Clinical trial

A Three-arm Randomized Controlled Non-inferiority Pilot Study Comparing Anticoagulation Strategies Using Unfractionated Heparin, Argatroban and Low-molecular-weight Heparin for Extracorporeal Membrane Oxygenation Support

Name

1644/2022

Description

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

Trial arms

Trial start

2024-05-27

Estimated PCD

2026-07-30

Trial end

2026-11-30

Status

Recruiting

Phase

Early phase I

Treatment

Enoxaparin Injectable Solution

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

Arms:

Enoxaparin group

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.

Arms:

Argatroban group

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.

Arms:

Unfractionated heparin group

Size

Primary endpoint

Incidence of thromboembolic events during ECMO therapy

through duration of the ECMO run; an average of 14 days

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2024-06-04

1 organization

3 products

4 indications

Organization

Medical University of Vienna

Product

Enoxaparin

Indication

Respiratory Insufficiency

Indication