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Lookup NU author(s): Emeritus Professor David Mendelow
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. 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.
Author(s): Beck J, Fung C, Strbian D, Butikofer L, Z'Graggen WJ, Lang MF, Beyeler S, Gralla J, Ringel F, Schaller K, Plesnila N, Arnold M, Hacke W, Juni P, Mendelow AD, Stapf C, Al-Shahi Salman R, Bressan J, Lerch S, Hakim A, Martinez-Majander N, Piippo-Karjalainen A, Vajkoczy P, Wolf S, Schubert GA, Hollig A, Veldeman M, Roelz R, Gruber A, Rauch P, Mielke D, Rohde V, Kerz T, Uhl E, Thanasi E, Huttner HB, Kallmunzer B, Jaap Kappelle L, Deinsberger W, Roth C, Lemmens R, Leppert J, Sanmillan JL, Coutinho JM, Hackenberg KAM, Reimann G, Mazighi M, Bassetti CLA, Mattle HP, Raabe A, Fischer U, Andereggen L, Beseoglu K, Cereda C, Coluccia D, Desfontaines P, Alonso de Lecinana M, Freyschlag C, Gaberel T, Gerlach R, Gessler F, Guresir E, Munoz F, Jabbarli R, Minnerup J, Moniche F, Peeters A, Pfeilschifter W, Tatlisumak T, Weiland J, Woitzik J, Wostrack M, Vandertop WP
Publication type: Article
Publication status: Published
Journal: The Lancet
Year: 2024
Volume: 403
Issue: 10442
Pages: 2395-2404
Print publication date: 01/06/2024
Online publication date: 15/05/2024
Acceptance date: 02/04/2018
Date deposited: 13/06/2024
ISSN (print): 0140-6736
ISSN (electronic): 1474-547X
Publisher: Elsevier BV
URL: https://doi.org/10.1016/S0140-6736(24)00702-5
DOI: 10.1016/S0140-6736(24)00702-5
Data Access Statement: Data from the SWITCH trial are currently not publicly available. The plan is to make them available in the future. A complete de-identified dataset will be made accessible, together with a data dictionary. Requests for access to the data can be made by sending an email together with a research plan to urs.fischer@insel.ch
PubMed id: 38761811
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