Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
either
require ECMO support or
have been started on ECMO therapy within the last 12 hours
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Enoxaparin Injectable Solution
DrugSubcutaneous Enoxaparin will be dosed at 0.5 mg/kg twice daily
Argatroban, 1 Mg/mL Intravenous Solution
DrugIntravenous 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
DrugUnfractionated 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Enoxaparin groupExperimental treatment 1 intervention
Group B: Argatroban groupExperimental treatment 1 intervention
Group C: Unfractionated heparin groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
through duration of the ECMO run; an average of 14 daysSecondary outcomes
1
Bleeding events
Incidence of bleeding events classified according to BARC Criteria
Time frame
through duration of the ECMO run; an average of 14 daysSponsors and contacts
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Source ClinicalTrials.gov