Open Access

Jürgen Beck, Christian Fung, Daniel Strbian, Lukas Bütikofer, Werner J. Z'Graggen, Matthias F. Lang, Seraina Beyeler, Jan Gralla, Florian Ringel, Karl Schaller, Nikolaus Plesnila, Marcel Arnold, Werner Hacke, Peter Jüni, Alexander David Mendelow, Christian Stapf, Rustam Al-Shahi Salman, Jenny Bressan, Stefanie Lerch, Arsany Hakim, Nicolas Martinez-Majander, Anna Piippo-Karjalainen, Peter Vajkoczy, Stefan Wolf, Gerrit A. Schubert, Anke Höllig, Michael Veldeman, Roland Roelz, Andreas Gruber, Philip Rauch, Dorothee Mielke, Veit Rohde, Thomas Kerz, Eberhard Uhl, Enea Thanasi, Hagen B. Huttner, Bernd Kallmünzer, L. Jaap Kappelle, Wolfgang Deinsberger, Christian Roth, Robin Lemmens, Jan Leppert, Jose L. Sanmillan, Jonathan M. Coutinho, Katharina A. M. Hackenberg, Gernot Reimann, Mikael Mazighi, Claudio L. A. Bassetti, Heinrich P Mattle, Andreas Raabe, Urs Fischer, Lukas Andereggen, Kerim Beseoglu, Carlo Cereda, Daniel Coluccia, Philippe Desfontaines, Maria Alonso de Leciñana, Christian Freyschlag, Thomas Gaberel, Rüdiger Gerlach, Florian Gessler, Erdem Güresir, Fernando Muñoz, Ramazan Jabbarli, Jens Minnerup, Francisco Moniche, Andre Peeters, Waltraud Pfeilschifter, Turgut Tatlisumak, Judith Weiland, Johannes Woitzik, Maria Wostrack, W. P. Vandertop

• 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 isBackground 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.…