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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53934

Enrollment

Registered

2023-03-03

Start date

2022-12-01

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute heart failure cardiogenic shock

Interventions

Percutaneous insertion of ECMO cannulas

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary study parameters/endpoints Separate analysis of the components of the composite endpoint: o Vascular complications, which is defined as the development of a false aneurysm, dissection, perforation or another type of vascular damage o Cannulation site bleeding and other major bleeding (BARC type 2 and above) o The development of limb ischemia requiring fasciotomy or amputation o Local infections, defined as a wound culture-proven infection o Systemic infections, defined as blood culture-proven infection As well as: - Thirty-day mortality - Cross-over rate due to failed cannulation - Procedure time, defined as time from first puncture/incision to the moment of ECMO-flow initiation - Number of attempts with successful puncture, but failure to advance the wire - Number of failed percutaneous attempts, defined as wire insertion without successful cannulation	—

Measure

Time frame

Secondary study parameters/endpoints Separate analysis of the components of the composite endpoint: o Vascular complications, which is defined as the development of a false aneurysm, dissection, perforation or another type of vascular damage o Cannulation site bleeding and other major bleeding (BARC type 2 and above) o The development of limb ischemia requiring fasciotomy or amputation o Local infections, defined as a wound culture-proven infection o Systemic infections, defined as blood culture-proven infection As well as: - Thirty-day mortality - Cross-over rate due to failed cannulation - Procedure time, defined as time from first puncture/incision to the moment of ECMO-flow initiation - Number of attempts with successful puncture, but failure to advance the wire - Number of failed percutaneous attempts, defined as wire insertion without successful cannulation

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)