Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage

ConditionsHypofibrinogenemia Hemorrhage Trauma Associated Hemorrhage Hemorrhagic Shock

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorCerus Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Suspected isolated severe brain or spinal cord injury

Isolated drowning or hanging

Burns >20% total body surface area (TBSA)

Known pregnancy

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Pathogen Reduced Cryoprecipitated Fibrinogen Complex
Biological/Vaccine
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.

Treatment groups

320 Participants

are divided into 1 treatment group

Group A: IFC arm1 intervention

Trial outcomes

Primary outcomes

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.

Secondary outcomes

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.

Other outcomes

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cerus Corporation

Lead sponsor

Coalition for National Trauma Research

Collaborator

Source ClinicalTrials.gov

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