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Compares treatment options for Respiratory Insufficiency
Official title Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support
ClinicalTrials.gov ID: NCT06442267
What this study is testing
What is Enoxaparin Injectable Solution?
Enoxaparin Injectable Solution is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for respiratory insufficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- either
- require ECMO support or
- have been started on ECMO therapy within the last 12 hours
You likely can't join if
- 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...
- Patients whose total duration of ECMO support lasts less than 24 hours
See the full eligibility criteria
- either
- require ECMO support or
- have been started on ECMO therapy within the last 12 hours
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, State of Vienna, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, State of Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.