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

Entegrion

Status and phase: Terminated; Phase 2

Conditions: Coagulopathy

Treatments: Biological: FP24 (Frozen Plasma); Biological: Resusix

Study type: Interventional

Funder types: Industry

Identifiers

NCT03700723

RSX-201

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 2 patient groups

Resusix

Experimental group

Description:

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.

Treatment:

Biological: Resusix

FP24 (Frozen Plasma)

Active Comparator group

Description:

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.

Treatment:

Biological: FP24 (Frozen Plasma)