Investigation of Systemic and Regional Haemostasis During Liver Transplantation by Comparing ClotPro® and TEG ® Viscoelastic Tests
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Correlation between TEG® and ClotPro® parameters
研究概览
简要总结
The purpose of the research is to compare the global and the portal haemostasis during liver transplantation by functional investigations using TEG® and ClotPro® tests. The study aims at revealing important coagulation-associated links affecting the outcome of the liver transplant surgery.
详细描述
Donor data Liver donor data are investigated following the "Donor Query" used for donor reports of the Organ Coordination Office of the Hungarian National Blood Transfusion Service. (http://www.ovsz.hu/sites/ovsz.hu/files/szervadomanyozas_dokumentum/donacio/donorlekerdezo-2013-06-03.pdf) The donor is identified by the alarm ID and the Eurotransplant number (ETnr). Independently of this study, the "Donor Query" is completed for all donor reports and helps to asses donor suitability.
Recipient preoperative data In case of a liver alarm, age, body metrics, medical history, type and severity of hepatic disease, concomitant diseases, and admission laboratory test results of the recipient are recorded. Independently of this study, these data/procedures are recorded/performed for all liver transplant candidates.
Surgical data In addition to technical data of the surgery, data on intraoperative fluid balance, transfusion need, supportive therapy (vasopressor or inotropic therapy, renal replacement therapy), and number and indication of any reoperation are also recorded.
Intraoperative sampling times and investigations
During a liver transplantation, independently of this study, the following procedures are performed to monitor the patient's haemodynamics, homeostasis, and haemostasis:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Correlation between TEG® and ClotPro® parameters
时间窗: 24 hours
If there is correlation between TEG® and ClotPro® parameters: 1. reaction time (R) in citrated kaolin TEG (CK-TEG) and clotting time (CT) in IN-test (ClotPro®) 2. kinetics (K) in CK-TEG and clot formation time (CFT) in IN-test 3. Alpha-angel in CK-TEG and IN-test 4. maximum amplitudo (MA) in CK-TEG and maximum clot firmness (MCF) in IN-test 5. percent rate of lysis (Ly30) in CK-TEG and clot lyzis index (CLI30) in IN-test
次要结局
- Correlation between local and systemic haemostasis and any subsequent coagulopathic or thrombotic complications(24 hours)
- Difference between systemic and the portal haemostasis(24 hours)
- Correlation between the fetures of the intraoperative systemic and regional haemostasis and severity of the liver disease(24 hours)
研究者
Janos Fazakas MD, PhD
Associate Professor
Semmelweis University