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Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery

NCT05523297 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2025-08-15

Study results available
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Summary

This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.

Conditions

  • Bleeding Cardiac Surgery Patients

Interventions

DRUG

Octaplex

Prothrombin complex concentrate

DRUG

Frozen Plasma Product, Human

If additional treatment is required after the maximum dose of IMP is administered or the treatment period has elapsed, patients in both groups will receive frozen plasma

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2024-06-27
Completion
2024-06-27
FDA Drug
Yes

Countries

  • United States
  • Canada

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 NCT05523297 on ClinicalTrials.gov