. 2024 Oct 18;25(1):692.

doi: 10.1186/s13063-024-08534-7.

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

Tim Jonas Hallenberger^{1

2}, Urs Fischer^{3

4}, Leo Hermann Bonati⁵, Gilles Dutilh⁶, Rosine Mucklow⁷, Andrea Sarti Vogt⁸, Claudia Boeni-Eckstein⁸, Andrea Cardia⁹, Gerrit A Schubert¹⁰, Phillipe Bijlenga¹¹, Mahmoud Messerer¹², Andreas Raabe¹³, Kevin Akeret¹⁴, Christian Zweifel^{3

15}, Jens Kuhle^{4

16}, Alex Alfieri^{17

18}, Jean-Yves Fournier¹⁹, Javier Fandino²⁰, Isabel Charlotte Hostettler²¹, Ulf Christoph Schneider²², Raphael Guzman^{8

3

16}, Jehuda Soleman^{8

3}

Affiliations

¹ Department of Neurosurgery, University Hospital Basel, Spitalstrasse 21, Basel, CH-4031, Switzerland. tim.hallenberger@usb.ch.
² Faculty of Medicine, University of Basel, Klingelbergstrasse 61, Basel, CH-4056, Switzerland. tim.hallenberger@usb.ch.
³ Faculty of Medicine, University of Basel, Klingelbergstrasse 61, Basel, CH-4056, Switzerland.
⁴ Department of Neurology, University Hospital Basel and University of Basel, Petersgraben 4, Basel, CH-4031, Switzerland.
⁵ Reha Rheinfelden, Salinenstrasse 98, Rheinfelden, CH-4310, Switzerland.
⁶ Division of Statistics, Department of Clinical Research, University Hospital Basel, Spitalstrasse 12, Basel, CH-4031, Switzerland.
⁷ Buxtorf Quality Services, Traubenweg 4, Allschwil, CH-4123, Switzerland.
⁸ Department of Neurosurgery, University Hospital Basel, Spitalstrasse 21, Basel, CH-4031, Switzerland.
⁹ Service of Neurosurgery, Neurocenter of the Southern Switzerland, Regional Hospital of Lugano, Ente Ospedaliero Cantonale (EOC), Via Tesserete 46, Lugano, CH-6900, Switzerland.
¹⁰ Department of Neurosurgery, Kantonsspital Aarau, Tellstrasse 25, Aarau, CH-5001, Switzerland.
¹¹ Department of Neurosurgery, University Hospital Geneva, Rue Gabrielle-Perret-Gentil 4, Geneva, CH-1211, Switzerland.
¹² Department of Neurosurgery, University Hospital Lausanne (CHUV), Rue du Bugnon 46, Lausanne, CH-1011, Switzerland.
¹³ Department of Neurosurgery, University Hospital Bern, Freiburgerstrasse 10, Bern, CH-3010, Switzerland.
¹⁴ Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zürich and University of Zürich, Raemistrasse 100, Zurich, CH-8091, Switzerland.
¹⁵ Neurosurgical Unit, Kantonsspital Graubünden, Loestrasse 170, Chur, CH-7000, Switzerland.
¹⁶ Multiple Sclerosis Centre and Research Center for Clinical Neuroimmunology and Neuroscience (RC2NB), Departments of Biomedicine and Clinical Research, University Hospital Basel and University of Basel, Hebelstrasse 4, Basel, CH-4031, Switzerland.
¹⁷ Department of Neurosurgery, Kantonsspital Winterthur, Brunngasse 30, Winterthur, CH-8400, Switzerland.
¹⁸ Faculty of Biomedical Sciences, Università Della Svizzera Italiana (USI), Via Giuseppe Buffi 13, Lugano, CH-6900, Switzerland.
¹⁹ Department of Neurosurgery, Hospital of Valais, Avenue Grand-Champsec 80, Sion, CH-1951, Switzerland.
²⁰ Department of Neurosurgery, Hirslanden Klinik Zürich, Witellikerstrasse 40, Zurich, CH-8008, Switzerland.
²¹ Department of Neurosurgery, Kantonsspital St. Gallen, Rohrschacherstrasse 95, St. Gallen, CH-9007, Switzerland.
²² Department of Neurosurgery, Kantonsspital Lucerne, Spitalstrasse 16, Lucerne, CH-6000, Switzerland.

PMID: 39425219
PMCID: PMC11488201
DOI: 10.1186/s13063-024-08534-7

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

Tim Jonas Hallenberger et al. Trials. 2024.

. 2024 Oct 18;25(1):692.

doi: 10.1186/s13063-024-08534-7.

