Effect of Modified Ultrafiltration on Whole Blood Coagulation in Cardiac Surgery With Cardiopulmonary Bypass: Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- maximal clot firmness (MCF) of EXTEM assay
研究概览
简要总结
In cardiac surgery patients with CPB-induced dilutional coagulopathy, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components before the weaning from CPB. The impact of UF on the clot strength is determined by analyzing the changes of maximal clot formation in EXTEM assay (MCF-EXTEM) in the ROTEM test in patients who underwent elective cardiac valve surgery in KUMC.
详细描述
In cardiac surgery patients, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components during cardiopulmonary bypass (CPB). Concentrating plasma substrate of UF would be beneficial in attenuating CPB-induced dilutional coagulopathy. This study was to investigate whether MUF affected viscoelastic profiles during CPB for cardiac surgery.
Patients who underwent elective cardiac surgery and MUF at the end of CPB during January 2019-December 2021 are recruited. Using the patients' electronic medical records, the values of maximum clot firmness of EXTEM assay (MCF-EXTEM) of rotational thromboelastometry (ROTEM) test before and after applying MUF are retrospectively analyzed.
As the primary measure, we determine the changes of MCF-EXTEM after applying MUF. With an assumption that MUF increased MCF-EXTEM, the receiver operating characteristic (ROC) analysis is applied to MCF-EXTEM change. The area under the ROC curve is determined and the cut-off value is estimated with specificity and sensitivity in Youden's J statistics. The change of MCF-EXTEM in patients who show MCF-EXTEM less than the cut-off value is analyzed. The changes of hematocrit (Hct) before and after applying MUF is also determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients underwent cardiac surgery during Jan 2019-Dec 2021
- •Patients underwent moderate hypothermic CPB
- •Patients underwent ultrafiltration during CPB
- •Patients underwent ROTEM tests (EXTEM assays and FIBTEM assay) before and after applying ultrafiltration
排除标准
- •Patients underwent packed RBC transfusion > 3 units during CPB
- •patients underwent ultrafiltration but the removed free water was < 250 ml
- •Patients underwent deep hypothermia
结局指标
主要结局
maximal clot firmness (MCF) of EXTEM assay
时间窗: 30 minute after the completion of ultrafiltration
change of MCF-EXTEM assay
次要结局
- maximal clot firmness (MCF) of EXTEM assay to be improved by ultrafiltration(30 minute after the completion of ultrafiltration)
- maximal clot firmness (MCF) of EXTEM assay not to be improved by ultrafiltration(30 minute after the completion of ultrafiltration)
- cut-off value of MCF-EXTEM to be improved by ultrafiltration(30 minute after the completion of ultrafiltration)
研究者
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center
