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

Overview

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.

Interventions

• Device Decannulation with a medical device
  Wound Closure with a medical device
• Procedure Decannulation using surgical removal or manual compression
  Wound closure using surgical removal or manual compression

Primary outcome measures

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

Secondary outcome measures (10)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 2 centers

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

Identifiers

NCT: NCT07019662 · MDR-004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