CompletedPhase 2/3

Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO

Austria40 participantsStarted 2021-12-01

Plain-language 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 extracorporeal membrane oxygenation.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Minimum Age 18 years * VV- or VA-ECMO therapy * Minimum of 24h planned ECMO-therapy Exclusion Criteria: * 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).

What they're measuring

Bleeding and thrombosis with Argatroban compared to unfractionated Heparin (UFH)

Timeframe: From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days

Trial details

NCT IDNCT05226442

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-07

View on ClinicalTrials.gov More Extracorporeal Membrane Oxygenation Complication trials