Protocol and Statistical Analysis Plan for the ECMO-Free Trial

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ABSTRACT Take-Home Points Study Question Does a daily protocolized assessment of readiness for decannulation from venovenous extracorporeal membrane oxygenation (V-V ECMO) shorten the time to decannulation? Results This manuscript describes the protocol and statistical analysis plan for the ECMO-Free Trial, a multicenter randomized trial comparing a protocolized assessment of readiness to decannulate from ECMO versus usual care. Interpretation Specifying the protocol and full statistical analysis plan before completion of enrollment increases rigor, reproducibility, and transparency of trial results. Background Decannulation from venovenous extracorporeal membrane oxygenation (V-V ECMO) at the earliest, safe opportunity would be expected to improve patient outcomes. Currently, the manner in which clinicians liberate patients from V-V ECMO is highly variable. Whether performing a daily protocolized assessment of readiness for decannulation decreases the time to decannulation for patients on V-V ECMO is unknown. Research Question Does the performance of a daily protocolized assessment of readiness to decannulate from ECMO (an “ECMO-free protocol”) decrease the time to successful decannulation compared to usual care among patients receiving V-V ECMO? Study Design and Methods The ECMO-Free Trial is a pragmatic, multicenter, unblinded, parallel-group, randomized trial being conducted in 7 sites in North America. The trial compares the daily performance of an ECMO-free protocol in which patients who meet safety criteria have their sweep gas flow rate turned to 0 liters per minute (simulating the patient being “off ECMO”) to usual care among 225 adults receiving V-V ECMO. The primary outcome is the time to successful decannulation from ECMO within 60 days. The secondary outcome is the number of ECMO-free days to day 60. Enrollment began on September 7, 2022, and is expected to conclude in 2026. Interpretation The ECMO-Free Trial will provide important data on the effects of a protocolized assessment of readiness to decannulate vs usual care on the time to decannulation and other outcomes among patients receiving V-V ECMO. Specifying the protocol and statistical analysis plan before the conclusion of enrollment increases the rigor, reproducibility, and transparency of the trial. Trial Registry ClinicalTrials.gov ; No. NCT05486559 ; URL: www.clinicaltrials.gov

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