Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This prospective, randomized, controlled pilot trial aims to assess the safety and feasibility of Argatroban as an alternative anticoagulant to unfractionated heparin in patients receiving extracorporeal membrane oxygenation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Argatroban | Experimental | Continuous infusion of 0,3μg/kg/min to target an aPTT of 50-70sec and/or Hemoclot of 0,60 - 0,80 µg/mL |
|
| Unfractionated Heparin | Active Comparator | Continuous infusion of Unfractionated Heparin to target an aPTT of 50-60 seconds and/or Anti-Xa level between 0.20 and 0.30 IU/ml and/or thrombin time >20sec. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Argatroban | Drug | Argatroban is a synthetic, univalent DTI, that directly binds to the catalytic thrombin binding site exerting its effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding and thrombosis with Argatroban compared to unfractionated Heparin (UFH) | Bleeding will be assessed continuously by the investigators according to the BARC bleeding classification, where bleeding type 2 or higher will be considered as clinically significant bleeding; outcome measures will be the incidence of clinically significant bleeding per ECMO day and time to first bleeding; thrombosis is defined as any occurence of thromboembolism including membrane lung exchange due to suspected thrombosis, pulmonary embolism or deep vein thrombosis; outcome measures will be the incidence of thromboembolism per ECMO day and the time to first thromboembolism | From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| study enrollment, study completion and ability to achieve target values of Argatroban as anticoagulant in ECMO | ratio of screened to included patients, proportion of patients who completed the study according to the protocol, proportion of coagulation tests within range and total number of dose adjustments | From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion rate of packed red blood cells assessed as total units/ECMO day | Assessment of the total amount of units (250-300ml each) packed red blood cells transfused per ECMO day following a transfusion threshold of Hb<8g/dl | From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Staudinger, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | State of Vienna | 1090 | Austria |
upon reasonable request
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C031942 | argatroban |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Randomization ratio of 1:1 for anticoagulation with Argatroban or Unfractionated Heparin
Not provided
Not provided
Not provided
Not provided
| Unfractionated heparin | Drug | Unfractionated heparin produces its major anticoagulant effect by inactivating thrombin and activated factor X (factor Xa) through an antithrombin (AT)-dependent mechanism. |
|
| Grading of bleeding | According to the Bleeding Academic Research Consortium type 1 - 5 (Type 1: Bleeding that is not actionable; Type 2: Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional; Type 3a. Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding; Type 3b. Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents; type 3c. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision; Type 4: CABG-related bleeding within 48 hours; Type 5a. Probable fatal bleeding; Type 5b. Definite fatal bleeding (overt or autopsy or imaging confirmation) | From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days |
| Mortality rate at day 28/90 | assessed by chart review or telephone call | Until 90 days after start of study drug administration |
| D006425 |
| Hemic and Lymphatic Diseases |