Safety and Feasibility of Argatroban as Anticoagulant in Adults With ECMO

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Argatroban; Calcium heparin; Heparin

Criteria

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).