Clinical trial NCT03700723: Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
Official title: Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Coagulopathy
Lead sponsor: Entegrion, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized in a 1:1 ratio to receive Resusix or FP24
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Change in INR
timeFrame: 120 minutes
measure: Total incidence of all related SAEs
timeFrame: 7 days
Secondary outcomes:
measure: Change in activated partial thromboplastin time (aPTT)
timeFrame: 72 hours
measure: Change in platelet count
timeFrame: 72 hours
measure: Change in hemoglobin
timeFrame: 72 hours
measure: Change in clotting function
timeFrame: 72 hours
measure: Volume of plasma to correct INR
timeFrame: 72 hours
measure: Time to INR reduction below 1.5
timeFrame: 72 hours
measure: Volume of fluid (e.g., crystalloid, colloid, blood component) administered
timeFrame: 72 hours
measure: Change in bleeding score in patients with active bleeding
timeFrame: 120 minutes
measure: Thrombin generation
timeFrame: 72 hours
measure: Serology for human immunodeficiency virus
timeFrame: 95 days
measure: Serology for hepatitis
timeFrame: 95 days
measure: Change in Sequential Organ Failure Assessment Score (SOFA)
timeFrame: 96 hours
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Saint Louis
country: United States
facility: Washington University St. Louis
state: Missouri
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Entegrion, Inc.
name: Michael Galiger
role: STUDY_DIRECTOR
References: