Randomized Controlled Trial

. 2024 Jun 1;403(10442):2395-2404.

doi: 10.1016/S0140-6736(24)00702-5. Epub 2024 May 15.

Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral haemorrhage: a randomised controlled clinical trial

Jürgen Beck¹, Christian Fung², Daniel Strbian³, Lukas Bütikofer⁴, Werner J Z'Graggen⁵, Matthias F Lang⁶, Seraina Beyeler⁷, Jan Gralla⁶, Florian Ringel⁸, Karl Schaller⁹, Nikolaus Plesnila¹⁰, Marcel Arnold¹¹, Werner Hacke¹², Peter Jüni¹³, Alexander David Mendelow¹⁴, Christian Stapf¹⁵, Rustam Al-Shahi Salman¹⁶, Jenny Bressan¹⁷, Stefanie Lerch¹⁷, Arsany Hakim⁶, Nicolas Martinez-Majander³, Anna Piippo-Karjalainen¹⁸, Peter Vajkoczy¹⁹, Stefan Wolf¹⁹, Gerrit A Schubert²⁰, Anke Höllig²¹, Michael Veldeman²¹, Roland Roelz²², Andreas Gruber²³, Philip Rauch²³, Dorothee Mielke²⁴, Veit Rohde²⁴, Thomas Kerz⁸, Eberhard Uhl²⁵, Enea Thanasi²⁵, Hagen B Huttner²⁶, Bernd Kallmünzer²⁷, L Jaap Kappelle²⁸, Wolfgang Deinsberger²⁹, Christian Roth³⁰, Robin Lemmens³¹, Jan Leppert³², Jose L Sanmillan³³, Jonathan M Coutinho³⁴, Katharina A M Hackenberg³⁵, Gernot Reimann³⁶, Mikael Mazighi³⁷, Claudio L A Bassetti⁷, Heinrich P Mattle⁷, Andreas Raabe¹¹, Urs Fischer³⁸; SWITCH study investigators

Collaborators, Affiliations

Collaborators

Affiliations

¹ Department of Neurosurgery, University of Bern, Bern, Switzerland; Department of Neurosurgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Electronic address: j.beck@uniklinik-freiburg.de.
² Department of Neurosurgery, University of Bern, Bern, Switzerland; Department of Neurosurgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
³ Department of Neurology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
⁴ Department of Clinical Research, University of Bern, Bern, Switzerland.
⁵ Department of Neurosurgery, University of Bern, Bern, Switzerland; Department of Neurology, University of Bern, Bern, Switzerland.
⁶ University Institute of Diagnostic and Interventional Neuroradiology, University of Bern, Bern, Switzerland.
⁷ Department of Neurology, University of Bern, Bern, Switzerland.
⁸ Department of Neurosurgery, University Medical Center Mainz, Mainz, Germany.
⁹ Department of Neurosurgery, University of Geneva, Geneva, Switzerland.
¹⁰ Institute for Stroke and Dementia Research, LMU University Hospital, Munich, Germany.
¹¹ Department of Neurosurgery, University of Bern, Bern, Switzerland.
¹² Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany.
¹³ Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
¹⁴ Department of Neurosurgery, Newcastle General Hospital, Newcastle, UK.
¹⁵ Department of Neurosciences, Université de Montréal, and Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada.
¹⁶ Centre for Clinical Brain Sciences and Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.
¹⁷ Department of Neurology, University of Bern, Bern, Switzerland; Department of Surgery, University Children's Hospital Zurich, Zurich, Switzerland.
¹⁸ Department of Neurosurgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
¹⁹ Department of Neurosurgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.
²⁰ Department of Neurosurgery, RWTH Aachen, University Hospital Aachen, Aachen, Germany; Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland.
²¹ Department of Neurosurgery, RWTH Aachen, University Hospital Aachen, Aachen, Germany.
²² Department of Neurosurgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
²³ Department of Neurosurgery, Kepler University Hospital, Johannes Kepler University, Linz, Austria.
²⁴ Department of Neurosurgery, University Hospital Goettingen, Goettingen, Germany.
²⁵ Department of Neurosurgery, Justus-Liebig-Universität Gießen, Gießen, Germany.
²⁶ Department of Neurology, Justus-Liebig-Universität Gießen, Gießen, Germany; Department of Neurology, Universitätsklinikum Erlangen, Erlangen, Germany.
²⁷ Department of Neurology, Universitätsklinikum Erlangen, Erlangen, Germany.
²⁸ Department of Neurology, Brain Centre Rudolf Magnus, University Medical Centre Utrecht, Utrecht, Netherlands.
²⁹ Department of Neurosurgery, Klinikum Kassel, Kassel, Germany.
³⁰ Department of Neurology, Klinikum Kassel, Kassel, Germany.
³¹ University Hospitals Leuven, Department of Neurology, Leuven, Belgium.
³² Department of Neurosurgery, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
³³ Department of Neurosurgery, Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain.
³⁴ Department of Neurology, Amsterdam University Medical Centers, Location AMC, Amsterdam Neuroscience, University of Amsterdam, Amsterdam, Netherlands.
³⁵ Department of Neurosurgery, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany.
³⁶ Klinikum Dortmund, Klinikum der Universität Witten-Herdecke, Dortmund, Germany.
³⁷ Department of Neurology, Lariboisière University Hospital and Department of Interventional Neuroradiology, Rothschild Foundation Hospital, FHU Neurovasc, INSERM 1144, Paris Cité Université, Paris, France; Department of Neurointensive Care, Rothschild Foundation Hospital, Paris France.
³⁸ Department of Neurology, University of Bern, Bern, Switzerland; Department of Neurology, Basel University Hospital, University of Basel, Basel, Switzerland. Electronic address: urs.fischer@insel.ch.

