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

Phase 2

Terminated

• Conditions: Coagulopathy

• Registration Number: NCT03700723
• Lead Sponsor: Entegrion, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-10-07
• Study First Posted: 2018-10-09
• Study Start: 2018-12-14
• Primary Completion: 2020-04-15
• Study Completion: 2020-04-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-06
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in INR	120 minutes	Measured as a ratio
Total incidence of all related SAEs	7 days	Count of events

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

Washington University St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States