Clinical trial • Phase IV • Respiratory | Infectious Disease | Cardiology

Enoxaparin sodium for Respiratory insufficiency | Respiratory failure | Circulatory failure | Acute respiratory distress syndrome

Phase IV trial of Enoxaparin sodium for Respiratory insufficiency | Respiratory failure | Circulatory failure | Acute respiratory distress syndrome.

Overview

Trial Therapeutic Area: Respiratory | Infectious Disease | Cardiology
Trial Disease: Respiratory insufficiency | Respiratory failure | Circulatory failure | Acute respiratory distress syndrome
Trial Stage: Phase IV
Drug Modality: Other | Small molecule

Key dates

Initial CTIS Submission Date: 29-10-2024
First CTIS Authorization Date: 11-12-2024

Trial design

Randomised, heparin gilvasan 1000 ie/ml – injektions-/infusionslösung (comparator arm): route intravenious infusion; dose unit iu/kg; max daily dose amount 2500 (iu/kg); marketing authorisation 1–12600 (austria). test arms: inhixa 100,000 iu (1000 mg)/10 ml solution for injection in multidose container (enoxaparin sodium): route subcutaneous injection; dose unit mg/kg; max daily dose amount 1 mg/kg; max total dose amount 42 (mg/kg); marketing authorisation eu/1/16/1132/081. argatra multidose 100 mg/ml (argatroban monohydrate): route intravenous infusion; dose unit µg/kg; max daily dose amount 3000 µg/kg; max total dose amount 126000 µg/kg; marketing authorisation 81323.00.00.-controlled Phase IV trial in Austria.

Randomised: Yes
Comparator: Heparin Gilvasan 1000 IE/ml – Injektions-/Infusionslösung (Comparator arm): route INTRAVENIOUS INFUSION; dose unit IU/kg; max daily dose amount 2500 (IU/kg); marketing authorisation 1–12600 (Austria). Test arms: Inhixa 100,000 IU (1000 mg)/10 mL solution for injection in multidose container (Enoxaparin sodium): route SUBCUTANEOUS INJECTION; dose unit mg/kg; max daily dose amount 1 mg/kg; max total dose amount 42 (mg/kg); marketing authorisation EU/1/16/1132/081. Argatra Multidose 100 mg/ml (Argatroban monohydrate): route INTRAVENOUS INFUSION; dose unit µg/Kg; max daily dose amount 3000 µg/Kg; max total dose amount 126000 µg/Kg; marketing authorisation 81323.00.00.
Target Sample Size: 90

Eligibility

Recruits 90 Vulnerable population selected: yes (critically ill ICU patients / ECMO patients). No explicit details on consent or assent handling are provided in the available documents..

Pregnancy Exclusion: Patients who are pregnant
Vulnerable Population: Vulnerable population selected: yes (critically ill ICU patients / ECMO patients). No explicit details on consent or assent handling are provided in the available documents.

Inclusion criteria

{"criterion_text":"- 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

{"criterion_text":"- 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"}
{"criterion_text":"- Patients who are pregnant"}
{"criterion_text":"- Patients suffering from a clinically relevant pre-existing coagulopathy"}
{"criterion_text":"- Patients, for whom screening, randomization and implementation of study protocol cannot be initiated within 12 hours after cannulation"}
{"criterion_text":"- Patients receiving ongoing therapeutic systemic anticoagulation prior to ECMO implantation, or exhibiting an indication for therapeutic anticoagulation (e.g., pulmonary embolism)"}
{"criterion_text":"- Patients whose total duration of ECMO support lasts less than 24 hours"}
{"criterion_text":"- Patients with start of ECMO support during CPR (eCPR)"}
{"criterion_text":"- Patients with passive decarboxylation, without an active pumping system"}
{"criterion_text":"- Patients, who have been weaned off ECMO support within the last 30 days"}
{"criterion_text":"- Patients with central ECMO cannulation and/or after cardiopulmonary bypass"}

Endpoints

Primary endpoints

{"endpoint_text":"- 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","definition_or_measurement_approach":"Clinically relevant thromboembolic events identified by clinical suspicion with confirmation via imaging; includes pulmonary embolism, deep vein thrombosis (including detection during daily routine sonography), intracardiac thrombosis, arterial thromboembolism (myocardial and cerebral infarction), and need to exchange ECMO circuit due to acute or incipient clotting."}

Secondary endpoints

{"endpoint_text":"- Incidence of bleeding events classified according to BARC Criteria","definition_or_measurement_approach":"Bleeding events will be classified according to BARC criteria."}

Recruitment

Planned Sample Size: 90
Recruitment Window Months: 26
Consent Approach: Not specified in the available documents.

Geography

Total Number Of Sites: 1
Total Number Of Participants: 90

Austria

Earliest CTIS Part Ii Submission Date: 19-11-2024
Latest Decision Or Authorization Date: 11-12-2024
Processing Time Days: 22
Number Of Sites: 1
Number Of Participants: 90

Sites

Site Name: Medical University Of Vienna
Department Name: Division of General Anaesthesia and Intensive Care Medicine
Contact Person Name: Johannes Gratz
Contact Person Email: johannes.gratz@meduniwien.ac.at
Number Of Participants: 90

Sponsor

Primary sponsor

Full Name: Medical University Of Vienna
Organisation Type: Educational Institution
Country Of Registered Address: Austria

Third parties

{"country":"","full_name":"European Society of Intensive Care Medicine (ESICM)","duties_or_roles":"Monetary support","organisation_type":""}

Investigational products

Investigational Product Name: Inhixa 100,000 IU (1000 mg)/10 mL solution for injection in multidose container
Active Substance: Enoxaparin sodium
Modality: Other
Routes Of Administration: SUBCUTANEOUS INJECTION
Route: SUBCUTANEOUS INJECTION
Authorisation Status: Authorised (EU/1/16/1132/081)
Maximum Dose: 42 mg/kg

Investigational Product Name: Heparin Gilvasan 1000 IE/ml – Injektions-/Infusionslösung
Active Substance: Heparin sodium
Modality: Other
Routes Of Administration: INTRAVENIOUS INFUSION
Route: INTRAVENIOUS INFUSION
Authorisation Status: Authorised (marketing authorisation 1–12600, Austria)
Maximum Dose: 105000 IU/kg

Investigational Product Name: Argatra Multidose 100 mg/ml Konzentrat zur Herstellung einer Infusionslösung.
Active Substance: Argatroban monohydrate
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: INTRAVENOUS INFUSION
Authorisation Status: Authorised (marketing authorisation 81323.00.00)
Maximum Dose: 126000 µg/Kg

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