跳至主要内容
临床试验/NCT04879550
NCT04879550已完成不适用

Prospective Investigation of the Association of Antithrombin III Deficiency With Thrombotic Events in Adult Patients With ECMO

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月1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
50
试验地点
1
主要终点
Antithrombin 3 activity level

研究概览

简要总结

There are publications showing a decrease in Antithrombin III levels of continuous flow and routine heparin therapy in adult patients undergoing Extracorporeal Membrane Oxygenation (ECMO) however, there is not enough data. One of the multifactorial causes affecting bleeding / thrombosis complications and ACT levels may be acquired Antithrombin III deficiency.

The Antithrombin III activity test results from the patients to be included in the study during the study will be recorded immediately after ECMO run, at the 24th hour before the heparin infusion start and at the 48th, 72nd and 96th hours following the follow-up. The results will be analyzed to figure out a relationship between decreasing Antithrombin 3 values and thrombotic events.

详细描述

ECMO is applied in patients with acute severe heart or lung failure. The treatment protocol of patients undergoing ECMO is carefully arranged against the risk of bleeding / thrombosis.

According to the general protocol, heparin infusion therapy is started at the 24th hour after ECMO application. The risk of bleeding / thrombosis is avoided by adjusting the heparin infusion dose with Activated Clotting Time (ACT) control. However, over time, thrombocytopenia and fluctuations in ACT level are observed in patients. It may be necessary to increase the dose of heparin given during the prolonged period. One of the multifactorial causes affecting bleeding / thrombosis complications and ACT levels may be acquired Antithrombin III deficiency. There are publications reporting a decrease in Antithrombin III levels of continuous flow and routine heparin therapy in adult patients undergoing ECMO; however, there is not enough data.

The Antithrombin III activity test results from the patients to be included in the study during the study will be recorded immediately after ECMO run, at the 24th hour before the heparin infusion start and at the 48th, 72nd and 96th hours following the follow-up. The results will be analyzed to figure out a relationship between decreasing Antithrombin 3 values and thrombotic events.

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

入选标准

  • Being over the age of 18
  • Patients with ECMO run for 3 days or more (to be able to determine at least 3 antithrombin 3 levels)

排除标准

  • Patients with ECMO run less than 3 days

结局指标

主要结局

Antithrombin 3 activity level

时间窗: 5 days

Antithrombin 3 activity test levels will be checked in the first 5 days after ecmo application.

次要结局

  • Thrombosis and Bleeding Events(1 week)

研究者

发起方
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arif Yasin Çakmak

Principal Investigator

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

研究点 (1)

Loading locations...

相似试验