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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-30

Study Completion Date

2027-07-30

Brief Summary

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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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Detailed Description

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Conditions

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Respiratory Insufficiency Circulatory Failure Thromboembolism Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Enoxaparin group

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

Group Type EXPERIMENTAL

Enoxaparin Injectable Solution

Intervention Type DRUG

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

Argatroban group

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

Group Type EXPERIMENTAL

Argatroban, 1 Mg/mL Intravenous Solution

Intervention Type 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 group

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

Group Type ACTIVE_COMPARATOR

Unfractionated heparin

Intervention Type 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.

Interventions

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Enoxaparin Injectable Solution

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No