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NCT Number: NCT06442267

Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support

A three-arm randomized controlled non-inferiority pilot study comparing anticoagulation strategies using unfractionated heparin, argatroban and enoxaparin for extracorporeal membrane oxygenation support conducted as an investigator-initiated, prospective, parallel group, open-label, active comparator controlled, single center, phase IV study to evaluate the non-inferiority of enoxaparin or argatroban for anticoagulation during ECMO therapy in comparison to the current standard, unfractionated heparin, as measured by the incidence of thromboembolic events during the duration of ECMO therapy

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Key information

Conditions

Respiratory Insufficiency Bleeding Cardiovascular Diseases Circulatory Failure Embolism and Thrombosis Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Shock Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Location status: Recruiting

Location contact

Vincenz Scharner, Dr. med.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • either
  • require ECMO support or
  • have been started on ECMO therapy within the last 12 hours

Exclusion criteria

  • Patients exhibiting contraindications to anticoagulation in general or any of the three investigated substances
  • Patients who are pregnant
  • Patients suffering from a clinically relevant pre-existing coagulopathy
  • Patients, for whom screening, randomization and implementation of study protocol cannot be initiated within 12 hours after cannulation
  • Patients receiving ongoing therapeutic systemic anticoagulation prior to ECMO implantation, or exhibiting an indication for therapeutic anticoagulation (e.g., pulmonary embolism)
  • Patients whose total duration of ECMO support lasts less than 24 hours
  • Patients with start of ECMO support during CPR (eCPR)
  • Patients with passive decarboxylation, without an active pumping system
  • Patients, who have been weaned off ECMO support within the last 30 days
  • Patients with central ECMO cannulation and/or after cardiopulmonary bypass

Treatment and study plan

Enoxaparin Injectable Solution

Drug

Subcutaneous Enoxaparin will be dosed at 0.5 mg/kg twice daily

Argatroban, 1 Mg/mL Intravenous Solution

Drug

Intravenous Argatroban will be administered as a continuous infusion of 0.1-1 µg/kg/min with a target modified thrombin time measured using Hemoclot of 0,40 - 0,60 µg/mL.

Unfractionated heparin

Drug

Unfractionated heparin will be administered as a continuous infusion of 7.5-20 units/kg/h with a target Anti FXa calibrated for UFH of 0.3-0.5 u/mL.

Primary outcomes

  1. Incidence of thromboembolic events during ECMO therapy

    Time frame: through duration of the ECMO run; an average of 14 days

    Clinically relevant thromboembolic events (Clinical suspicion; confirmation via imaging)

    • Pulmonary embolism, deep vein thrombosis
    • Intracardiac thrombosis
    • Arterial thromboembolism including myocardial and cerebral infarction
    • Deep vein thrombosis (detected during daily routine sonography)
    • Need to exchange ECMO circuit due to acute or incipient clotting

Secondary outcomes

  1. Bleeding events

    Time frame: through duration of the ECMO run; an average of 14 days

    Incidence of bleeding events classified according to BARC Criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Vincenz Scharner, MD

CONTACT

[email protected]

+43 1 40400 ext. 4100

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

A Three-arm Randomized Controlled Non-inferiority Pilot Study Comparing Anticoagulation Strategies Using Unfractionated Heparin, Argatroban and Low-molecular-weight Heparin for Extracorporeal Membrane Oxygenation Support

Acronym: CASUAL-ECMO

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2024
Registry last updated
Oct 29, 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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