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

Phase 4

Recruiting

• Conditions: Bleeding; Respiratory Insufficiency; Circulatory Failure; Thromboembolism
• Interventions: Drug: Enoxaparin Injectable Solution; Drug: Unfractionated heparin; Drug: Argatroban, 1 Mg/mL Intravenous Solution

• Registration Number: NCT06442267
• Lead Sponsor: Medical University of Vienna

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-06-02
• Study First Posted: 2024-06-04
• Study Start: 2024-07-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-26
• Last Update Posted: 2024-10-29
• Primary Completion: 2027-01-30
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxaparin group	Enoxaparin Injectable Solution	Anticoagulation for the duration of the study will be conducted using subcutaneous Enoxaparin
Unfractionated heparin group	Unfractionated heparin	Anticoagulation for the duration of the study will be conducted using intravenous unfractionated heparin
Argatroban group	Argatroban, 1 Mg/mL Intravenous Solution	Anticoagulation for the duration of the study will be conducted using intravenous Argatroban.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Bleeding events	through duration of the ECMO run; an average of 14 days	Incidence of bleeding events classified according to BARC Criteria

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria