A Phase 4 interventional study of Enoxaparin Injectable Solution and Argatroban, 1 Mg/mL Intravenous Solution in Respiratory Insufficiency, Circulatory Failure and Thromboembolism, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by Medical University of Vienna · Phase 4, Interventional, and Prevention
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
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Clinically significant
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Anticoagulation for the duration of the study will be conducted using subcutaneous Enoxaparin
Drug: Enoxaparin Injectable Solution
Anticoagulation for the duration of the study will be conducted using intravenous Argatroban.
Drug: Argatroban, 1 Mg/mL Intravenous Solution
Anticoagulation for the duration of the study will be conducted using intravenous unfractionated heparin
Drug: Unfractionated heparin
Subcutaneous Enoxaparin will be dosed at 0.5 mg/kg twice daily
Drug page: Argatroban
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 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.
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 days
Bleeding events
Incidence of bleeding events classified according to BARC Criteria
Time frame: through duration of the ECMO run; an average of 14 days
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Studies of the drugs tested here: Enoxaparin · Argatroban
Medical University of Vienna →