Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enoxaparin Injectable Solution, Argatroban, 1 Mg/mL Intravenous Solution, Unfractionated heparin.
- Who it may be relevant to
- Registry conditions: Respiratory Insufficiency, Circulatory Failure, Thromboembolism, Bleeding. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug Enoxaparin Injectable Solution
Subcutaneous Enoxaparin will be dosed at 0.5 mg/kg twice daily - Drug 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. - Drug 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.
Primary outcome measures
- Incidence of thromboembolic events during ECMO therapy [Time frame: through duration of the ECMO run; an average of 14 days]
Secondary outcome measures (1)
- Bleeding events [Time frame: through duration of the ECMO run; an average of 14 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Austria · 1 center
- Medical University of Vienna — Vienna
Identifiers
NCT: NCT06442267 · 1644/2022