Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy

Study Overview
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Brief Summary
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Phase 2a study to assess the safety and efficacy of IV infused spray-dried solvent/detergent -treated plasma (Resusix) when compared with an equal volume of plasma frozen within 24 hours after phlebotomy (FP24) in patients with liver disease who are actively bleeding or who require prophylaxis for surgical bleeding

Official Title
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Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy

Conditions
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Coagulopathy

Intervention / Treatment
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* Biological: Resusix
* Biological: FP24 (Frozen Plasma)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SBP 90-150 mm Hg acquired coagulopathy due to hepatic disease INR >1.4 Order for 1-4 units of plasma for active bleeding or prophylaxis for bleeding prior to surgery or invasive procedure Written informed consent MELD score: 25 or less (1st cohort), 35 or less (2nd cohort) Exclusion Criteria: Pregnant women Incarcerated patients Life expectancy less than 72 hours Severe bleeding at time of enrollment HIV, sepsis, intracranial bleeding, congenital disorder, anti-phospholipid antibody syndrome or known lupus anticoagulant antibodies Receipt of plasma products, coagulation factor concentrates or anti-platelets within 3 days of enrollment Specific factor inhibitor activity or history of hypersensitivity to plasma-derived products Receipt of iv heparin within 24 hours of enrollment Use of a continuous infusion of an intravenous vasoactive medication Thrombocytopenia BMI greater than or equal to 40 kg/m2 Participation in another clinical trial within 30 days of enrollment and received investigational product that may impact safety or efficacy of this study West Haven Hepatic Encephalopathy Grade 3 or 4 (cohort 1) and Grade 4 (cohort 2)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized in a 1:1 ratio to receive Resusix or FP24
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resusix<br>The experimental drug (Resusix) will be administered intravenously to subjects enrolled in this arm of the study. Subjects may receive doses of 1-4 units during the blinded intervention period. | Biological: Resusix<br>* spray-dried solvent/detergent treated plasma (blood product)<br>|
| Active Comparator: FP24 (Frozen Plasma)<br>The active comparator FP24 will be administered intravenously to subjects enrolled in this arm of the study. Subjects may receive doses of 1-4 units during the blinded intervention period. | Biological: FP24 (Frozen Plasma)<br>* plasma frozen within 24 hours of phlebotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in INR | Measured as a ratio | 120 minutes | 
| Total incidence of all related SAEs | Count of events | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activated partial thromboplastin time (aPTT) | Measured in seconds | 72 hours | 
| Change in platelet count | Measured in x10.e3/uL | 72 hours | 
| Change in hemoglobin | Measured in g/L | 72 hours | 
| Change in clotting function | Measured by thromboelastography (TEG) or rotational thromboelastometry (ROTEM) | 72 hours | 
| Volume of plasma to correct INR | Measured in mL | 72 hours | 
| Time to INR reduction below 1.5 | Measured in minutes | 72 hours | 
| Volume of fluid (e.g., crystalloid, colloid, blood component) administered | Measured in mL | 72 hours | 
| Change in bleeding score in patients with active bleeding | Measured as excellent, good or poor | 120 minutes | 
| Thrombin generation | Measured in nM | 72 hours | 
| Serology for human immunodeficiency virus | Measured in IU/mL | 95 days | 
| Serology for hepatitis | Measured in IU/mL | 95 days | 
| Change in Sequential Organ Failure Assessment Score (SOFA) | Measured as 0 to 4 | 96 hours |