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Swiss trial of decompressive craniectomy versus best medical treatment of spontaneous supratentorial intracerebral haemorrhage (SWITCH): an international, multicentre, randomised-controlled, two-arm, assessor-blinded trial

Rationale: Decompressive craniectomy (DC) is beneficial in people with malignant middle cerebral artery infarction. Whether DC improves outcome in spontaneous intracerebral haemorrhage (ICH) is unknown. - Aim: To determine whether DC without haematoma evacuation plus best medical treatment (BMT) in...

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Main Authors: Fischer, Urs (Author) , Fung, Christian (Author) , Beyeler, Seraina (Author) , Bütikofer, Lukas (Author) , Z’Graggen, Werner (Author) , Ringel, Florian (Author) , Gralla, Jan (Author) , Schaller, Karl (Author) , Plesnila, Nikolaus (Author) , Strbian, Daniel (Author) , Arnold, Marcel (Author) , Hacke, Werner (Author) , Jüni, Peter (Author) , Mendelow, Alexander David (Author) , Stapf, Christian (Author) , Al-Shahi Salman, Rustam (Author) , Bressan, Jenny (Author) , Lerch, Stefanie (Author) , Bassetti, Claudio L. A. (Author) , Mattle, Heinrich P. (Author) , Raabe, Andreas (Author) , Beck, Jürgen (Author)
Format: Article (Journal)
Language:English
Published: February 12, 2024
In: European stroke journal
Year: 2024, Volume: 9, Issue: 3, Pages: 781-788
ISSN:2396-9881
DOI:10.1177/23969873241231047
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1177/23969873241231047
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Author Notes:Urs Fischer, Christian Fung, Seraina Beyeler, Lukas Bütikofer, Werner Z’Graggen, Florian Ringel, Jan Gralla, Karl Schaller, Nikolaus Plesnila, Daniel Strbian, Marcel Arnold, Werner Hacke, Peter Jüni, Alexander David Mendelow, Christian Stapf, Rustam Al-Shahi Salman, Jenny Bressan, Stefanie Lerch, Claudio L. A. Bassetti, Heinrich P. Mattle, Andreas Raabe, and Jürgen Beck
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Summary:Rationale: Decompressive craniectomy (DC) is beneficial in people with malignant middle cerebral artery infarction. Whether DC improves outcome in spontaneous intracerebral haemorrhage (ICH) is unknown. - Aim: To determine whether DC without haematoma evacuation plus best medical treatment (BMT) in people with ICH decreases the risk of death or dependence at 6 months compared to BMT alone. - Methods and design: SWITCH is an international, multicentre, randomised (1:1), two-arm, open-label, assessor-blinded trial. Key inclusion criteria are age ⩽75 years, stroke due to basal ganglia or thalamic ICH that may extend into cerebral lobes, ventricles or subarachnoid space, Glasgow coma scale of 8-13, NIHSS score of 10-30 and ICH volume of 30-100 mL. Randomisation must be performed <66 h after onset and DC <6 h after randomisation. Both groups will receive BMT. Participants randomised to the treatment group will receive DC of at least 12 cm in diameter according to institutional standards. - Sample size: A sample of 300 participants randomised 1:1 to DC plus BMT versus BMT alone provides over 85% power at a two-sided alpha-level of 0.05 to detect a relative risk reduction of 33% using a chi-squared test. - Outcomes: The primary outcome is the composite of death or dependence, defined as modified Rankin scale score 5-6 at 6 months. Secondary outcomes include death, functional status, quality of life and complications at 180 days and 12 months. - Discussion: SWITCH will inform physicians about the outcomes of DC plus BMT in people with spontaneous deep ICH, compared to BMT alone. - Trial registration: ClinicalTrials.gov Identifier: NCT02258919
Item Description:Gesehen am 23.09.2024
Physical Description:Online Resource
ISSN:2396-9881
DOI:10.1177/23969873241231047

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