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PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding

NCT02557672 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2022-06-07

Study results available
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Summary

This will be the first prospective randomized controlled clinical trial directly comparing Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a difference in bleeding and transfusion requirements in patients received PCC versus FFP?

Conditions

  • Bleeding
  • Blood Loss, Surgical
  • Cardiovascular Surgical Procedures
  • Prothrombin Complex Concentrates
  • Fresh Frozen Plasma

Interventions

DRUG

Prothrombin complex concentrate (Human)

PCC (Kcentra)

BIOLOGICAL

Fresh frozen plasma (FFP)

FFP

Sponsors & Collaborators

  • CSL Behring

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Gregory Nuttall, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2021-06-30
Completion
2022-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02557672 on ClinicalTrials.gov