2025-524553-13-00RecruitingPhase 2
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 sites in 1 country200 target enrollmentStarted: March 2, 2026Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
Brief Summary
Description of the efficacy and safety of low dose (LD) and standard dose (SD) anticoagulation with argatroban and enoxaparin in patients on ECMO support.
Study Design
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ECMO support with argatroban / enoxaparin anticoagulation
- •Age ≥ 18 years
- •Obtaining informed consent according to the procedure specified in the protocol
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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
Investigators
Filip Burša, MD, Ph.D., EDEC
Scientific
Fakultni Nemocnice Ostrava
Study Sites (2)
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