Authors

Affiliations

¹ Department of Neurosurgery, University Hospital Basel, Spitalstrasse 21, Basel, CH-4031, Switzerland. tim.hallenberger@usb.ch.
² Faculty of Medicine, University of Basel, Klingelbergstrasse 61, Basel, CH-4056, Switzerland. tim.hallenberger@usb.ch.
³ Faculty of Medicine, University of Basel, Klingelbergstrasse 61, Basel, CH-4056, Switzerland.
⁴ Department of Neurology, University Hospital Basel and University of Basel, Petersgraben 4, Basel, CH-4031, Switzerland.
⁵ Reha Rheinfelden, Salinenstrasse 98, Rheinfelden, CH-4310, Switzerland.
⁶ Division of Statistics, Department of Clinical Research, University Hospital Basel, Spitalstrasse 12, Basel, CH-4031, Switzerland.
⁷ Buxtorf Quality Services, Traubenweg 4, Allschwil, CH-4123, Switzerland.
⁸ Department of Neurosurgery, University Hospital Basel, Spitalstrasse 21, Basel, CH-4031, Switzerland.
⁹ Service of Neurosurgery, Neurocenter of the Southern Switzerland, Regional Hospital of Lugano, Ente Ospedaliero Cantonale (EOC), Via Tesserete 46, Lugano, CH-6900, Switzerland.
¹⁰ Department of Neurosurgery, Kantonsspital Aarau, Tellstrasse 25, Aarau, CH-5001, Switzerland.
¹¹ Department of Neurosurgery, University Hospital Geneva, Rue Gabrielle-Perret-Gentil 4, Geneva, CH-1211, Switzerland.
¹² Department of Neurosurgery, University Hospital Lausanne (CHUV), Rue du Bugnon 46, Lausanne, CH-1011, Switzerland.
¹³ Department of Neurosurgery, University Hospital Bern, Freiburgerstrasse 10, Bern, CH-3010, Switzerland.
¹⁴ Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zürich and University of Zürich, Raemistrasse 100, Zurich, CH-8091, Switzerland.
¹⁵ Neurosurgical Unit, Kantonsspital Graubünden, Loestrasse 170, Chur, CH-7000, Switzerland.
¹⁶ Multiple Sclerosis Centre and Research Center for Clinical Neuroimmunology and Neuroscience (RC2NB), Departments of Biomedicine and Clinical Research, University Hospital Basel and University of Basel, Hebelstrasse 4, Basel, CH-4031, Switzerland.
¹⁷ Department of Neurosurgery, Kantonsspital Winterthur, Brunngasse 30, Winterthur, CH-8400, Switzerland.
¹⁸ Faculty of Biomedical Sciences, Università Della Svizzera Italiana (USI), Via Giuseppe Buffi 13, Lugano, CH-6900, Switzerland.
¹⁹ Department of Neurosurgery, Hospital of Valais, Avenue Grand-Champsec 80, Sion, CH-1951, Switzerland.
²⁰ Department of Neurosurgery, Hirslanden Klinik Zürich, Witellikerstrasse 40, Zurich, CH-8008, Switzerland.
²¹ Department of Neurosurgery, Kantonsspital St. Gallen, Rohrschacherstrasse 95, St. Gallen, CH-9007, Switzerland.
²² Department of Neurosurgery, Kantonsspital Lucerne, Spitalstrasse 16, Lucerne, CH-6000, Switzerland.

PMID: 39425219
PMCID: PMC11488201
DOI: 10.1186/s13063-024-08534-7

Abstract

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.

Keywords: Bayesian design; Endoscopic surgery; Functional outcome; Intracerebral hemorrhage; Minimally invasive surgery; Patient reported outcome measures; Study protocol.

PubMed Disclaimer

Conflict of interest statement

Dr. Tim Hallenberger discloses that he receives a MD PhD scholarship jointly by the SNSF and the Swiss Academy of Medical Sciences (Grant ID 207030). The remaining authors declare no conflict of interest for the present study.

Figures

**Fig. 1**
Depiction of the key aspects of the surgical techniques. A Navigation of a lobar hemorrhage; B OR set-up for the proposed intervention; C double burr hole approach; D hematoma evacuation trough the Vycor trocar; E view inside the Vycor trocar showing residual blood trough the transparent sheath; F evacuated hematoma cavity

**Fig. 2**
Example template of recommended content for the schedule of enrollment, interventions, and assessments. *mRS assessed blinded by telephone

**Fig. 3**
Projected sample size estimations assuming different proportions of favorable outcome in the BMT group

See this image and copyright information in PMC

References

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1. Krishnamurthi RV, Feigin VL, Forouzanfar MH, Mensah GA, Connor M, Bennett DA, et al. Global and regional burden of first-ever ischaemic and haemorrhagic stroke during 1990–2010: findings from the Global Burden of Disease Study 2010. Lancet Glob Health. 2013;1(5):e259–81. - PMC - PubMed
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Early minimally invasive image-guided endoscopic evacuation of intracerebral hemorrhage (EMINENT-ICH): a randomized controlled trial

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Associated data

LinkOut - more resources

Full Text Sources

Medical