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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrafiltration | Experimental | Ultrafiltration is applied at the end of cardiopulmonary bypass. Maximal clot formation (MCF) of ROTEM-EXTEM tracing is reduced before applying the ultrafiltration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrafiltration | Procedure | At the end of CPB procedure, free water is partly removed by ultrafiltration to increase relative mass of red blood cell and plasma components. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Seoul | Seoul | 05030 | South Korea |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D014462 | Ultrafiltration |
| ID | Term |
|---|---|
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D005374 | Filtration |
| D002623 | Chemistry Techniques, Analytical |
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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.
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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 |
| D008919 | Investigative Techniques |
| D055585 | Physical Phenomena |
| D055598 | Chemical Phenomena |