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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-14

Study Completion Date

2020-04-15

Brief Summary

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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

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Detailed Description

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Conditions

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Coagulopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized in a 1:1 ratio to receive Resusix or FP24

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Single blind

Study Groups

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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.

Group Type EXPERIMENTAL

Resusix

Intervention Type BIOLOGICAL

spray-dried solvent/detergent treated plasma (blood product)

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.

Group Type ACTIVE_COMPARATOR

FP24 (Frozen Plasma)

Intervention Type BIOLOGICAL

plasma frozen within 24 hours of phlebotomy

Interventions

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Resusix

spray-dried solvent/detergent treated plasma (blood product)

Intervention Type BIOLOGICAL

FP24 (Frozen Plasma)

plasma frozen within 24 hours of phlebotomy

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No