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Swiss study of initial decompressive craniectomy versus best medical treatment of spontaneous supratentorial intracerebral hemorrhage (switch): a randomized controlled trail

English title Swiss study of initial decompressive craniectomy versus best medical treatment of spontaneous supratentorial intracerebral hemorrhage (switch): a randomized controlled trail
Applicant Fischer Urs
Number 150009
Funding scheme Project funding (Div. I-III)
Research institution Universitätsklinik für Neurologie Inselspital Universität Bern
Institution of higher education University of Berne - BE
Main discipline Neurology, Psychiatry
Start/End 01.09.2014 - 31.08.2018
Approved amount 522'354.00
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All Disciplines (2)

Discipline
Neurology, Psychiatry
Surgery

Keywords (6)

Outcome; Randomized controlled trial; Decompressive craniectomy; Neurosurgery; Acute stroke; Intracerebral hemorrhage

Lay Summary (German)

Lead
Die spontane Hirnblutung (intrazerebrale Blutung) ist eine der schwersten Formen eines Hirnschlages und betrifft weltweit über eine Million Menschen pro Jahr. Ungefähr ein Drittel dieser Patienten versterben kurz nach der Blutung und die Mehrzahl der Überlebenden erleiden schwere neurologische Ausfälle mit Langzeitbehinderung. Bisher gibt es abgesehen von der intenisvmedizinischen Betreuung keine Möglichkeiten, wie diesen Patienten geholfen werden kann.
Lay summary

Inhalt und Ziele des Forschungsprojektes

Die neurologischen Ausfälle bei einer Hirnblutung entstehen einerseits durch die Raumforderung der Blutung, andererseits aber auch durch die Hirnschwellung (Hirnödem). Frühere chirurgische Studien versuchten, den Hirnschaden durch eine Entfernung der Blutung (Hämatomevakuation) zu verringern: die chirurgischen Verfahren waren aber leider nicht besser als die beste nicht-chirurgische Therapie. Die dekompressive Kraniektomie ist ein chirurgisches Verfahren, das bei Patienten mit einer Hirnschwellung nach einem schweren ischämischen Hirnschlag (Durchblutungsstörung), nach Hirnverletzungen durch einen Unfall (Trauma) aber auch bei gewissen Hirnentzündungen erfolgreich eingesetzt wird. Dabei wird der Schädelknochen entfernt und der Druck der Hirnblutung auf das angrenzende Hirngewebe reduziert, ohne dass das Gehirn durch eine Ausräumung der Blutung zusätzlich geschädigt wird. Bisher hat allerdings keine randomisierte kontrollierte Studie die Wirksamkeit der dekompressiven Kraniektomie bei Patienten mit einer Hirnblutung  untersucht. In einer retrospektiven Studie konnten wir zeigen, dass dieses Verfahren bei Patienten mit Hirnblutungen sicher und machbar ist und möglicherweise auch die Mortalität senkt im Vergleich zu Patienten, die gemäss bester konservativer Therapie behandelt wurden.  

Mit dieser prospektiven randomisierten Studie möchten wir untersuchten, ob die Hemikraniektomie die Mortalität und den Behinderungsgrad von Patienten mit einer Hirnblutung im Vergleich zur bestmöglichen konservativen Behandlung reduzieren vermag.

Wissenschaftlicher und gesellschaftlicher Kontext des Forschungsprojektes

Ziel dieser Studie ist es, Patienten mit einer Hirnblutung in Zukunft eine Behandlung anbieten zu können, die sowohl die Mortalität wie auch den Behinderungsgrad reduzieren kann.

Direct link to Lay Summary Last update: 20.03.2014

Responsible applicant and co-applicants

Employees

Publications

Publication
Effect of Decompressive Craniectomy on Perihematomal Edema in Patients with Intracerebral Hemorrhage.
Fung Christian, Murek Michael, Klinger-Gratz Pascal P, Fiechter Michael, Z'Graggen Werner J, Gautschi Oliver P, El-Koussy Marwan, Gralla Jan, Schaller Karl, Zbinden Martin, Arnold Marcel, Fischer Urs, Mattle Heinrich P, Raabe Andreas, Beck Jürgen (2016), Effect of Decompressive Craniectomy on Perihematomal Edema in Patients with Intracerebral Hemorrhage., in PloS one, 11(2), 0149169-0149169.

