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NCT04031144 Clinical Trial

Ultrafiltration on Coagulation Function in Cardiac Surgery

Cardiac Valve Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04031144
Other study ID # KUMC 2019-05-008
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 30, 2020
Est. completion date October 30, 2023

Study information
Verified date May 2023
Source Konkuk University Medical Center
Contact Seong-Ho Lee
Phone 82-2-2030-6542
Email 20190508@kuh.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 28
Est. completion date October 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Months to 75 Years
Eligibility Inclusion Criteria: - patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB) - maximal clot formation (MCF) in ROTEM-EXTEM is reduced Exclusion Criteria: - MCF > 50.5 mm before applying ultrafiltration - transfusion of packed RBC> 3 units during CPB - total ultrafiltration volume < 250 ml - hyperfibrinolysis (lysis% > 10%) before applying ultrafiltration

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Konkuk University Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of Maximal clot formation (MCF) in rotational thromboelastometry, EXTEM assay change of MCF in EXTEM assay before and after applying ultrafiltration 5 min-before and 5 min-after applying ultrafiltration
Secondary Change of Clotting time (CT) in rotational thromboelastometry, EXTEM assay change of CT in EXTEM assay before and after applying ultrafiltration 5 min-before and 5 min-after applying ultrafiltration
Secondary Change of Maximal clot formation at 5 min (A5) in rotational thromboelastometry, FIBTEM assay change of A5 in FIBTEM assay before and after applying ultrafiltration 5 min-before and 5 min-after applying ultrafiltration
Secondary Change of Percent of lysis (lysis%) in rotational thromboelastometry, EXTEM assay change of lysis% before and after applying ultrafiltration 5 min-before and 5 min-after applying ultrafiltration
Secondary Hematocrit (Hct) change change of Hct before and after applying ultrafiltration 5 min-before and 5 min-after applying ultrafiltration
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