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

NCT03700723 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-01-07

No results posted yet for this study

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

Conditions

  • Coagulopathy

Interventions

BIOLOGICAL

Resusix

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

BIOLOGICAL

FP24 (Frozen Plasma)

plasma frozen within 24 hours of phlebotomy

Sponsors & Collaborators

  • Entegrion, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Galiger · Entegrion, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-14
Primary Completion
2020-04-15
Completion
2020-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03700723 on ClinicalTrials.gov