NCT07499037

Safety and Efficacy of Low-dose Anticoagulation With Argatroban and Enoxaparin on ECMO

Low-dose Versus Standard-dose Anticoagulation With Argatroban and Enoxaparin During Extracorporeal Membrane Oxygenation Controlled by Anti-IIa and An-ti-Xa, Respectively

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The standard and most common therapy is anticoagulation with heparin according to activated partial thromboplastin time (aPTT) during extracorporeal membrane oxygenation (ECMO) support. The study will focus on evaluating the efficacy and safety of new anticoagulants on ECMO, namely argatroban and enoxaparin in lower doses controlled according to targeted antiIIa and antiXa markers.

Detailed description

This is a phase II academic clinical trial designed to evaluate the effect of argatroban and enoxaparin used to enable ECMO support in critically ill patients. The population will consist of patients hospitalised at University Hospital Ostrava and University Hospital Motol Prague. After signing the Informed Con-sent to participate in the study, treatment will be based on the patient's clinical condition and the decision of the attending physician. The study participants will be patients diagnosed with heart failure (including cardiac arrest) or pulmonary failure, adult men and women, using argatroban or enoxaparin.

Conditions

• Pneumonia
• Heart Failure

Interventions

Type	Name	Description
DRUG	Low anticoagulation dose of argatroban and enoxaparin during ECMO	Study subjects in this group will receive low anticoagulation dose of argatroban and enoxaparin during ECMO
DRUG	Standard anticoagulation dose of argatroban and enoxaparin during ECMO	Study subjects in this group will receive standard anticoagulation dose of argatroban and enoxaparin during ECMO

Timeline

• Start date: 2027-01-01
• Primary completion: 2029-09-01
• Completion: 2029-12-01
• First posted: 2026-03-27
• Last updated: 2026-04-02

Locations

2 sites across 1 country: Czechia