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NCT Number: NCT05226442

Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO

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.

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Key information

Conditions

Extracorporeal Membrane Oxygenation Complication Anticoagulants and Bleeding Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Argatroban

Drug

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

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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

Other outcomes

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

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

    Assessment of the total amount of units (250-300ml each) packed red blood cells transfused per ECMO day following a transfusion threshold of Hb<8g/dl

  2. Grading of bleeding

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

    According to the Bleeding Academic Research Consortium type 1 - 5 (Type 1: Bleeding that is not actionable; Type 2: Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional; Type 3a. Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding; Type 3b. Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents; type 3c. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision; Type 4: CABG-related bleeding within 48 hours; Type 5a. Probable fatal bleeding; Type 5b. Definite fatal bleeding (overt or autopsy or imaging confirmation)

  3. Mortality rate at day 28/90

    Time frame: Until 90 days after start of study drug administration

    assessed by chart review or telephone call

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

A Prospective Randomized Pilot Trial on Safety and Feasibility of Argatroban As Anticoagulant in Patients with Extracorporeal Membrane Oxygenation (ECMO)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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