PMID: 38761811
DOI: 10.1016/S0140-6736(24)00702-5

Free article

Randomized Controlled Trial

Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral haemorrhage: a randomised controlled clinical trial

Jürgen Beck et al. Lancet. 2024.

Free article

. 2024 Jun 1;403(10442):2395-2404.

doi: 10.1016/S0140-6736(24)00702-5. Epub 2024 May 15.

Authors

Collaborators

Affiliations

¹ Department of Neurosurgery, University of Bern, Bern, Switzerland; Department of Neurosurgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Electronic address: j.beck@uniklinik-freiburg.de.
² Department of Neurosurgery, University of Bern, Bern, Switzerland; Department of Neurosurgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
³ Department of Neurology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
⁴ Department of Clinical Research, University of Bern, Bern, Switzerland.
⁵ Department of Neurosurgery, University of Bern, Bern, Switzerland; Department of Neurology, University of Bern, Bern, Switzerland.
⁶ University Institute of Diagnostic and Interventional Neuroradiology, University of Bern, Bern, Switzerland.
⁷ Department of Neurology, University of Bern, Bern, Switzerland.
⁸ Department of Neurosurgery, University Medical Center Mainz, Mainz, Germany.
⁹ Department of Neurosurgery, University of Geneva, Geneva, Switzerland.
¹⁰ Institute for Stroke and Dementia Research, LMU University Hospital, Munich, Germany.
¹¹ Department of Neurosurgery, University of Bern, Bern, Switzerland.
¹² Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany.
¹³ Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
¹⁴ Department of Neurosurgery, Newcastle General Hospital, Newcastle, UK.
¹⁵ Department of Neurosciences, Université de Montréal, and Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada.
¹⁶ Centre for Clinical Brain Sciences and Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.
¹⁷ Department of Neurology, University of Bern, Bern, Switzerland; Department of Surgery, University Children's Hospital Zurich, Zurich, Switzerland.
¹⁸ Department of Neurosurgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
¹⁹ Department of Neurosurgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.
²⁰ Department of Neurosurgery, RWTH Aachen, University Hospital Aachen, Aachen, Germany; Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland.
²¹ Department of Neurosurgery, RWTH Aachen, University Hospital Aachen, Aachen, Germany.
²² Department of Neurosurgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
²³ Department of Neurosurgery, Kepler University Hospital, Johannes Kepler University, Linz, Austria.
²⁴ Department of Neurosurgery, University Hospital Goettingen, Goettingen, Germany.
²⁵ Department of Neurosurgery, Justus-Liebig-Universität Gießen, Gießen, Germany.
²⁶ Department of Neurology, Justus-Liebig-Universität Gießen, Gießen, Germany; Department of Neurology, Universitätsklinikum Erlangen, Erlangen, Germany.
²⁷ Department of Neurology, Universitätsklinikum Erlangen, Erlangen, Germany.
²⁸ Department of Neurology, Brain Centre Rudolf Magnus, University Medical Centre Utrecht, Utrecht, Netherlands.
²⁹ Department of Neurosurgery, Klinikum Kassel, Kassel, Germany.
³⁰ Department of Neurology, Klinikum Kassel, Kassel, Germany.
³¹ University Hospitals Leuven, Department of Neurology, Leuven, Belgium.
³² Department of Neurosurgery, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
³³ Department of Neurosurgery, Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain.
³⁴ Department of Neurology, Amsterdam University Medical Centers, Location AMC, Amsterdam Neuroscience, University of Amsterdam, Amsterdam, Netherlands.
³⁵ Department of Neurosurgery, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany.
³⁶ Klinikum Dortmund, Klinikum der Universität Witten-Herdecke, Dortmund, Germany.
³⁷ Department of Neurology, Lariboisière University Hospital and Department of Interventional Neuroradiology, Rothschild Foundation Hospital, FHU Neurovasc, INSERM 1144, Paris Cité Université, Paris, France; Department of Neurointensive Care, Rothschild Foundation Hospital, Paris France.
³⁸ Department of Neurology, University of Bern, Bern, Switzerland; Department of Neurology, Basel University Hospital, University of Basel, Basel, Switzerland. Electronic address: urs.fischer@insel.ch.

