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.

Fischer, Urs; Fung, Christian; Beyeler, Seraina; Bütikofer, Lukas; Z'Graggen, Werner; Ringel, Florian; Gralla, Jan; Schaller, Karl; Plesnila, Nikolaus; Strbian, Daniel; Arnold, Marcel; Hacke, Werner; Jüni, Peter; Mendelow, Alexander David; Stapf, Christian; Al-Shahi Salman, Rustam; Bressan, Jenny; Lerch, Stefanie; Bassetti, Claudio L. A.; Mattle, Heinrich P; ... (2024). 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. European stroke journal, 9(3), pp. 781-788. Sage 10.1177/23969873241231047

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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 Type:

 Journal Article (Original Article)

Division/Institute:

 04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology
04 Faculty of Medicine > Pre-clinic Human Medicine > Department of Clinical Research (DCR)
04 Faculty of Medicine > Department of Radiology, Neuroradiology and Nuclear Medicine (DRNN) > Institute of Diagnostic and Interventional Neuroradiology
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurosurgery

UniBE Contributor:

 Fischer, Urs Martin, Beyeler, Seraina Martina, Bütikofer, Lukas (B), Z'Graggen, Werner Josef, Gralla, Jan, Arnold, Marcel, Bressan, Jenny Fabienne, Bassetti, Claudio L.A., Mattle, Heinrich, Raabe, Andreas, Beck, Jürgen

Subjects:

 600 Technology > 610 Medicine & health

ISSN:

 2396-9873

Publisher:

 Sage

Language:

 English

Submitter:

 Pubmed Import

Date Deposited:

 13 Feb 2024 15:57

Last Modified:

 23 Aug 2024 00:12

Publisher DOI:

 10.1177/23969873241231047

PubMed ID:

 38347736

Uncontrolled Keywords:

 Intracerebral haemorrhage decompressive craniectomy randomised-controlled trial

BORIS DOI:

 10.48350/192870

URI:

 https://boris.unibe.ch/id/eprint/192870

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