Status:
COMPLETED
Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO
Lead Sponsor:
Medical University of Vienna
Conditions:
Extracorporeal Membrane Oxygenation Complication
Anticoagulants and Bleeding Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 extracorpor...
Eligibility Criteria
Inclusion
- Minimum Age 18 years
- VV- or VA-ECMO therapy
- Minimum of 24h planned ECMO-therapy
Exclusion
- History of Heparin-induced thrombocytopenia (HIT)
- High risk of bleeding, contraindication for anticoagulation (eg. active GI-bleeding, Intracerebral bleeding; Platelet count \<50G/l, congenital bleeding disorder)
- Pregnancy
- Severe Liver disease (SOFA score liver domain 4 points = Bilirubin \>12mg/dl)
- Postoperative admission
- Strong lupus anticoagulant or acquired intrinsic clotting factor deficiency at admission (APTT \>50 sec without anticoagulation).
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05226442
Start Date
December 1 2021
End Date
July 7 2024
Last Update
September 19 2024
Active Locations (1)
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1
Medical University of Vienna
Vienna, Vienna, Austria, 1090