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 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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
European stroke journal - (2024) vom: 12. Feb., Seite 23969873241231047 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Fischer, Urs [VerfasserIn] |
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| Links: |
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| Themen: |
Decompressive craniectomy |
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| Anmerkungen: |
Date Revised 13.02.2024 published: Print-Electronic ClinicalTrials.gov: NCT02258919 Citation Status Publisher |
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| doi: |
10.1177/23969873241231047 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM368378705 |
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| 100 | 1 | |a Fischer, Urs |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Swiss trial of decompressive craniectomy versus best medical treatment of spontaneous supratentorial intracerebral haemorrhage (SWITCH) |b an international, multicentre, randomised-controlled, two-arm, assessor-blinded trial |
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| 500 | |a Date Revised 13.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02258919 | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a DISCUSSION: SWITCH will inform physicians about the outcomes of DC plus BMT in people with spontaneous deep ICH, compared to BMT alone | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02258919 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Intracerebral haemorrhage | |
| 650 | 4 | |a decompressive craniectomy | |
| 650 | 4 | |a randomised-controlled trial | |
| 700 | 1 | |a Fung, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Beyeler, Seraina |e verfasserin |4 aut | |
| 700 | 1 | |a Bütikofer, Lukas |e verfasserin |4 aut | |
| 700 | 1 | |a Z'Graggen, Werner |e verfasserin |4 aut | |
| 700 | 1 | |a Ringel, Florian |e verfasserin |4 aut | |
| 700 | 1 | |a Gralla, Jan |e verfasserin |4 aut | |
| 700 | 1 | |a Schaller, Karl |e verfasserin |4 aut | |
| 700 | 1 | |a Plesnila, Nikolaus |e verfasserin |4 aut | |
| 700 | 1 | |a Strbian, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Arnold, Marcel |e verfasserin |4 aut | |
| 700 | 1 | |a Hacke, Werner |e verfasserin |4 aut | |
| 700 | 1 | |a Jüni, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Mendelow, Alexander David |e verfasserin |4 aut | |
| 700 | 1 | |a Stapf, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Al-Shahi Salman, Rustam |e verfasserin |4 aut | |
| 700 | 1 | |a Bressan, Jenny |e verfasserin |4 aut | |
| 700 | 1 | |a Lerch, Stefanie |e verfasserin |4 aut | |
| 700 | 1 | |a Bassetti, Claudio L A |e verfasserin |4 aut | |
| 700 | 1 | |a Mattle, Heinrich P |e verfasserin |4 aut | |
| 700 | 1 | |a Raabe, Andreas |e verfasserin |4 aut | |
| 700 | 1 | |a Beck, Jürgen |e verfasserin |4 aut | |
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