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

NCT06442267 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-10-29

No results posted yet for this study

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

Interventions

DRUG

Enoxaparin Injectable Solution

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

DRUG

Argatroban, 1 Mg/mL Intravenous Solution

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.

DRUG

Unfractionated heparin

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.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Johannes Gratz, PD, MD, PhD · Medical Univeristy of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-30
Primary Completion
2027-01-30
Completion
2027-07-30

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06442267 on ClinicalTrials.gov