An observational study in Hypofibrinogenemia, Hemorrhage and Trauma Associated Hemorrhage, sponsored by Cerus Corporation. Enrolling by invitation at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Cerus Corporation · Observational
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:
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. Functional hypofibrinogenemia is defined as FCS \<1.6 hPa by Quantra® point-of-care testing. Patients are eligible only if cryoprecipitate administration is clinically indicated by the treating physician, IFC is available at the time of enrollment, and the patient will receive IFC per standard of care.
Following administration of IFC, an additional Quantra® point-of-care test will be completed at completion of resuscitation (COR), defined as discontinuation of the massive transfusion protocol (MTP), to evaluate fibrinogen response. Additional IFC may be administered if additional hemostatic correction is determined to be needed by the treating clinician, repeat point-of-care testing, or clinical judgment.
Primary outcomes are the proportion of patients with hemorrhagic shock and functional hypofibrinogenemia who receive IFC within 60 minutes of presentation to the participating trauma center and the proportion of patients with successful correction of functional hypofibrinogenemia at COR. Secondary outcomes include time to hemostasis, estimated blood loss, transfusion burden/total volume of resuscitation, mortality at 3 hours, 6 hours, 24 hours, and 30 days or in-hospital mortality, and adverse clinical outcomes through 30 days, hospital discharge, or death, whichever occurs first. Outcomes may be compared descriptively with historical controls, site medical databases, and published literature using CRYO-AHF.
Four Level 1 trauma centers will enroll approximately 320 patients over approximately 24 months.
32 studies on the registry are indexed under Afibrinogenemia; 5 are open to participants now.
This study's planned enrollment of 320 is above the median of 150 across 11 observational studies indexed under Afibrinogenemia.
Browse Afibrinogenemia studies →Cerus Corporation is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult male and female trauma patients, age ≥18 years or estimated weight ≥50 kg if age is unknown, with evidence of hemorrhagic shock and functional hypofibrinogenemia by admission point-of-care testing, admitted to a participating trauma center within 1 hour of sustaining injury.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Hemorrhagic shock, defined as:
Exclusion Criteria:
Subjects will receive Pathogen Reduced Cryoprecipitated Fibrinogen Complex (IFC) for fibrinogen supplementation.
Biological: Pathogen 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.
Also known as: INTERCEPT Fibrinogen Complex, IFC
IFC administration within 60 minutes of presentation
Proportion (%) of patients with hemorrhagic shock and functional hypofibrinogenemia who receive IFC within 60 minutes of presentation to the participating trauma center.
Time frame: From presentation/admission to the participating trauma center to initial IFC transfusion, assessed up to 60 minutes after presentation.
Correction of functional hypofibrinogenemia after IFC transfusion
Proportion of patients with successful correction of functional fibrinogen, defined as FCS ≥1.6 hPa by Quantra® point-of-care testing after transfusion of IFC, measured at completion of resuscitation (COR).
Time frame: At completion of resuscitation (COR), defined as discontinuation of the massive transfusion protocol (MTP), after IFC transfusion.
Mortality
Mortality incidence at 3 hours, 6 hours, 24 hours, and 30 days or in-hospital mortality.
Time frame: 3, 6, and 24 hours after admission/enrollment; 30 days or in-hospital mortality.
Clinical complications/adverse clinical outcomes.
Incidences of acute blood loss anemia, abdominal compartment syndrome, acute kidney injury, acute renal failure, acute respiratory distress syndrome, bleeding after hemostasis requiring intervention, coagulopathy, febrile non-hemolytic transfusion reaction, hospital-acquired pneumonia, intraabdominal infection, liver failure, MOD, MOF, myocardial infarction, sepsis, stroke, surgical site infection, symptomatic and asymptomatic deep vein thrombosis, symptomatic and asymptomatic pulmonary embolism, systemic inflammatory response syndrome, transfusion-associated circulatory overload (TACO), transfusion-associated lung injury (TRALI), transfusion-related allergic reactions, transfusion-related hyperkalemia in the first 24 hours, transfusion-related hypocalcemia in the first 24 hours, and ventilator-associated pneumonia.
Time frame: From enrollment through 30 days, hospital discharge, or death, whichever occurs first.
Time to hemostasis (TTH)
Time to hemostasis, defined as when the surgeon determines bleeding is considered controlled in the surgical field, or at least one hour without transfusion in patients not undergoing a bleeding control intervention.
Time frame: From presentation/admission to hemostasis.
Time to Completion of Resuscitation (COR)
Time to completion of resuscitation, defined as discontinuation of the massive transfusion protocol (MTP).
Time frame: From presentation/admission to the participating trauma center to discontinuation of MTP.
Total volume of resuscitation (TVOR)
Total volume of resuscitation/blood products; TVOR in the first 24 hours is the primary endpoint of this sub-aim, with volume also determined from arrival to COR and from COR to 24 hours.
Time frame: From arrival/presentation through 24 hours after admission; also summarized from arrival to COR and from COR to 24 hours.
Started Sep 2026 (actual). Primary completion is estimated for Jul 2028, 22 months after the start.
Start moved once since we started tracking on Sep 25, 2026: Jul 2026 → Sep 2026, on Oct 14, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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