Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial.
Messika, J., et alBMJ Open 2024; 14(3): e077770
Aims
This protocol for a randomised controlled trial aims to compare ‘systematic’ versus ‘on-demand’ venoarterial extracorporeal membrane oxygenation (VA-ECMO) initiation strategies during the perioperative period in patients with obstructive or restrictive lung disease that are in need of bilateral lung transplantation.
Interventions
Participants will be randomised to two groups: the experimental ‘systematic’ group, where VA-ECMO will be initiated pre-emptively; and the control ‘on-demand’ group, in which VA-ECMO initiation will be based on high haemodynamic and respiratory needs.
Participants
Adult patients (≥18 years of age) with chronic obstructive pulmonary disease (COPD)/ emphysema or interstitial lung disease (ILD) that are being assessed for sequential double transplantation (SDLTx).
Outcomes
The primary outcome is number of ventilator-free days. The main secondary outcomes include occurrence of organ failure, vital status and adverse events.
Follow-up
1 year posttransplantation
CET Conclusions
The use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) during lung transplantation has been shown to improve cardiopulmonary haemodynamics but also causes increased inflammation and bleeding. There is controversy surrounding the strategy which would best balance these risks and benefits. On-demand strategies, where VA-ECMO is initiated only when deteriorating haemodynamic or respiratory parameters require, and systematic strategies, where VA-ECMO is employed routinely before pulmonary artery cross-clamping, have been compared in retrospective analyses with mixed results. Selection bias is a major problem with these retrospective analyses, as patients who require VA-ECMO in an on-demand setting are generally in a worse clinical condition. The proposed study aims to address the shortcomings of previous work by comparing these two strategies in a randomised control trial. The primary outcome is the number of ventilator free days in the first 28 days post-operatively. Secondary outcomes include graft failure rate and other adverse events. The authors hypothesise that the systematic strategy is superior and will reduce the need for mechanical ventilation without increasing the rate of adverse events.
Trial registration
ClinicalTrials.gov - NCT05664204