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

NCT06442267 | Recruiting Phase 4

• 1 other identifier: 1644/2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Insufficiency; Circulatory Failure; Thromboembolism; Bleeding

Keywords

ECMO; Anticoagulation; Thromboembolic Event; Bleeding; extracorporeal life support; anticoagulant; heparin

Outcome Measures

Primary Outcomes (1)

• Incidence of thromboembolic events during ECMO therapy

  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

  through duration of the ECMO run; an average of 14 days

Secondary Outcomes (1)

• Bleeding events

  through duration of the ECMO run; an average of 14 days

Study Arms (3)

Enoxaparin group

EXPERIMENTAL

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

Drug: Enoxaparin Injectable Solution

Argatroban group

EXPERIMENTAL

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

Drug: Argatroban, 1 Mg/mL Intravenous Solution

Unfractionated heparin group

ACTIVE COMPARATOR

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

Drug: Unfractionated heparin

Interventions

Enoxaparin Injectable Solution DRUG

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

Enoxaparin group

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.

Argatroban group

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.

Unfractionated heparin group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Shock; Thromboembolism; Hemorrhage

Interventions

argatroban; Heparin

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Johannes Gratz, PD, MD, PhD

  Medical Univeristy of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenz Scharner, MD

CONTACT

+43 1 40400; vincenz.scharner@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 4, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

AU (1)