A prospective randomized pilot trial on safety and feasibility of Argatroban as blood thinner in patients with heart-lung machine

Phase 1

• Conditions: patients requiring treatment with extracorporeal membrane oxygenation; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2021-001456-34-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-25
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

•Minimum Age 18 years
•VV- or VA-ECMO therapy
•Minimum of 24h planned ECMO-therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified