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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.
Beck, Jürgen; Fung, Christian; Strbian, Daniel; Bütikofer, Lukas; Z'Graggen, Werner J; Lang, Matthias F; Beyeler, Seraina; Gralla, Jan; Ringel, Florian; Schaller, Karl; Plesnila, Nikolaus; Arnold, Marcel; Hacke, Werner; Jüni, Peter; Mendelow, Alexander David; Stapf, Christian; Al-Shahi Salman, Rustam; Bressan, Jenny; Lerch, Stefanie; Hakim, Arsany; Martinez-Majander, Nicolas; Piippo-Karjalainen, Anna; Vajkoczy, Peter; Wolf, Stefan; Schubert, Gerrit A; Höllig, Anke; Veldeman, Michael; Roelz, Roland; Gruber, Andreas; Rauch, Philip; Mielke, Dorothee; Rohde, Veit; Kerz, Thomas; Uhl, Eberhard; Thanasi, Enea; Huttner, Hagen B; Kallmünzer, Bernd; Jaap Kappelle, L; Deinsberger, Wolfgang; Roth, Christian; Lemmens, Robin; Leppert, Jan; Sanmillan, Jose L; Coutinho, Jonathan M; Hackenberg, Katharina A M; Reimann, Gernot; Mazighi, Mikael; Bassetti, Claudio L A; Mattle, Heinrich P; Raabe, Andreas.
Affiliation
  • Beck J; 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.
  • Fung C; Department of Neurosurgery, University of Bern, Bern, Switzerland; Department of Neurosurgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
  • Strbian D; Department of Neurology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
  • Bütikofer L; Department of Clinical Research, University of Bern, Bern, Switzerland.
  • Z'Graggen WJ; Department of Neurosurgery, University of Bern, Bern, Switzerland; Department of Neurology, University of Bern, Bern, Switzerland.
  • Lang MF; University Institute of Diagnostic and Interventional Neuroradiology, University of Bern, Bern, Switzerland.
  • Beyeler S; Department of Neurology, University of Bern, Bern, Switzerland.
  • Gralla J; University Institute of Diagnostic and Interventional Neuroradiology, University of Bern, Bern, Switzerland.
  • Ringel F; Department of Neurosurgery, University Medical Center Mainz, Mainz, Germany.
  • Schaller K; Department of Neurosurgery, University of Geneva, Geneva, Switzerland.
  • Plesnila N; Institute for Stroke and Dementia Research, LMU University Hospital, Munich, Germany.
  • Arnold M; Department of Neurosurgery, University of Bern, Bern, Switzerland.
  • Hacke W; Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany.
  • Jüni P; Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
  • Mendelow AD; Department of Neurosurgery, Newcastle General Hospital, Newcastle, UK.
  • Stapf C; Department of Neurosciences, Université de Montréal, and Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada.
  • Al-Shahi Salman R; Centre for Clinical Brain Sciences and Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.
  • Bressan J; Department of Neurology, University of Bern, Bern, Switzerland; Department of Surgery, University Children's Hospital Zurich, Zurich, Switzerland.
  • Lerch S; Department of Neurology, University of Bern, Bern, Switzerland; Department of Surgery, University Children's Hospital Zurich, Zurich, Switzerland.
  • Hakim A; University Institute of Diagnostic and Interventional Neuroradiology, University of Bern, Bern, Switzerland.
  • Martinez-Majander N; Department of Neurology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
  • Piippo-Karjalainen A; Department of Neurosurgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
  • Vajkoczy P; Department of Neurosurgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.
  • Wolf S; Department of Neurosurgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.
  • Schubert GA; Department of Neurosurgery, RWTH Aachen, University Hospital Aachen, Aachen, Germany; Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland.
  • Höllig A; Department of Neurosurgery, RWTH Aachen, University Hospital Aachen, Aachen, Germany.
  • Veldeman M; Department of Neurosurgery, RWTH Aachen, University Hospital Aachen, Aachen, Germany.
  • Roelz R; Department of Neurosurgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
  • Gruber A; Department of Neurosurgery, Kepler University Hospital, Johannes Kepler University, Linz, Austria.
  • Rauch P; Department of Neurosurgery, Kepler University Hospital, Johannes Kepler University, Linz, Austria.
  • Mielke D; Department of Neurosurgery, University Hospital Goettingen, Goettingen, Germany.
  • Rohde V; Department of Neurosurgery, University Hospital Goettingen, Goettingen, Germany.
  • Kerz T; Department of Neurosurgery, University Medical Center Mainz, Mainz, Germany.
  • Uhl E; Department of Neurosurgery, Justus-Liebig-Universität Gießen, Gießen, Germany.
  • Thanasi E; Department of Neurosurgery, Justus-Liebig-Universität Gießen, Gießen, Germany.
  • Huttner HB; Department of Neurology, Justus-Liebig-Universität Gießen, Gießen, Germany; Department of Neurology, Universitätsklinikum Erlangen, Erlangen, Germany.
  • Kallmünzer B; Department of Neurology, Universitätsklinikum Erlangen, Erlangen, Germany.
  • Jaap Kappelle L; Department of Neurology, Brain Centre Rudolf Magnus, University Medical Centre Utrecht, Utrecht, Netherlands.
  • Deinsberger W; Department of Neurosurgery, Klinikum Kassel, Kassel, Germany.
  • Roth C; Department of Neurology, Klinikum Kassel, Kassel, Germany.
  • Lemmens R; University Hospitals Leuven, Department of Neurology, Leuven, Belgium.
  • Leppert J; Department of Neurosurgery, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
  • Sanmillan JL; Department of Neurosurgery, Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain.
  • Coutinho JM; Department of Neurology, Amsterdam University Medical Centers, Location AMC, Amsterdam Neuroscience, University of Amsterdam, Amsterdam, Netherlands.
  • Hackenberg KAM; Department of Neurosurgery, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany.
  • Reimann G; Klinikum Dortmund, Klinikum der Universität Witten-Herdecke, Dortmund, Germany.
  • Mazighi M; 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.
  • Bassetti CLA; Department of Neurology, University of Bern, Bern, Switzerland.
  • Mattle HP; Department of Neurology, University of Bern, Bern, Switzerland.
  • Raabe A; Department of Neurosurgery, University of Bern, Bern, Switzerland.
Lancet ; 403(10442): 2395-2404, 2024 Jun 01.
Article in En | MEDLINE | ID: mdl-38761811
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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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Cerebral Hemorrhage / Decompressive Craniectomy Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: En Journal: Lancet Year: 2024 Type: Article
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Cerebral Hemorrhage / Decompressive Craniectomy Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: En Journal: Lancet Year: 2024 Type: Article