Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO

NCT05226442 | Completed Phase 2 FDA Drug

• 1 other identifier: Argatroban_ECMO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Bleeding and thrombosis with Argatroban compared to unfractionated Heparin (UFH)

  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

  From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days

Secondary Outcomes (1)

• 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

Other Outcomes (3)

• Transfusion rate of packed red blood cells assessed as total units/ECMO day

  From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days

• Grading of bleeding

  From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days

• Mortality rate at day 28/90

  Until 90 days after start of study drug administration

Study Arms (2)

Argatroban

EXPERIMENTAL

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

Drug: Argatroban

Unfractionated Heparin

ACTIVE COMPARATOR

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.

Drug: Unfractionated heparin

Interventions

Argatroban DRUG

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

Argatroban

Unfractionated heparin DRUG

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

Unfractionated Heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hemostatic Disorders

Interventions

argatroban; Heparin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Thomas Staudinger, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD

Model Details: Randomization ratio of 1:1 for anticoagulation with Argatroban or Unfractionated Heparin

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: February 7, 2022
• Study Start: December 1, 2021
• Primary Completion: July 7, 2024
• Study Completion: July 7, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)