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临床试验/NCT05252559
NCT05252559已完成不适用

Effect of Modified Ultrafiltration on Whole Blood Coagulation in Cardiac Surgery With Cardiopulmonary Bypass: Retrospective Analysis

Konkuk University Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年8月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Konkuk University Medical Center

研究点 (1)

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