Protocol and Statistical Analysis Plan for the ECMO-Free Trial: A Multicenter Randomized Controlled Trial

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.

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.

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?

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.

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.

ClinicalTrials.gov ; No. NCT05486559 ; URL: www.clinicaltrials.gov.