Cardiac Valve Disease
Conditions
Keywords
coagulation, ultrafiltration, cardiac surgery
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
Interventions
PROCEDUREUltrafiltration
At the end of CPB procedure, free water is partly removed by ultrafiltration to increase relative mass of red blood cell and plasma components.
Sponsors
Konkuk University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with reduced clot strength before applying ultrafiltration (patients with MCF in ROTEM-EXTEM less than the cut-off value, determined by preliminary analyses, n=30). 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.
Eligibility
Sex/Gender
ALL
Age
19 Months to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
South Korea
Outcome results
None listed