Ultrafiltration on Coagulation Function in Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Cardiac Valve Disease

• Registration Number: NCT04031144
• Lead Sponsor: Konkuk University Medical Center

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-21
• Study First Submitted QC: 2019-07-21
• Study First Posted: 2019-07-24
• Study Start: 2020-01-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-06
• Last Update Posted: 2023-05-09
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change of Maximal clot formation (MCF) in rotational thromboelastometry, EXTEM assay	5 min-before and 5 min-after applying ultrafiltration	change of MCF in EXTEM assay before and after applying ultrafiltration

Secondary Outcome Measures

Name	Time	Method
Change of Clotting time (CT) in rotational thromboelastometry, EXTEM assay	5 min-before and 5 min-after applying ultrafiltration	change of CT in EXTEM assay before and after applying ultrafiltration
Change of Percent of lysis (lysis%) in rotational thromboelastometry, EXTEM assay	5 min-before and 5 min-after applying ultrafiltration	change of lysis% before and after applying ultrafiltration
Hematocrit (Hct) change	5 min-before and 5 min-after applying ultrafiltration	change of Hct before and after applying ultrafiltration
Change of Maximal clot formation at 5 min (A5) in rotational thromboelastometry, FIBTEM assay	5 min-before and 5 min-after applying ultrafiltration	change of A5 in FIBTEM assay before and after applying ultrafiltration

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of