Comparing Anticoagulation Strategies using Unfractionated heparin, Argatroban and Low-molecular-weight heparin for Extracorporeal Membrane (CASUAL ECMO)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Virus Diseases [C02], Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

17 Jun 2024 → ongoing

Decision date (initial)

2024-12-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

European Society of Intensive Care Medicine (ESICM)

External identifiers

EU CT number

2024-518702-40-00

EudraCT number

2022-002259-20

ClinicalTrials.gov

NCT06442267

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary outcome of this study will be to assess the difference in the occurrence of thromboembolic
events during ECMO therapy depending on the three different anticoagulants used. The comparison will
be calculated between both the low-molecular heparin (LMWH) Enoxaparin as well as the direct thrombin
inhibitor (DTI) Argatroban and the current recommendation of the ELSO unfractionated heparin (UFH).

Secondary objectives 1

1. Secondary outcomes of this study focus on the safety of using LMWH or Argatroban in comparison with UFH for anticoagulation during ECMO. We will thus investigate the potential impact of the three different anticoagulants on the incidence of bleeding events (classified by the BARC criteria). We expect that the incidence of bleeding events and transfusion of blood products will be equal or reduced in the LMWH and Argatroban group in comparison with UFH, defined by a 10% non-inferiority margin.

Conditions and MedDRA coding

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. atients at the following ICUs of the MUV (13C1, 13C2, 9D, 13B1, 13I1, A7) 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

Exclusion criteria 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 1

1. Incidence of bleeding events classified according to BARC Criteria

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Division of General Anaesthesia and Intensive Care Medicine

Public contact point

Organisation

Medical University Of Vienna

Contact name

Division of General Anaesthesia and Intensive Care Medicine

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications