patients with indication for extracorporeal membrane oxygenation therapy
Conditions
Interventions
Trade Name: Inhixa
Product Name: Enoxaparin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Enoxaparin sodium
CAS Number: 9041-08-1
Concentration unit: IU international unit(s)
Concen
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients at ICUs of the MUV will be included if they are older than 18 years and either • require ECMO support or • have been started on ECMO therapy within the last 12 hours Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Patients exhibiting contraindications to anticoagulation in general or any of the three investigated substances, including clinician’s decision to conduct ECMO support without anticoagulation due to extreme bleeding risk or if the clinician determines that the patient’s condition necessitates a specific approach to anticoagulation during ECMO support • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ;Secondary Objective: Safety Objectives •To assess the safety and tolerability of Enoxaparin or Argatroban in patients with need for ECMO support in terms of the incidence of bleeding events classified according to Bleeding Academic Research Council Criteria Exploratory Objectives (in comparison with unfractionated heparin) •To assess the impact of anticoagulation using Enoxaparin or Argatroban during ECMO support on the frequency of transfusions of blood or blood-derived products •To assess the effect of anticoagulation with Enoxaparin or Argatroban during ECMO support on daily serum hemoglobin levels and platelet count •To assess the percentage of coagulation tests within target range for anticoagulation with Enoxaparin or Argatroban •To assess the impact of anticoagulation using Enoxaparin or Argatroban during ECMO support on the length of ICU stay •To assess the impact of anticoagulation using Enoxaparin or Argatroban during ECMO support on mortality during the ICU stay;Primary end point(s): Incidence of thromboembolic events during ECMO therapy i.e.: •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 clotting;Timepoint(s) of evaluation of this end point: continuous evaluation, daily screening, final tabulation at end of ECMO therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Incidence of bleeding events classified according to BARC Criteria ;Timepoint(s) of evaluation of this end point: continuous evaluation, daily screening, final tabulation at end of ECMO therapy | — |
Countries
Austria
Contacts
Public ContactClinical Trials Information officer
Medical University of Vienna
Outcome results
None listed