PMID: 38761811
DOI: 10.1016/S0140-6736(24)00702-5

Erratum in

Department of Error.
[No authors listed] [No authors listed] Lancet. 2024 Jun 1;403(10442):2380. doi: 10.1016/S0140-6736(24)01089-4. Lancet. 2024. PMID: 38823994 No abstract available.
Department of Error.
[No authors listed] [No authors listed] Lancet. 2024 Jul 6;404(10447):30. doi: 10.1016/S0140-6736(24)01355-2. Lancet. 2024. PMID: 38971592 No abstract available.

Abstract

Background: It is unknown whether decompressive craniectomy improves clinical outcome for people with spontaneous severe deep intracerebral haemorrhage. The SWITCH trial aimed to assess whether decompressive craniectomy plus best medical treatment in these patients improves outcome at 6 months compared to best medical treatment alone.

Methods: In this multicentre, randomised, open-label, assessor-blinded trial conducted in 42 stroke centres in Austria, Belgium, Finland, France, Germany, the Netherlands, Spain, Sweden, and Switzerland, adults (18-75 years) with a severe intracerebral haemorrhage involving the basal ganglia or thalamus were randomly assigned to receive either decompressive craniectomy plus best medical treatment or best medical treatment alone. The primary outcome was a score of 5-6 on the modified Rankin Scale (mRS) at 180 days, analysed in the intention-to-treat population. This trial is registered with ClincalTrials.gov, NCT02258919, and is completed.

Findings: SWITCH had to be stopped early due to lack of funding. Between Oct 6, 2014, and April 4, 2023, 201 individuals were randomly assigned and 197 gave delayed informed consent (96 decompressive craniectomy plus best medical treatment, 101 best medical treatment). 63 (32%) were women and 134 (68%) men, the median age was 61 years (IQR 51-68), and the median haematoma volume 57 mL (IQR 44-74). 42 (44%) of 95 participants assigned to decompressive craniectomy plus best medical treatment and 55 (58%) assigned to best medical treatment alone had an mRS of 5-6 at 180 days (adjusted risk ratio [aRR] 0·77, 95% CI 0·59 to 1·01, adjusted risk difference [aRD] -13%, 95% CI -26 to 0, p=0·057). In the per-protocol analysis, 36 (47%) of 77 participants in the decompressive craniectomy plus best medical treatment group and 44 (60%) of 73 in the best medical treatment alone group had an mRS of 5-6 (aRR 0·76, 95% CI 0·58 to 1·00, aRD -15%, 95% CI -28 to 0). Severe adverse events occurred in 42 (41%) of 103 participants receiving decompressive craniectomy plus best medical treatment and 41 (44%) of 94 receiving best medical treatment.

Interpretation: SWITCH provides weak evidence that decompressive craniectomy plus best medical treatment might be superior to best medical treatment alone in people with severe deep intracerebral haemorrhage. The results do not apply to intracerebral haemorrhage in other locations, and survival is associated with severe disability in both groups.

Funding: Swiss National Science Foundation, Swiss Heart Foundation, Inselspital Stiftung, and Boehringer Ingelheim.

