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

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

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 Overview

• Status: Terminated
• Conditions: Coagulopathy
• Intervention / Treatment: Biological: Resusix; Biological: FP24 (Frozen Plasma)

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University St. Louis
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Resusix; 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; spray-dried solvent/detergent treated plasma (blood product)
ACTIVE_COMPARATOR: FP24 (Frozen Plasma); 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); plasma frozen within 24 hours of phlebotomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Entegrion, Inc.
• Investigators: Study Director: Michael Galiger, Entegrion, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2018
• Primary Completion (ACTUAL): April 15, 2020
• Study Completion (ACTUAL): April 15, 2020

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: October 7, 2018
• First Posted (ACTUAL): October 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: RSX-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No