2025-524553-13-00招募中2 期
Low-dose versus standard-dose anticoagulation with argatroban or enoxaparin during extracorporeal membrane oxygenation controlled by anti-IIa or anti-Xa assay
Fakultni Nemocnice Ostrava2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年3月2日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- To comprehensively compare the efficacy and safety of anticoagulation therapy in patients on ECMO support with argatroban, enoxaparin and in the combined population of patients with argatroban or enoxaparin
研究概览
简要总结
Description of the efficacy and safety of low dose (LD) and standard dose (SD) anticoagulation with argatroban and enoxaparin in patients on ECMO support.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •ECMO support with argatroban / enoxaparin anticoagulation
- •Age ≥ 18 years
- •Obtaining informed consent according to the procedure specified in the protocol
排除标准
- •Inclusion in the lung transplant program at Motol Hospital
- •Known hypersensitivity to components of the investigational medicinal products
- •Allergic reaction to the active substances of the investigational medicinal products
- •Pregnancy and breastfeeding
结局指标
主要结局
To comprehensively compare the efficacy and safety of anticoagulation therapy in patients on ECMO support with argatroban, enoxaparin and in the combined population of patients with argatroban or enoxaparin
To comprehensively compare the efficacy and safety of anticoagulation therapy in patients on ECMO support with argatroban, enoxaparin and in the combined population of patients with argatroban or enoxaparin
次要结局
- To determine the relationship between argatroban concentration and the incidence of bleeding and thrombotic complications and the consumption of blood derivatives and transfusion products
- To determine the relationship between the dose or concentration of anticoagulant and laboratory parameters for monitoring anticoagulation
- To determine the relationship between laboratory parameters and bleeding and thrombotic complications
研究者
Filip Burša, MD, Ph.D., EDEC
Scientific
Fakultni Nemocnice Ostrava
研究点 (2)
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