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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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518702-40-00
Enrollment
90
Registered
2024-12-11
Start date
2024-06-17
Completion date
Unknown
Last updated
2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Circulatory Failure, Respiratory Failure, Respiratory Insufficiency

Brief summary

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 acute or incipient clotting

Detailed description

Incidence of bleeding events classified according to BARC Criteria

Interventions

DRUGHeparin Gilvasan 1000 IE/ml – Injektions-/Infusionslösung
DRUGInhixa 100
DRUG000 IU (1000 mg)/10 mL solution for injection in multidose container
DRUGArgatra Multidose 100 mg/ml Konzentrat zur Herstellung einer Infusionslösung.

Sponsors

Medical University Of Vienna
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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 acute or incipient clotting

Secondary

MeasureTime frame
Incidence of bleeding events classified according to BARC Criteria

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026