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

Bleeding Clinical Trial

— CASUAL-ECMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06442267
• Other study ID #: 1644/2022
• Status: Recruiting
• Phase: Phase 4
• Start date: June 25, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: June 2024
• Source: Medical University of Vienna
• Contact: Vincenz Scharner, MD
• Phone: +43 1 40400
• Email: vincenz.scharner[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Circulatory Failure
• Respiratory Insufficiency
• Shock
• Thromboembolism

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through duration of the ECMO run; an average of 14 days
Secondary	Bleeding events	Incidence of bleeding events classified according to BARC Criteria	through duration of the ECMO run; an average of 14 days