Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support

Condition(s) studied

Investigational drug(s) / intervention(s)

Enoxaparin Injectable Solution: Subcutaneous Enoxaparin will be dosed at 0.5 mg/kg twice daily

Argatroban, 1 Mg/mL Intravenous Solution: Intravenous Argatroban will be administered as a continuous infusion of 0.1-1 µg/kg/min with a target modified thrombin time measured using Hemoclot of 0,40 - 0,60 µg/mL.

Unfractionated heparin: Unfractionated heparin will be administered as a continuous infusion of 7.5-20 units/kg/h with a target Anti FXa calibrated for UFH of 0.3-0.5 u/mL.

Study summary

A three-arm randomized controlled non-inferiority pilot study comparing anticoagulation strategies using unfractionated heparin, argatroban and enoxaparin for extracorporeal membrane oxygenation support conducted as an investigator-initiated, prospective, parallel group, open-label, active comparator controlled, single center, phase IV study to evaluate the non-inferiority of enoxaparin or argatroban for anticoagulation during ECMO therapy in comparison to the current standard, unfractionated heparin, as measured by the incidence of thromboembolic events during the duration of ECMO therapy

Eligibility

Primary outcome measure(s)

• Incidence of thromboembolic events during ECMO therapy — through duration of the ECMO run; an average of 14 days
  Clinically relevant thromboembolic events (Clinical suspicion; confirmation via imaging) * Pulmonary embolism, deep vein thrombosis * Intracardiac thrombosis * Arterial thromboembolism including myocardial and cerebral infarction * Deep vein thrombosis (detected during daily routine sonography) * Need to exchange ECMO circuit due to acute or incipient clotting

Trial sites (1)

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