Ultrafiltration on Coagulation Function in Cardiac Surgery
NCT ID: NCT04031144
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2020-01-30
2023-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
ROC analysis of the preliminary data was performed, and the cut-off value was 50.5 mm.
The sample size of the present study is determined by using these data. The minimum sample size to detect the observed difference after applying ultrafiltration was 26. Considering 50% possible loss, 39 patients will be recruited for the primary analysis.
Patients scheduled for elective cardiac surgery with cardiopulmonary bypass are recruited first, and the data from patients with MCF \<50.5 mm will be included in the final analysis.
TREATMENT
NONE
Study Groups
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Ultrafiltration
Ultrafiltration is applied at the end of cardiopulmonary bypass. Maximal clot formation (MCF) of ROTEM-EXTEM tracing is reduced before applying the ultrafiltration.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* maximal clot formation (MCF) in ROTEM-EXTEM is reduced (\< 50.5 mm before applying ultrafiltration)
Exclusion Criteria
* total ultrafiltration volume \< 250 ml
* hyperfibrinolysis (lysis% \> 10%) before applying ultrafiltration
19 Months
75 Years
ALL
Yes
Sponsors
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Konkuk University Medical Center
OTHER
Responsible Party
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Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Locations
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Konkuk University Medical Center
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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KUMC 2019-05-008
Identifier Type: -
Identifier Source: org_study_id
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