SWITCH
Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral haemorrhage: a randomised controlled clinical trial
Clinical Question
Does decompressive craniectomy plus best medical treatment improve clinical outcome at 6 months for people with spontaneous severe deep intracerebral haemorrhage compared to best medical treatment alone?
Bottom Line
The SWITCH trial 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, with a trend toward improved outcome but survival remained associated with severe disability in both groups.
Major Points
- The trial was stopped early due to lack of funding, resulting in being underpowered for the primary endpoint.
- In the intention-to-treat analysis, 42 (44%) of 95 participants in the decompressive craniectomy group and 55 (58%) of 95 in the best medical treatment group had an mRS of 5–6 at 180 days (adjusted risk ratio [aRR] 0.77, 95% CI 0.59 to 1.01, p=0.057).
- Ordinal mRS analysis favored surgery (common odds ratio 0.57, 95% CI 0.34 to 0.97).
- Mortality at 180 days was lower with surgery: 17% vs 27%.
- Severe adverse events occurred in 41% (surgery) vs 44% (control).
- Median hospital stay was shorter in the surgical group: 19.5 vs 23.5 days (p=0.018).
- Survival remained associated with severe disability in most cases.
Design
Study Type: Multicentre, randomised, open-label, assessor-blinded trial
Randomization: 1
Blinding: Assessor-blinded for outcome assessment; investigators and core lab staff masked to allocation and outcomes.
Enrollment Period: October 6, 2014, to April 30, 2023
Follow-up Duration: 6 months (primary outcome), up to 12 months total
Centers: 42
Countries: Austria, Belgium, Finland, France, Germany, Netherlands, Spain, Sweden, Switzerland
Sample Size: 201
Analysis: Intention-to-treat; Mantel-Haenszel risk ratios for binary outcomes; proportional odds regression for ordinal outcomes; linear models for continuous data; multiple imputation for sensitivity.
Inclusion Criteria
- Adults (18–75 years)
- Spontaneous severe deep intracerebral haemorrhage (basal ganglia or thalamus, may extend to lobes, ventricles, or subarachnoid space)
- NIHSS ≥10, ICH volume ≥30 mL, and GCS <14
Arms
| Field | Control | Decompressive craniectomy plus best medical treatment |
|---|---|---|
| Intervention | Best medical management per standard protocols | Decompressive craniectomy (≥12 cm diameter) without haematoma evacuation plus best medical treatment; delayed cranioplasty allowed. |
| Duration | 180 days (primary outcome) | 180 days (primary outcome) |
Outcomes
| Outcome | Type | Control | Intervention | HR / OR / RR | P-value |
|---|---|---|---|---|---|
| mRS 5–6 at 180 days in the intention-to-treat population | Primary | 58% | 44% | 0.77 | 0.057 |
| Ordinal mRS at 180 days | Secondary | Median 5 (IQR 4–6) | Median 4 (IQR 4–5) | 0.57 | 0.039 |
| Mortality at 180 days | Secondary | 27% | 17% | 0.61 | 0.065 |
| Length of hospital stay (median days) | Secondary | 23.5 | 19.5 | 0.74 | 0.018 |
| Any serious adverse event | Adverse | 41 (44%) | 42 (41%) | 0.77 | |
| Infections and infestations | Adverse | 11 (12%) | 12 (12%) | 1.00 | |
| Nervous system disorders | Adverse | 17 (18%) | 17 (17%) | 0.85 |
Criticisms
- Underpowered due to early termination after only 201 of planned 300 patients enrolled.
- Assumed large treatment effect may have masked smaller benefits.
- Open-label design, with possible bias from participant awareness.
- Variability in surgical technique and evolving care standards over long enrollment period.
- Limited female representation (~33%) and lack of ethnic data.
- Data from imaging core lab on specific anatomical involvement not provided.
Subgroup Analysis
No treatment effect heterogeneity across prespecified subgroups (age, haematoma size, etc.).
Funding
Swiss National Science Foundation, Swiss Heart Foundation, Inselspital Stiftung, Boehringer Ingelheim
Based on: SWITCH (The Lancet, 2024)
Authors: Jürgen Beck, Christian Fung, Daniel Strbian, ..., Urs Fischer
Citation: Lancet 2024; 403: 2395-404
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