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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06442267
Other study ID # 1644/2022
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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