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OpenTrials
Completed

NCT Number: NCT04031144

Ultrafiltration on Coagulation Function in Cardiac Surgery

To determine the effect of modified ultrafiltration, which is usually employed for reducing free water at the end of cardiopulmonary bypass (CPB), on coagulation profile in patients undergoing cardiac surgery

Completed

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Key information

Conditions

Cardiac Valve Disease Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Heart Valve Diseases Thrombosis Vascular Diseases

Age range

19 month–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konkuk University Medical Center

Seoul, 05030, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB)
  • maximal clot formation (MCF) in ROTEM-EXTEM is reduced (< 50.5 mm before applying ultrafiltration)

Exclusion criteria

  • transfusion of packed RBC> 3 units during CPB
  • total ultrafiltration volume < 250 ml
  • hyperfibrinolysis (lysis% > 10%) before applying ultrafiltration

Treatment and study plan

Ultrafiltration

Procedure

At the end of CPB procedure, free water is partly removed by ultrafiltration to increase relative mass of red blood cell and plasma components.

Primary outcomes

  1. Change of Maximal clot formation (MCF) in rotational thromboelastometry, EXTEM assay

    Time frame: 5 min-before and 5 min-after applying ultrafiltration

    change of MCF in EXTEM assay before and after applying ultrafiltration

Secondary outcomes

  1. Change of Clotting time (CT) in rotational thromboelastometry, EXTEM assay

    Time frame: 5 min-before and 5 min-after applying ultrafiltration

    change of CT in EXTEM assay before and after applying ultrafiltration

  2. Change of Maximal clot formation at 5 min (A5) in rotational thromboelastometry, FIBTEM assay

    Time frame: 5 min-before and 5 min-after applying ultrafiltration

    change of A5 in FIBTEM assay before and after applying ultrafiltration

  3. Change of Percent of lysis (lysis%) in rotational thromboelastometry, EXTEM assay

    Time frame: 5 min-before and 5 min-after applying ultrafiltration

    change of lysis% before and after applying ultrafiltration

  4. Hematocrit (Hct) change

    Time frame: 5 min-before and 5 min-after applying ultrafiltration

    change of Hct before and after applying ultrafiltration

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Effect of Ultrafiltration Before Weaning From Cardiopulmonary Bypass on Post-bypass Coagulation Function in Cardiac Surgery

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2019
Registry last updated
Sep 12, 2025

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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