Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO

Medical University of Vienna40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Extracorporeal Membrane Oxygenation Complication Anticoagulants and Bleeding Disorders

Interventions

ArgatrobanDRUG

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

Unfractionated heparinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Medical University of Vienna

Vienna, Vienna, Austria

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

study enrollment, study completion and ability to achieve target values of Argatroban as anticoagulant in ECMO

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.