Bleeding, Circulatory Failure, Respiratory Insufficiency, Thromboembolism
Conditions
Keywords
ECMO, Anticoagulation, Thromboembolic Event, Bleeding, extracorporeal life support, anticoagulant, heparin
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
Interventions
Subcutaneous Enoxaparin will be dosed at 0.5 mg/kg twice daily
DRUGArgatroban, 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.
DRUGUnfractionated 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.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Bleeding events | through duration of the ECMO run; an average of 14 days | Incidence of bleeding events classified according to BARC Criteria |
Countries
Austria
Contacts
Primary ContactVincenz Scharner, MD
Outcome results
None listed