NCT03700723TerminatedPhase 2
Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Entegrion, Inc.
- Enrollment
- 4
- Locations
- 6
- Primary Endpoint
- Change in INR
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Single blind
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Change in INR
Time Frame: 120 minutes
Measured as a ratio
Total incidence of all related SAEs
Time Frame: 7 days
Count of events
Secondary Outcomes
- Change in hemoglobin(72 hours)
- Change in activated partial thromboplastin time (aPTT)(72 hours)
- Change in platelet count(72 hours)
- Change in clotting function(72 hours)
- Volume of plasma to correct INR(72 hours)
- Time to INR reduction below 1.5(72 hours)
- Volume of fluid (e.g., crystalloid, colloid, blood component) administered(72 hours)
- Change in bleeding score in patients with active bleeding(120 minutes)
- Thrombin generation(72 hours)
- Serology for human immunodeficiency virus(95 days)
- Serology for hepatitis(95 days)
- Change in Sequential Organ Failure Assessment Score (SOFA)(96 hours)
Investigators
Study Sites (6)
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