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Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Cardiac Surgery

NCT06144125 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-06-17

No results posted yet for this study

Summary

The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for cardiac surgery.

Conditions

  • Cardiac Valve Disease

Interventions

BIOLOGICAL

fresh frozen plasma

transfusion of fresh frozen plasma

BIOLOGICAL

prothrombin complex concentrate

prothrombin complex concentrate administration

Sponsors & Collaborators

  • Asan Medical Center

    collaborator OTHER

  • Soonchunhyang University Hospital

    collaborator OTHER

  • Konkuk University Medical Center

    lead OTHER

Principal Investigators

  • Tae-Yop Kim, MD PhD · Konkuk University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-27
Primary Completion
2026-09-30
Completion
2026-10-30

Countries

  • South Korea

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 NCT06144125 on ClinicalTrials.gov