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
Cerus Corporation
Summary
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.
Description
This study is a multicenter, multi-period, by hospital cluster randomized, alternating treatment block crossover study comparing pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) to Cryoprecipitate-AHF (Cryo-AHF) in patients with hemorrhagic shock and functional hypofibrinogenemia. This study will assess the feasibility and effectiveness of early IFC administration in trauma patients in hemorrhagic shock with functional hypofibrinogenemia. Specifically, it aims to determine whether IFC enables faster delivery of fibrinogen replacement compared…
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 participating trauma center ≤1 hour from estimated time of injury * Functional hypofibrinogenemia upon arrival to the trauma center as measured by POC testing (Quantra) with an FCS \< 1.6 hPa * Hemorrhagic shock defined as: 1. Initiation of transfusion of any uncross matched blood product AND 2. Evidence of active hemorrhage as judged by the attending trauma surgeon AND 3. Initiation of the participating trauma center's MTP * IFC or CRYO-AHF are available at the time of en…
Interventions
- BiologicalPathogen Reduced Cryoprecipitated Fibrinogen Complex
IFC will be administered based on the study site's assigned treatment block. Study subjects will receive IFC with a point-of-care testing value of FCS \<1.6 hPa. Additional IFC may be administered per point-of-care testing or clinical judgement, as needed.
- BiologicalCryoprecipitated-Antihemophilic Factor
Cryo-AHF will be administered based on the study site's assigned treatment block. Study subjects will receive Cryo-AHF with a point-of-care testing value of FCS \<1.6 hPa. Additional Cryo-AHF may be administered per point-of-care testing or clinical judgement, as needed.
Locations (4)
- University of Colorado, Anschutz Medical CenterAurora, Colorado
- Jackson Memorial Hospital, University of MiamiMiami, Florida
- University of Maryland School of MedicineBaltimore, Maryland
- Barnes-Jewish Hospital, Washington University of Saint LouisSt Louis, Missouri