EICHORCondition: Hypofibrinogenemia · Hemorrhage · Trauma Associated Hemorrhage · Sponsor: Cerus Corporation
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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.
This description comes directly from the study's public registry record.
Laurence Corash, MD · 925-288-6118 · lcorash@cerus.com
Always discuss trial participation with your own doctor first.
| Anschutz Medical Center, University of Colorado | Aurora, Colorado, United States | — |
| Ryder Trauma Center/Jackson Memorial Hospital, University of Miami | Miami, Florida, United States | — |
| R Adams Cowley Shock Trauma Center, University of Maryland | Baltimore, Maryland, United States | — |
| Barnes Jewish Hospital, Washington University of Saint Louis | St Louis, Missouri, United States | — |
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Source record: clinicaltrials.gov/study/NCT07218185