Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO

Medical University of Vienna

Status and phase: Completed; Phase 3; Phase 2

Conditions: Extracorporeal Membrane Oxygenation Complication; Anticoagulants and Bleeding Disorders

Treatments: Drug: Unfractionated heparin; Drug: Argatroban

Study type: Interventional

Funder types: Other

Identifiers

NCT05226442

Argatroban_ECMO

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Argatroban

Experimental group

Description:

Continuous infusion of 0,3μg/kg/min to target an aPTT of 50-70sec and/or Hemoclot of 0,60 - 0,80 µg/mL

Treatment:

Drug: Argatroban

Unfractionated Heparin

Active Comparator group

Description:

Continuous infusion of Unfractionated Heparin to target an aPTT of 50-60 seconds and/or Anti-Xa level between 0.20 and 0.30 IU/ml and/or thrombin time \>20sec.

Treatment:

Drug: Unfractionated heparin