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

Phase 4RecruitingNCT06442267

Medical University of Vienna90 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Respiratory Insufficiency Circulatory Failure Thromboembolism Bleeding

Enoxaparin Injectable SolutionDRUG

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

Argatroban, 1 Mg/mL Intravenous SolutionDRUG

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 heparinDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * either * require ECMO support or * have been started on ECMO therapy within the last 12 hours Exclusion Criteria: * Patients exhibiting contraindications to anticoagulation in general or any of the three investigated substances * Patients who are pregnant * Patients suffering from a clinically relevant pre-existing coagulopathy * Patients, for whom screening, randomization and implementation of study protocol cannot be initiated within 12 hours after cannulation * Patients receiving ongoing therapeutic systemic anticoagulation prior to ECMO implantation, or exhibiting an indication for therapeutic anticoagulation (e.g., pulmonary embolism) * Patients whose total duration of ECMO support lasts less than 24 hours * Patients with start of ECMO support during CPR (eCPR) * Patients with passive decarboxylation, without an active pumping system * Patients, who have been weaned off ECMO support within the last 30 days * Patients with central ECMO cannulation and/or after cardiopulmonary bypass

Outcomes

Primary Outcomes

Incidence of thromboembolic events during ECMO therapy

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

Time frame: through duration of the ECMO run; an average of 14 days

Secondary Outcomes

Bleeding events

Incidence of bleeding events classified according to BARC Criteria