Comparison of Time Taken for Diagnosing Intraoperative Coagulopathies: Point-of-care Viscoelastic Tests vs Standard Central Laboratory Tests
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 4
- 主要终点
- Time for establishing a diagnosis using viscoelastic test and SCL test, minute
研究概览
简要总结
The present study is a prospective, multi-center observational trial comparing the times taken to diagnose coagulopathies using point-of-care (POC) viscoelastic tests or standard central laboratory tests (SCL tests) in patients with intraoperative bleeding.
详细描述
The present study is a prospective multi-center observational trial comparing the time for diagnosing coagulopathies using POC viscoelastic tests, such as rotational thromboelastometry (ROTEM) and thromboelastography (TEG) and standard central laboratory tests (SCL test, such as PT-INR, aPTT, s-fibrinogen level, platelet count) in intraoperative bleeding patients.
The study will be performed during surgeries that are expected to entail a moderate to severe amount of bleeding and warrant the use of either POC viscoelastic tests, SCL tests, or both to determine the possible association of coagulopathy.
The tests will be conducted when an intraoperative condition requires identifying possible associations of coagulopathies during and after surgical bleeding. The test results will prompt appropriate coagulation management.
The primary objective is to compare the diagnosis time for intraoperative coagulopathy using the POC viscoelastic test or SCL test. The time will be defined as the time elapsed from the time obtaining a blood sample for the POC viscoelastic test or SCL test to the time acknowledging the test results.
Researchers hypothesized that using POC viscoelastic tests would shorten the time for diagnosis compared to SCL tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 who will undergo elective surgery with a high risk of moderate to severe amount of intraoperative bleeding or coagulopathy (e.g., cardiac surgery, joint replacement, spine surgery, hepatectomy, radical prostatectomy)
- •patients who provide written informed consent
- •patients who may warrant the intraoperative use of POC viscoelastic test or SCL test
排除标准
- •pregnancy
- •withdrawal of consent
- •termination of surgery without performing either POC viscoelastic test or SCL tests
- •when the study conductor deems it inappropriate to proceed with the protocol with the patient
结局指标
主要结局
Time for establishing a diagnosis using viscoelastic test and SCL test, minute
时间窗: From the start and to the end of surgery, an average of 6 hours
Lapsed time (minute) from obtaining a blood sample to identifying association or absence of coagulation dysfunction
次要结局
- Test results from viscoelastic test and SCL test(From the start and to the end of surgery, an average of 6 hours)
- The difference in the percentages of patients that lead to the diagnosis of coagulopathies for viscoelastic test and SCL tests(From the start and to the end of surgery, an average of 6 hours)
- Time for initiating a treatment, munute(From the start and to the end of surgery, an average of 6 hours)
- Time taken to complete the delivery of the blood products to the operation room, minute(From the start and to the end of surgery, an average of 6 hours)
- Amount of blood products transfused if indicated specific to each test, unit(From the start and to the end of surgery, an average of 6 hours)
- comparisons of diagnosis time between POC-viscoelastic test and SCL test(From the start and to the end of surgery, an average of 6 hours)
研究者
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center