinically indicated by the treating physician and IFC is available. Participants must have functional hypofibrinogenemia by Quantra® POC testing with FCS \<1.6 hPA. Additional IFC may be administered based on repeat POC testing or clinical judgment.
Locations (4)
- Anschutz Medical Center, University of ColoradoAurora, Colorado
- Ryder Trauma Center/Jackson Memorial Hospital, University of MiamiMiami, Florida
- R Adams Cowley Shock Trauma Center, University of MarylandBaltimore, Maryland
- Barnes Jewish Hospital, Washington University of Saint LouisSt Louis, Missouri