Respiratory InsufficiencyPhase 4CASUAL-ECMONCT06442267
Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support
A Phase 4 study testing Enoxaparin Injectable Solution, Argatroban, 1 Mg/mL Intravenous Solution and Unfractionated heparin in people with Respiratory Insufficiency and Circulatory Failure, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Circulatory Failure, Thromboembolism
- What is being tested?
- Enoxaparin Injectable Solution, Argatroban, 1 Mg/mL Intravenous Solution and Unfractionated heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteAustria
- Study dates
- 30 Jul 2024to 30 Jul 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- either
- require ECMO support or
- have been started on ECMO therapy within the last 12 hours
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Vincenz Scharner, Dr. med., vincenz.scharner@meduniwien.ac.at
About this study
Official title: 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
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
- Being tested
- Enoxaparin Injectable Solution, Argatroban, 1 Mg/mL Intravenous Solution, Unfractionated heparin
- Keywords
- ECMO, Anticoagulation, Thromboembolic Event, Bleeding, extracorporeal life support, anticoagulant, heparin
- Medical subject headings
- Respiratory Insufficiency, Shock, Thromboembolism, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin Injectable SolutionDrug
Subcutaneous Enoxaparin will be dosed at 0.5 mg/kg twice daily
Argatroban, 1 Mg/mL Intravenous SolutionDrug
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 heparinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin group | Experimental | Anticoagulation for the duration of the study will be conducted using subcutaneous Enoxaparin Receives: Drug: Enoxaparin Injectable Solution |
| Argatroban group | Experimental | Anticoagulation for the duration of the study will be conducted using intravenous Argatroban. Receives: Drug: Argatroban, 1 Mg/mL Intravenous Solution |
| Unfractionated heparin group | Active comparator | Anticoagulation for the duration of the study will be conducted using intravenous unfractionated heparin Receives: Drug: Unfractionated heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of thromboembolic events during ECMO therapy
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
Measured: through duration of the ECMO run; an average of 14 days
Secondary outcomes (1)
Bleeding events
Incidence of bleeding events classified according to BARC Criteria
Measured: through duration of the ECMO run; an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start30 Jul 2024
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Gratz, Medical University of Vienna
- Investigators
- Johannes Gratz, PD, MD, PhD, Principal investigator, Medical Univeristy of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442267
- Sponsor's protocol ID
- 1644/2022
- Acronym
- CASUAL-ECMO
- Status last verified
- Oct 2024
- First submitted
- 27 May 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No