Percutaneous versus surgical VA ECMO insertion: a pilot study to evaluate feasibility and safety

• Conditions: acute heart failure; cardiogenic shock; 10019280

• Registration Number: NL-OMON53934
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Age above 18
2. Indication for VA ECMO support (according to international guidelines and as
discussed in our multidisciplinary team)
3. (Deferred) informed consent by proxy

Exclusion Criteria

Patients who are not suitable for undergoing VA ECMO support according to our
standard of practice. In addition, patients undergoing central cannulation in
the operating theatre, are excluded from participation, as well as patients
with no peripheral vascular access

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>Primary efficacy endpoint: procedure success rate, defined as the successful<br /><br>insertion of both arterial and venous cannulas within 3 attempts and subsequent<br /><br>successful initiation of ECMO-flow<br /><br><br /><br>Primary safety objective: is a composite of cannulation-associated adverse<br /><br>events during cannulation, during ECMO and after ECMO decannulation, including:<br /><br>o Vascular complications, defined as development of a false aneurysm,<br /><br>dissection, perforation or another type of vascular damage<br /><br>o Cannulation site bleeding and other major bleeding (BARC type 2 and above)<br /><br>o The development of limb ischemia requiring fasciotomy or amputation<br /><br>o Local infections, defined as a wound culture-proven infection<br /><br>o Systemic infections, defined as blood culture-proven infection</p><br>