Early minimally invasive image-guided endoscopic evacuation of intracerebral hemorrhage (EMINENT-ICH): a randomized controlled trial

被引：3

作者：

Hallenberger, Tim Jonas ^{[1
,2
]}

Fischer, Urs ^{[2
,3
]}

Bonati, Leo Hermann ^{[4
]}

Dutilh, Gilles ^{[5
]}

Mucklow, Rosine ^{[6
]}

Vogt, Andrea Sarti ^{[1
]}

Boeni-Eckstein, Claudia ^{[1
]}

Cardia, Andrea ^{[7
]}

Schubert, Gerrit A. ^{[8
]}

Bijlenga, Phillipe ^{[9
]}

Messerer, Mahmoud ^{[10
]}

Raabe, Andreas ^{[11
]}

Akeret, Kevin ^{[12
]}

Zweifel, Christian ^{[2
,13
]}

Kuhle, Jens ^{[3
,14
]}

Alfieri, Alex ^{[15
,16
]}

Fournier, Jean-Yves ^{[17
]}

Fandino, Javier ^{[18
]}

Hostettler, Isabel Charlotte ^{[19
]}

Schneider, Ulf Christoph

Guzman, Raphael ^{[1
,2
,14
]}

Soleman, Jehuda ^{[1
,2
]}

机构：

[1] Univ Hosp Basel, Dept Neurosurg, Spitalstr 21, CH-4031 Basel, Switzerland

[2] Univ Basel, Fac Med, Klingelbergstr 61, CH-4056 Basel, Switzerland

[3] Univ Basel, Univ Hosp Basel, Dept Neurol, Petersgraben 4, CH-4031 Basel, Switzerland

[4] Reha Rheinfelden, Salinenstr 98, CH-4310 Rheinfelden, Switzerland

[5] Univ Basel Hosp, Div Oncol, CH-4031 Basel, Switzerland

[6] BioFocus, CH-4123 Allschwil, Switzerland

[7] Reg Hosp Lugano, Neuroctr Southern Switzerland, Dept Neurosurg, Via Tesserete 46, CH-6900 Lugano, Switzerland

[8] Kantonsspital Aarau, Dept Neurosurg, Tellstr 25, CH-5001 Aarau, Switzerland

[9] Univ Hosp Geneva, Dept Anaesthesiol, Geneva, Switzerland

[10] Univ Lausanne Hosp CHUV, Dept Neurosurg, Rue Bugnon 46, CH-1011 Lausanne, Switzerland

[11] Univ Hosp Bern, Dept Neurosurg, Freiburgstr 10, CH-3010 Bern, Switzerland

[12] Univ Zurich, Univ Zurich Hosp, Dept Neurosurg, Clin Neurosci Ctr, CH-8091 Zurich, Switzerland

[13] Kantonsspital Graubunden, Loestr 170, CH-7000 Chur, Switzerland

[14] Univ Hosp Basel, Multiple Sclerosis Ctr, Res Ctr Clin Neuroimmunol & Neurosci RC2NB, Dept Biomed & Clin Res,Neurol, Basel, Switzerland

[15] Kantonsspital Winterthur, Dept Neurosurg, Brunngasse 30, CH-8401 Winterthur, Switzerland

[16] Univ Svizzera Italiana USI, Fac Biomed Sci, Via Giuseppe Buffi 13, CH-6900 Lugano, Switzerland

[17] Valais Hosp, Dept Gynecol & Obstet, Ave Grand Champsec 80, CH-1951 Sion, Switzerland

[18] Klin Hirslanden, Witellikerstr 40, CH-8008 Zurich, Switzerland

[19] Kantonsspital St Gallen, Dept Neurosurg, Rorschacherstr 95, CH-9007 St Gallen, Switzerland

来源：

TRIALS | 2024年 / 25卷 / 01期

基金：

芬兰科学院; 瑞士国家科学基金会;

关键词：

Minimally invasive surgery; Endoscopic surgery; Intracerebral hemorrhage; Functional outcome; Patient reported outcome measures; Bayesian design; Study protocol; INITIAL CONSERVATIVE TREATMENT; MODIFIED RANKIN SCALE; EARLY SURGERY; STROKE; SERUM; BLOOD; VALIDATION; BIOMARKERS; MANAGEMENT; HEMATOMAS;

D O I：

10.1186/s13063-024-08534-7

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页数：21

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