Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO

NCT ID: NCT05226442

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2024-07-07

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.

Conditions

Extracorporeal Membrane Oxygenation Complication; Anticoagulants and Bleeding Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Argatroban

Intervention Type: DRUG

Argatroban is a synthetic, univalent DTI, that directly binds to the catalytic thrombin binding site exerting its effects

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.

Group Type: ACTIVE_COMPARATOR

Unfractionated heparin

Intervention Type: DRUG

Unfractionated heparin produces its major anticoagulant effect by inactivating thrombin and activated factor X (factor Xa) through an antithrombin (AT)-dependent mechanism.

Interventions

Argatroban

Argatroban is a synthetic, univalent DTI, that directly binds to the catalytic thrombin binding site exerting its effects

Intervention Type: DRUG

Unfractionated heparin

Unfractionated heparin produces its major anticoagulant effect by inactivating thrombin and activated factor X (factor Xa) through an antithrombin (AT)-dependent mechanism.

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Thomas Staudinger

Prof., MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Staudinger, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

Argatroban_ECMO

Identifier Type: -

Identifier Source: org_study_id