Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach

Обзор

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: * Surgical closure: open surgery to directly suture the artery * Manual compression: pressing on the artery to stop bleeding * Vascular closure devices (VCDs): special tools that close the artery through the skin 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: * Manual compression, or * Surgical closure, depending on the treating physician's judgment and the patient's condition. This allows for a real-world comparison of the Closure Device method to current clinical practice.

Вмешательства

• Устройство Decannulation with a medical device
  Wound Closure with a medical device
• Процедура Decannulation using surgical removal or manual compression
  Wound closure using surgical removal or manual compression

Первичные конечные точки

• Incidence of a combined vessel-orientated clinical endpoint (VOCE) [Срок оценки: within 48 hours post ECMO removal]

Вторичные конечные точки (10)

• Length of ICU (intensive care unit) stay post ECMO removal [Срок оценки: Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first]
• Length of hospital stay post ECMO removal [Срок оценки: Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first]
• Time to mobilization post ECMO removal [Срок оценки: Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first]
• Costs of hospital stay [Срок оценки: Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first]
• Incidence of Bleeding requiring transfusion (BARC3a) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first]

Критерии участия

Критерии включения

• Age ≥ 18 Years
• Femoral placement of VA-ECMO with peripheral, percutaneous cannulation
• Arterial puncture site above the femoral bifurcation
• Cannula size must match or be smaller than the maximally licensed diameter for Perclose™ ProStyle™ (26 F (French) outer diameter arterial and 29 F outer diameter veinous)
• Patients must be eligible for either the Perclose™ ProStyle™ device or one of the two guideline-compliant alternatives for ECMO cannula removal (manual compression or surgical closure) according to the investigator's judgment.
• Initial arterial and/or venous puncture for ECMO cannulation was performed using ultrasound guidance with corresponding documentation available in the patient record.

Критерии исключения

• Severe calcification
• Surgical cannulation
• Ongoing Infection of the ECMO site
• Any patient who does not fullfil the eligibility criteria for the use of the study device according to its current Instructions for Use (IFU), including known contraindications, limitations or warnings.
• Participation in another interventional clinical trial.
• Patients who are pregnant (assessed by clinical routine testing) or lactating.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 2 центра

• Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiol — Frankfurt
• Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Zentrum für Kardiologie — Mainz

Идентификаторы

NCT: NCT07019662 · MDR-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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