TY - JOUR
T1 - Reduced anticoagulation targets in extracorporeal life support (RATE)
T2 - protocol for a pre-planned secondary Bayesian analysis of the rate trial
AU - van Minnen, Olivier
AU - Linde, Maximilian
AU - Lansink-Hartgring, Annemieke Oude
AU - van den Boogaard, Bas
AU - Bunge, Jeroen J. H.
AU - Delnoij, Thijs S. R.
AU - Kraemer, Carlos V. Elzo
AU - Kuijpers, Marijn
AU - Maas, Jacinta J.
AU - de Metz, Jesse
AU - van de Poll, Marcel
AU - Miranda, Dinis dos Reis
AU - Vlaar, Alexander P. J.
AU - van Ravenzwaaij, Don
AU - van den Bergh, Walter M.
PY - 2025/3/15
Y1 - 2025/3/15
N2 - BackgroundThe RATE trial is a three-arm non-inferiority randomized controlled trial in adult patients treated with extracorporeal membrane oxygenation (ECMO) on the effect of anticoagulation levels on mortality, hemorrhagic, and thrombotic complications. The current protocol presents the rationale and analysis plan for evaluating the primary and secondary outcomes under the Bayesian framework.MethodsThis protocol was drafted and submitted before study completion and, thus, the primary analysis. The primary outcome of the Bayesian analysis is mortality at 6 months. The secondary outcomes are severe hemorrhagic and thrombotic complications. We will use an uninformative prior for the primary analysis. Sensitivity analyses will be performed using a skeptical prior and an evidence-based informative prior.ConclusionThe proposed secondary, pre-planned Bayesian analysis of the RATE trial will provide additional information on the effect of different anticoagulation strategies during ECMO on complication rates. This additional Bayesian analysis will likely increase the validity of our results and complement the interpretation of the primary and several secondary outcomes.Trial registrationThis trial is registered at https://clinicaltrials.gov/ (NCT04536272), registration date September 2, 2020. This trial is also registered at the Dutch trial register (NL7976).
AB - BackgroundThe RATE trial is a three-arm non-inferiority randomized controlled trial in adult patients treated with extracorporeal membrane oxygenation (ECMO) on the effect of anticoagulation levels on mortality, hemorrhagic, and thrombotic complications. The current protocol presents the rationale and analysis plan for evaluating the primary and secondary outcomes under the Bayesian framework.MethodsThis protocol was drafted and submitted before study completion and, thus, the primary analysis. The primary outcome of the Bayesian analysis is mortality at 6 months. The secondary outcomes are severe hemorrhagic and thrombotic complications. We will use an uninformative prior for the primary analysis. Sensitivity analyses will be performed using a skeptical prior and an evidence-based informative prior.ConclusionThe proposed secondary, pre-planned Bayesian analysis of the RATE trial will provide additional information on the effect of different anticoagulation strategies during ECMO on complication rates. This additional Bayesian analysis will likely increase the validity of our results and complement the interpretation of the primary and several secondary outcomes.Trial registrationThis trial is registered at https://clinicaltrials.gov/ (NCT04536272), registration date September 2, 2020. This trial is also registered at the Dutch trial register (NL7976).
KW - CLINICAL-TRIALS
U2 - 10.1186/s13063-025-08737-6
DO - 10.1186/s13063-025-08737-6
M3 - Article
SN - 1745-6215
VL - 26
JO - Trials
JF - Trials
IS - 1
M1 - 90
ER -