Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support (CASUAL-ECMO)

Medical University of Vienna

Status and phase: Enrolling; Phase 4

Conditions: Thromboembolism; Respiratory Insufficiency; Circulatory Failure; Bleeding

Treatments: Drug: Argatroban, 1 Mg/mL Intravenous Solution; Drug: Enoxaparin Injectable Solution; Drug: Unfractionated heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT06442267

1644/2022

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Enoxaparin group

Experimental group

Description:

Anticoagulation for the duration of the study will be conducted using subcutaneous Enoxaparin

Treatment:

Drug: Enoxaparin Injectable Solution

Argatroban group

Experimental group

Description:

Anticoagulation for the duration of the study will be conducted using intravenous Argatroban.

Treatment:

Drug: Argatroban, 1 Mg/mL Intravenous Solution

Unfractionated heparin group

Active Comparator group

Description:

Anticoagulation for the duration of the study will be conducted using intravenous unfractionated heparin

Treatment:

Drug: Unfractionated heparin