Ultrafiltration on Coagulation Function in Cardiac Surgery

Study Overview
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Brief Summary
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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

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

Conditions
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Cardiac Valve Disease

Intervention / Treatment
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* Procedure: Ultrafiltration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Months
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with reduced clot strength before applying ultrafiltration (patients with MCF in ROTEM-EXTEM less than the cut-off value which will be determined by preliminary analyses, n=30). ROC analysis of the preliminary data was performed and the cut-off values 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 by applying ultrafiltration was 25, with a 2-sided significance level of 0.05 and a statistical power of 0.80. Considering 10% of the possible loss, 28 patients will be recruited for the present study. Patients who scheduled for elective cardiac surgery with cardiopulmonary bypass are recruited first, and the data of patients with MCF <50.5 mm will be included to the final analysis.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrafiltration<br>Ultrafiltration is applied at the end of cardiopulmonary bypass. Maximal clot formation (MCF) of ROTEM-EXTEM tracing is reduced before applying the ultrafiltration. | Procedure: Ultrafiltration<br>* At the end of CPB procedure, free water is partly removed by ultrafiltration to increase relative mass of red blood cell and plasma components.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Hematocrit (Hct) change | change of Hct before and after applying ultrafiltration | 5 min-before and 5 min-after applying ultrafiltration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coagulation, ultrafiltration, cardiac surgery