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Conflict of interest statement

Declaration of interests JBe reports research grants from the Swiss National Science Foundation (SNSF), the Swiss Heart Foundation (SHF), and the German Research Council; co-principal investigator role in the TOSCAN trial and fees for advisory boards and lectures from B Braun, Stryker, and Penumbra; and filed patents (PCT/EP2014/056340; PCT/EP2019/087124). CF reports support from Inselspital Stiftung. DS reports a research grant from governmental educational funding (Finland), hospital research funds (Helsinki University Hospital), and an unrestricted educational grant (Boehringer Ingelheim), with all funds handled by hospital-based institution; partner of the consortium funding for the PROOF trial (EU), LVO check (EU), and an electric impedance tomography project (Jane ja Aatos Erkon Säätiö); consultancies and scientific advisory board for Orion, Herantis Pharma, Boehringer Ingelheim, Portola, Alexion, AstraZeneca, Bristol Myers Squibb, and Janssen; and Data Safety Monitoring Board member role in the ENDOLOW trial. WJZ'G reports support from SNSF, Bangerter Stiftung, Von Tobel Stiftung, Herzstiftung, Baasch Medicus Stiftung, Parkinson Schweiz, Swiss Foundation for Research in Muscle Diseases, and the Stanley Thomas Johnson Foundation. JG reports global principal investigator role in STAR and SWIFT DIRECT trials and a consultancy role for Johnson & Johnson/Cerenovus. FR reports research support from Friedhelm Frees Foundation, state Rhineland Palatine; principal investigator role in PERLA-C study (fees paid to institution); consultancies for Brainlab, Stryker, Cybersurgery, and Spineart (fees paid to FR); speaker fees from Spineart, Stryker, Brainlab, and Ulrich (fees paid to FR); and royalties from Spineart (fees paid to FR). MA reports a scientific advisory board role for and lecture fees from Bayer, Medtronic, Novartis, and Sanofi; a scientific advisory board role for Amgen, Boehringer Ingelheim, BMS, Daiichi Sankyo, Pfizer, and Novo Nordisk; and grants from SNSF and SHF. RA-SS reports research grants from the UK National Institute for Health and Care Research and Chief Scientist Office of the Scottish Government; a consultancy role with Recursion Pharmaceuticals, Bioxodes, and Novo Nordisk (NN9931-4553 and NN9931-4554 endpoint adjudication committee), all paid to the University of Edinburgh, outside the submitted work. AHa reports a grant from SHF. NM-M reports a research grant from the Finnish Medical Foundation. PV reports grants or research support from Deutsche Forschungsgemeinschaft, EU, Einstein Stiftung, EANS, AOSpine, and Berliner Krebs Gesellschaft; honoraria from AOSpine, Brainlab, Spineart, Ulrich Medical, Zeiss, and Icotec; consultancy role with BIT Pharma, Sonovum, and Robeauté; and speaker or teacher fees from DWG, AOSpine, Eurospine, Brain Lab, Aesculap, Medtronic, Zeiss, Icotec, and ESO. RR reports a consultancy role with Ulrich Medical and a research grant from Else-Kröner-Fresenius-Stiftung. HBH received personal honoraria or unrestricted research grants from Portola Pharmaceuticals, Boehringer Ingelheim, Daiichi Sanyko, Bayer AG, Novartis, AstraZeneca, and CSL Behring, outside the submitted work. BK reports a scientific advisory board role with and lecture fees from AstraZeneca and Medtronic, outside the submitted work. RL and JL are senior clinical investigators of FWO Flanders. JC has received research support paid to his institution from Boehringer Ingelheim, Bayer, and AstraZeneca, and is a co-founder and shareholder of TrianecT. MM reports personal fees from Boehringer Ingelheim, AstraZeneca, Novo Nordisk, and Novartis. HPM reports personal fees from Medtronic, Stryker, and Cerenovus. AR reports research grants from Zeiss Meditech and a shareholder role for LEM surgical. UF reports research support from the SNSF and the SHF; a principal investigator role in the ELAN trial and a co-principal investigator role in the DISTAL, TECNO, SWIFT DIRECT, SWITCH, ELAPSE, and ICARUS trials; research grants from Medtronic (BEYOND SWIFT, SWIFT DIRECT), Stryker, Rapid Medical, Penumbra, Medtronic, and Phenox (DISTAL), and Boehringer Ingelheim (TECNO), paid to the institution; consultancies for Medtronic, Stryker, and CSL Behring (fees paid to institution); participation in an advisory board for Alexion/Portola, Boehringer Ingelheim, Biogen, and Acthera (fees paid to institution); a membership role in a clinical event committee of the COATING study (Phenox) and on a data and safety monitoring committee of the TITAN, LATE_MT, and IN EXTREMIS trials; and presidency of the Swiss Neurological Society. All other authors report no competing interests.

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Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral haemorrhage: a randomised controlled clinical trial

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Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral haemorrhage: a randomised controlled clinical trial

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