Safety and Feasibility of Argatroban as Anticoagulant in Adults With ECMO

Phase 2

Recruiting

• Conditions: Anticoagulants and Bleeding Disorders; Extracorporeal Membrane Oxygenation Complication
• Interventions: Drug: Argatroban; Drug: Unfractionated heparin

• Registration Number: NCT05226442
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2021-12-04
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-02-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-14
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Argatroban	Argatroban	Continuous infusion of 0,3μg/kg/min to target an aPTT of 50-70sec and/or Hemoclot of 0,60 - 0,80 µg/mL
Unfractionated Heparin	Unfractionated heparin	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.

Primary Outcome Measures

Name	Time	Method
Bleeding and thrombosis with Argatroban compared to unfractionated Heparin (UFH)	From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days	Bleeding will be assessed continuously by the investigators according to the BARC bleeding classification, where bleeding type 2 or higher will be considered as clinically significant bleeding; outcome measures will be the incidence of clinically significant bleeding per ECMO day and time to first bleeding; thrombosis is defined as any occurence of thromboembolism including membrane lung exchange due to suspected thrombosis, pulmonary embolism or deep vein thrombosis; outcome measures will be the incidence of thromboembolism per ECMO day and the time to first thromboembolism

Secondary Outcome Measures

Name	Time	Method
study enrollment, study completion and ability to achieve target values of Argatroban as anticoagulant in ECMO	From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days	ratio of screened to included patients, proportion of patients who completed the study according to the protocol, proportion of coagulation tests within range and total number of dose adjustments

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria