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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enoxaparin group | Experimental | Anticoagulation for the duration of the study will be conducted using subcutaneous Enoxaparin |
|
| Argatroban group | Experimental | Anticoagulation for the duration of the study will be conducted using intravenous Argatroban. |
|
| Unfractionated heparin group | Active Comparator | Anticoagulation for the duration of the study will be conducted using intravenous unfractionated heparin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin Injectable Solution | Drug | Subcutaneous Enoxaparin will be dosed at 0.5 mg/kg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of thromboembolic events during ECMO therapy | Clinically relevant thromboembolic events (Clinical suspicion; confirmation via imaging)
| through duration of the ECMO run; an average of 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
either
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincenz Scharner, MD | Contact | +43 1 40400 | 4100 | vincenz.scharner@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Johannes Gratz, PD, MD, PhD | Medical Univeristy of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | State of Vienna | 1090 | Austria |
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| Argatroban, 1 Mg/mL Intravenous Solution | Drug | 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 | Drug | 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. |
|
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012769 | Shock |
| D013923 | Thromboembolism |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C031942 | argatroban |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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