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Background:
Patients with severe heart and lung failure may be treated with VA-ECMO (veno-arterial extracorporeal membrane oxygenation), a life-support machine that temporarily takes over the function of the heart and lungs. To connect the patient to ECMO, large tubes (cannulas) are inserted into major blood vessels in the groin area.
When the patient no longer needs ECMO, these cannulas must be removed - a process known as decannulation. Closing the artery after removing the cannula is a critical step and can be associated with complications such as bleeding, vessel injury, or blood clots.
Currently, there are different methods to close the artery:
There is no clear standard yet on which method is safest and most effective for ECMO patients.
Purpose of the Study:
The study aims to determine whether using a vascular closure device is as safe and effective as the current standard methods for femoral artery closure after VA-ECMO.
Study Design:
This is a randomized controlled trial. Patients who are scheduled for decannulation after VA-ECMO support will be randomly assigned to one of two groups:
Intervention Group: Patients receive a vascular closure device to seal the artery (Abbott Perclose™ ProStyle™ Suture-Mediated Closure System).
Control Group: Patients receive standard care, which may be either:
This allows for a real-world comparison of the Closure Device method to current clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decannulation using the Perclose™ ProStyle™ | Experimental |
| |
| Standard of Care: Decannulation using surgical removal or manual compression | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decannulation with a medical device | Device | Wound Closure with a medical device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of a combined vessel-orientated clinical endpoint (VOCE) | within 48 hours post ECMO removal |
| Measure | Description | Time Frame |
|---|---|---|
| Length of ICU (intensive care unit) stay post ECMO removal | Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first | |
| Length of hospital stay post ECMO removal | Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jelena Weller | Contact | +49 62159577216 | close-ecmo@ihf.de | |
| Marcel Kunadt, Dr. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Robert Stöhr, PD Dr. Dr. | Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology | Recruiting | Frankfurt | Germany |
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| Decannulation using surgical removal or manual compression | Procedure | Wound closure using surgical removal or manual compression |
|
| Time to mobilization post ECMO removal | Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first |
| Costs of hospital stay | Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first |
| Incidence of Bleeding requiring transfusion (BARC3a) | At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first |
| Vascular complication requiring surgical or interventional therapy | At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first |
| Wound infection requiring antibiotic use or surgical debridement | At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first |
| Rate of pseudoaneurysms as detected by vascular Ultrasound | At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first |
| Rate of veinous thrombosis in the lower vessels as detected by vascular ultrasound | At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first |
| Rate of arterial thrombosis in the lower vessel as detected by vascular ultrasound | At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Zentrum für Kardiologie | Recruiting | Mainz | Germany |