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NCT Number: NCT06144125

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

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.

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Key information

Conditions

Cardiac Valve Disease Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Cardiovascular Diseases Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Embolism and Thrombosis Genetic Diseases, Inborn Genetic Diseases, X-Linked Heart Diseases Heart Valve Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia B Hemorrhage Hemorrhagic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location status: Recruiting

Location contact

Gwnag-Hwa Lee, MD, PhD

CONTACT

[email protected]

+82-2-2030-5114

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing cardiac surgery

Exclusion criteria

  • thrombocytopenia
  • oral anti-coagulant
  • anti platelet agents

Treatment and study plan

fresh frozen plasma

Biological

transfusion of fresh frozen plasma

prothrombin complex concentrate

Biological

prothrombin complex concentrate administration

Primary outcomes

  1. treatment time

    Time frame: 1 min

    duration from the time of diagnosing CT-EXTEM prolongation (ordering PCC or FFP) to the time achieving bleeding control (completing administration of PCC or FFP)

Secondary outcomes

  1. Red Blood Cell amount

    Time frame: I hour

    Red Blood Cell transfusion amount during surgery

  2. FFP amount

    Time frame: 1 hour

    Red Blood Cell transfusion amount during surgery

  3. Platelet amount

    Time frame: 1 hour

    Platelet transfusion amount during surgery

  4. cryoprecipiate amount

    Time frame: 1 hour

    amount of cryoprecipitate transfusion

  5. CT-EXTEM change

    Time frame: 1 min

    clotting time-EXTEM after PCC or FFP

  6. A5-EXTEM change

    Time frame: 1 min

    clot amplitude at 5 min after clot initiation in EXTEM after PCC or FFP

  7. MCF-EXTEM change

    Time frame: 1 min

    Maximal clot firmness in EXTEM after PCC or FFP

  8. A5-FIBTEM change

    Time frame: 1 min

    clot amplitude at 5 min after clot initiation in FIBTEM after PCC or FFP

  9. Postoperative bleeding

    Time frame: 24 hour

    chest tube drainage at postoperative 24 hour

  10. Preparation time

    Time frame: 1 min

    from the start of cross-matching and thawing of FFP or unpacking of PCC in its storage area to the time of its delivery to patients in the operating room

  11. success rate of the 1st coagulation management

    Time frame: 10 min

    incidence of achieving CT-EXTEM < 80 sec after administering PCC or FFP as coagulation management

Other outcomes

  1. Thromboembolism complication

    Time frame: 24 hour

    myocardial infarction, stroke, cerebral infarction, bowel ischemia

Study contacts

Contact information is provided by the study sponsor or research team.

Tae-Yop KIm, MD PhD

CONTACT

[email protected]

+82-10-8811-6942

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Collaborators

  • Asan Medical Center
  • Soonchunhyang University Hospital

Registry information

Official study title

Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Cardiac Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 22, 2023
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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