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
- Are there results?
- Not yet: the study is under way
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
Show all 10Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06442267
- Acronym / sponsor ID
- CASUAL-ECMO / 1644/2022
- Keywords
- ECMO, Anticoagulation, Thromboembolic Event, Bleeding, extracorporeal life support, anticoagulant, heparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin group | Experimental | Drug: Enoxaparin Injectable SolutionAnticoagulation for the duration of the study will be conducted using subcutaneous Enoxaparin |
| Argatroban group | Experimental | Drug: Argatroban, 1 Mg/mL Intravenous SolutionAnticoagulation for the duration of the study will be conducted using intravenous Argatroban. |
| Unfractionated heparin group | Active comparator | Drug: Unfractionated heparinAnticoagulation for the duration of the study will be conducted using intravenous unfractionated heparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- either
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin Injectable SolutionSubcutaneous Enoxaparin will be dosed at 0.5 mg/kg twice daily | Drug | Enoxaparin group |
| Argatroban, 1 Mg/mL Intravenous SolutionIntravenous 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. | Drug | Argatroban group |
| Unfractionated heparinUnfractionated 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. | Drug | Unfractionated heparin group |
Primary outcome
Incidence of thromboembolic events during ECMO therapy
Time frame: through duration of the ECMO run; an average of 14 days
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
1 secondary outcome
Bleeding events
Time frame: through duration of the ECMO run; an average of 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
Related trials for Respiratory Insufficiency
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johannes Gratz, PD, MD, PhD principal investigator
Medical Univeristy of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincenz Scharner, MD (+43 1 40400 ext. 4100, vincenz.scharner@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of thromboembolic events during ECMO therapy (time frame: through duration of the ECMO run; an average of 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.