RecruitingPhase 4NCT06442267

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 Low-molecular-weight Heparin for Extracorporeal Membrane Oxygenation Support

Sponsor

Medical University of Vienna

Enrollment

90 participants

Start Date

Jul 30, 2024

Study Type

INTERVENTIONAL

Conditions

Bleeding Thromboembolism Respiratory Insufficiency Circulatory Failure

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares three different blood-thinning approaches used to prevent dangerous blood clots forming in the tubing of an ECMO machine — a life support system that pumps and oxygenates blood outside the body for patients with severe heart or lung failure. The three agents compared are heparin (UFH), argatroban, and low-molecular-weight heparin (LMWH). **You may be eligible if...** - You need ECMO (extracorporeal membrane oxygenation) support - OR you have just been placed on ECMO within the last 12 hours **You may NOT be eligible if...** - You have a medical reason you cannot receive any blood thinners - You are pregnant - You have a pre-existing significant blood clotting disorder - Your situation does not allow the study screening and enrollment process Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnoxaparin Injectable Solution

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

DRUGArgatroban, 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.

DRUGUnfractionated 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.

Locations(1)

Medical University of Vienna

Vienna, State of Vienna, Austria

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NCT06442267

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