Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO

Last updated: September 9, 2024
Sponsor: Medical University of Vienna
Overall Status: Completed

Phase

2/3

Condition

Blood Clots

Treatment

Argatroban

Unfractionated heparin

Clinical Study ID

NCT05226442
Argatroban_ECMO
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Minimum Age 18 years

  • VV- or VA-ECMO therapy

  • Minimum of 24h planned ECMO-therapy

Exclusion

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 atadmission (APTT >50 sec without anticoagulation).

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Argatroban
Phase: 2/3
Study Start date:
December 01, 2021
Estimated Completion Date:
July 07, 2024

Connect with a study center

  • Medical University of Vienna

    Vienna, 1090
    Austria

    Site Not Available

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