跳至主要内容
临床试验/NCT04456894
NCT04456894已完成不适用

Importance of Monitoring Primary Hemostasis Pathology in Patients on Extracorporeal Membrane Oxygenation (ECMO) During Lung Transplantation

University Hospital, Motol1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
To find out whether ECMO implantation leads to an early failure of primary hemostasis, which can be diagnosed by POC examination - PFA 200, Rotem / platelet-aggregometry and von Willebrand factor levels

研究概览

简要总结

Lung transplantation is a very long and difficult procedure accompanied by a number of possible complications. In the vast majority of cases, the operation itself is performed using the ECMO support, which can negatively affect blood clotting, especially the formation of a platelet blood clot, i.e. primary hemostasis. Thus, the procedure may be accompanied by considerable blood loss, which amount can subsequently negatively affect the postoperative period. It can be assumed, that precise diagnosis of primary hemostasis disorders and subsequent targeted therapy can reduce blood loss and improve outcome of the patient. However, the role of primary hemostasis has not yet been sufficiently specified in this area. Usually, coagulation functions during surgery, are at our department monitored by using ROTEM tests (assesses clot strength), PFA 200 (assesses primary haemostasis under high shear stress conditions and is very sensitive to vWF deficiency) and ROTEM / platelet (assesses primary haemostasis under "low shear stress" conditions and is very susceptible to platelet dysfunction). Targeted therapy by administering necessary clotting factors is used, if any pathology in these tests is detected. However, it is not known, whether the targeted therapy administered is effective enough in patients during the support of extracorporeal circulation. In our monocentric, prospective, observational study, data from the tests mentioned above will be analyzed, and their correlation with a laboratory examination of VWF levels and activity will be monitored. Based on these data, we will try to determine whether perioperative examination of primary hemostasis during lung transplantation (PFA examination, Rotem / platelet-aggregometry and von Willebrand factor-vWF level) is of clinical significance and whether the diagnosis of hemostasis disorder at this level and subsequent targeted therapy may reduce perioperative blood loss.

详细描述

ECMO is a type of extracorporeal circulation that has experienced a significant increase in use in the last decade as a substitute for lung or heart functions in patients, both perioperatively - especially extensive thoracic surgery procedures such as lung transplantation, or in resuscitation care - in life-threatening conditions associated with heart or lung failure. It uses the classical principle of extracorporeal circulation technology to create continuous, non-pulsating blood flow and, at the same time, its extracorporeal oxygenation. In its two basic configurations, it can only be used to provide respiratory support (veno-venous configuration, VV ECMO), or also cardiac support (veno-arterial configuration, VA ECMO).

Due to the fact that ECMO circuit is an artificial system consisting of cannulas, blood pump and oxygenator itself, the blood is exposed to a huge surface that is not covered by endothelium, thus stimulates the activation of proinflammatory and procoagulant systems. This exposure results in a prothrombotic condition that is associated with a high risk of thrombotic complications. At the same time, however, with this continuous activation of the coagulation cascade, platelets and coagulation factors are depleted, this may lead to an increased risk of bleeding. Pathological shear stress may result in direct binding of VWF (von Willebrand factor) and the platelet GPIIb / IIIa receptor, resulting in their activation and thrombotic complications, however, the effect of non-physiological shear stress may also lead to loss of GPIbα and GPVI platelet receptors, which, in the opposite, causes a disorder of their adhesion and aggregation to VWF and collagen and increases risk of bleeding. Another important factor is loss and fragmentation of the large VWF multimers, a condition known as acquired von Willebrand's syndrome, which causes platelet adhesion to be impaired and thus contributes to bleeding complications.

Both of these situations, definitely, increase morbidity and mortality in patients, so it is necessary to find an optimal and reliable options for the coagulation system functions monitoration, based on which it is possible to immediately perform a targeted therapeutic intervention.

Results of several studies suggest, that increased platelet activation or decreased function results in both thrombotic and bleeding complications in patients requiring extracorporeal support, and these changes cannot be detected by tests, which are usually performed (ROTEM or other common coagulation tests).

Hypothesis:

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients undergoing elective bilateral lung transplantation on ECMO

排除标准

  • patients on dual antiplatelets therapy or patients with vWF disease

结局指标

主要结局

To find out whether ECMO implantation leads to an early failure of primary hemostasis, which can be diagnosed by POC examination - PFA 200, Rotem / platelet-aggregometry and von Willebrand factor levels

时间窗: 1 year

To compare primary hemostasis before and after ECMO implantation

To find out whether targeted therapy of primary hemostasis disorders (based on the results of POC tests) leads to normalization of these tests results and cessation of bleeding

时间窗: 1 year

To evaluate whether aimed therapy based on results of POC tests leads to improvement of test results and bleeding

To find out whether aimed treatment during ECMO will be effective or whether primary hemostasis pathology can be by-passed by activated FVIIa

时间窗: 1 year

In case that aimed therapy does not stop bleeding or improved POC tests, activated FVIIa in small dose of 15-30 ug/kg can be used to ,,by-pass" primary hemostasis

次要结局

  • To identify the most reliable method for the assessment of primary hemostasis(1 year)
  • To determine the extent of correlation of POC tests of primary hemostasis and laboratory examination of VWF function and quantity(1 year)

研究者

发起方
University Hospital, Motol
申办方类型
Other
责任方
Principal Investigator
主要研究者

Durila Miroslav MUDr. Ph.D.

assoc.prof. MD. Miroslav Durila, PhD.

University Hospital, Motol

研究点 (1)

Loading locations...

相似试验