TY - JOUR
T1 - Early initiation of extracorporeal life support in refractory out-of-hospital cardiac arrest
T2 - Design and rationale of the INCEPTION trial
AU - Bol, Martine E.
AU - Suverein, Martje M.
AU - Lorusso, Roberto
AU - Delnoij, Thijs S. R.
AU - Bruinsma, George J. Brandon Bravo
AU - Otterspoor, Luuk
AU - Kuijpers, Marijn
AU - Lam, Ka Yan
AU - Vlaar, Alexander P. J.
AU - Kraemer, Carlos V. Elzo
AU - van der Heijden, Joris J.
AU - Scholten, Erik
AU - Driessen, Antoine H. G.
AU - Cabezas, Jose M. Montero
AU - Rittersma, Saskia Z. H.
AU - Heijnen, Bram G.
AU - Taccone, Fabio S.
AU - Essers, Brigitte
AU - Delhaas, Tammo
AU - Weerwind, Patrick W.
AU - Roekaerts, Paul M. H. J.
AU - Maessen, Jos G.
AU - van de Poll, Marcel C. G.
N1 - Funding Information:
This work is funded by “The Netherlands Organization for Health Research and Development” (ZonMw-doelmatigheid, nr 80–84,300–98-71,040). The Getinge Group (Göteborg, Sweden) supplies HLS advanced circuits for all patients undergoing ECPR in the ECPR arm of the trial and 4 loaner Cardiohelp systems to the three sites of the initial consortium for the duration of the trial. The industrial sponsor has no influence on study design, data analyses, interpretation and disclosure of data. The authors are solely responsible for the design and conduct of this study, the study analyses, the drafting and editing of the manuscript, and its final contents.
Publisher Copyright:
© 2018 The Author(s)
PY - 2019/4
Y1 - 2019/4
N2 - Background Return of spontaneous circulation occurs in less than 10% of patients with cardiac arrest undergoing cardiopulmonary resuscitation (CPR) for more than 15 minutes. Studies suggest that extracorporeal life support during cardiopulmonary resuscitation (ECPR) improves survival rate in these patients. These studies, however, are hampered by their non-randomized, observational design and are mostly single-center. A multicenter, randomized controlled trial is urgently warranted to evaluate the effectiveness of ECPR.Hypothesis We hypothesize that early initiation of ECPR in refractory out-of-hospital cardiac arrest (OHCA) improves the survival rate with favorable neurological status.Study design The INCEPTION trial is an investigator-initiated, prospective, multicenter trial that will randomly allocate 110 patients to either continued CPR or ECPR in a 1: 1 ratio. Patients eligible for inclusion are adults (Summary The INCEPTION trial aims to determine the clinical benefit for the use of ECPR in patients with refractory OHCA presenting with VF/VT. Additionally, the feasibility and cost-effectiveness of ECPR will be evaluated.
AB - Background Return of spontaneous circulation occurs in less than 10% of patients with cardiac arrest undergoing cardiopulmonary resuscitation (CPR) for more than 15 minutes. Studies suggest that extracorporeal life support during cardiopulmonary resuscitation (ECPR) improves survival rate in these patients. These studies, however, are hampered by their non-randomized, observational design and are mostly single-center. A multicenter, randomized controlled trial is urgently warranted to evaluate the effectiveness of ECPR.Hypothesis We hypothesize that early initiation of ECPR in refractory out-of-hospital cardiac arrest (OHCA) improves the survival rate with favorable neurological status.Study design The INCEPTION trial is an investigator-initiated, prospective, multicenter trial that will randomly allocate 110 patients to either continued CPR or ECPR in a 1: 1 ratio. Patients eligible for inclusion are adults (Summary The INCEPTION trial aims to determine the clinical benefit for the use of ECPR in patients with refractory OHCA presenting with VF/VT. Additionally, the feasibility and cost-effectiveness of ECPR will be evaluated.
KW - CONVENTIONAL CARDIOPULMONARY-RESUSCITATION
KW - COUNCIL GUIDELINES
KW - DEFERRED CONSENT
KW - CARE
KW - SURVIVAL
KW - ADULTS
U2 - 10.1016/j.ahj.2018.12.008
DO - 10.1016/j.ahj.2018.12.008
M3 - Article
C2 - 30738245
SN - 0002-8703
VL - 210
SP - 58
EP - 68
JO - American Heart Journal
JF - American Heart Journal
ER -