Trials · 2024
Early minimally invasive image-guided endoscopic evacuation of intracerebral hemorrhage (EMINENT-ICH): a randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Hallenberger Tim Jonas, Fischer Urs, Bonati Leo Hermann, Dutilh Gilles, Mucklow Rosine, Vogt Andrea Sarti, Boeni-Eckstein Claudia, Cardia Andrea, Schubert Gerrit A, Bijlenga Phillipe, Messerer Mahmoud, Raabe Andreas, Akeret Kevin, Zweifel Christian, Kuhle Jens, Alfieri Alex, Fournier Jean-Yves, Fandino Javier, Hostettler Isabel Charlotte, Schneider Ulf Christoph, Guzman Raphael, Soleman Jehuda
Аннотация
BACKGROUND: Spontaneous supratentorial intracerebral hemorrhage is the deadliest form of stroke with mortality rates over 50%. Currently, no sufficiently effective treatment to improve both mortality and functional outcome rates exists. However, it seems that minimally invasive surgery, especially endoscopic surgery, might be beneficial in improving survival and functional outcome rates, yet large confirmatory studies thereof are lacking. The aim of this trial is to compare whether early minimally invasive endoscopic surgery leads to improved functional outcome rates compared to the best medical treatment.
METHODS: This is a prospective, parallel-arm, outcome assessor blinded multicenter trial across Switzerland. Endoscopic surgery will be compared to the best medical treatment in a 1:1 randomization over a total time of 12 months. The primary outcome is defined as improved functional outcome (mRS < 3) after 6 months; secondary outcomes include mortality and morbidity rates as well as patient reported outcomes and the temporal evolution of serum biomarkers for brain damage.
DISCUSSION: Currently, large, randomized trials assessing the role and potential effect of early endoscopic surgery in intracerebral hemorrhage are lacking. Potential practical and methodological issues faced in this trial are patient enrollment, adherence to the hematoma evacuation technique used, potential patient cross-over, and the adaptive Bayesian statistical design. Nonetheless, this trial would be among the first to research the effects of early minimally invasive endoscopic surgery for SSICH and can provide class I evidence for future treatment options in intracerebral hemorrhage.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05681988. Registered on January 3, 2023.
METHODS: This is a prospective, parallel-arm, outcome assessor blinded multicenter trial across Switzerland. Endoscopic surgery will be compared to the best medical treatment in a 1:1 randomization over a total time of 12 months. The primary outcome is defined as improved functional outcome (mRS < 3) after 6 months; secondary outcomes include mortality and morbidity rates as well as patient reported outcomes and the temporal evolution of serum biomarkers for brain damage.
DISCUSSION: Currently, large, randomized trials assessing the role and potential effect of early endoscopic surgery in intracerebral hemorrhage are lacking. Potential practical and methodological issues faced in this trial are patient enrollment, adherence to the hematoma evacuation technique used, potential patient cross-over, and the adaptive Bayesian statistical design. Nonetheless, this trial would be among the first to research the effects of early minimally invasive endoscopic surgery for SSICH and can provide class I evidence for future treatment options in intracerebral hemorrhage.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05681988. Registered on January 3, 2023.