Collaboration

Group / person Country
Types of collaboration
Universitätsmedizin Göttingen, Prof. Dorothee Mielke Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Hospital Universitario Madrid La Paz, Prof. Exuperio Diez Tejedor Spain (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Virgen del Rocio Hospital Sevilla, Dr. med. Javier de la Torre Spain (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
NHS Lothian Western General Hospital Edinburgh, Dr. med. Andreas Demetriades Great Britain and Northern Ireland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Sahlgrenska University Hospital, Prof. Turgut Tatlisukam Sweden (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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HELIOS Klinikum Erfurt, Prof. Rüdiger Gerlach Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Universitätsklinikum Bonn, PD Dr. med. Erdem Güresir Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Universitätsklinikum Würzburg, PD Dr. med. Thomas Westermaier Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Academic Medical Center, University of Amsterdam, Dr. med. Jonathan Coutinho Netherlands (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Klinikum rechts der Isar der Technischen Universität München, PD Dr. med. Maria Wostrack Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Helsinki University Central Hospital, Prof. Daniel Strbian Finland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Universitätsklinikum Mainz, Prof. Florian Ringel Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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Kepler Universitätsklinikum Linz, Prof. Andreas Gruber Austria (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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University Medical Center Utrecht, Prof. Jaap Kappelle Netherlands (Europe)
- in-depth/constructive exchanges on approaches, methods or results
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Universitätsklinikum Münster, Prof. Jens Minnerup Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
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Universitätsklinikum Schleswig-Holstein Campus Luebeck, Dr. med. Jan Leppert Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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Universitätsklinikum Freiburg, PD Dr. med. Christian Fung Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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Hôpitaux Universitaires de Genève, Dr. med. Marco Corniola Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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Universitätsklinikum Frankfurt, Prof. Christian Senft Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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Hospital Santa Creu i Sant Pau Barcelona, Prof. Fernando Muños Hernandez Spain (Europe)
- in-depth/constructive exchanges on approaches, methods or results
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Innsbruck Medical University, Prof. Martin Ortler Austria (Europe)
- in-depth/constructive exchanges on approaches, methods or results
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Universitätsmedizin Charité Berlin, Prof. Peter Vajkoczy Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
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Luzerner Kantonsspital, PD Dr. med. Karl Kothbauer Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
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Ospedale Regionale di Lugano, Dr. med. Pietro Scarone Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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Universitätsklinikum Düsseldorf, PD Dr. med. Kerim Beseoglu Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Centre Hospitalier Universitaire de Caen, Dr. med. Thomas Gaberel France (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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Universitätsklinikum Mannheim, Prof. Daniel Hänggi Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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Universitätsklinikum Erlangen, Prof. Hagen Huttner Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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Hosptial Universitari de Bellvitge Barcelona, Dr. med. Jose Luis Sanmillan Blasco Spain (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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UZ Leuven, Prof. Dr. Robin Lemmens Belgium (Europe)
- in-depth/constructive exchanges on approaches, methods or results
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Universitätsklinikum Aachen, Prof. Gerrit Schubert Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
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Klinikum Kassel, Prof. Wolgang Deinsberger Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
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Universitätsklinikum Essen, PD Dr. med. Ramazan Jabbarli Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Universitätsklinikum Giessen und Marburg UKGM, PD Dr. med. Karsten Schöller Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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UCL St.Luc Bruxelles, Dr. André Peeters Belgium (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
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Fondation Opthalmologique Adolphe de Rothschild Paris, Prof. Mikael Mazighi France (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
Interdisziplinäre Symposium Gefässkrankheiten Individual talk Akutbehandlung der intrazerebralen Blutungen. 28.11.2019 Bern, Switzerland Fischer Urs;
Institute für Anatomie, Universität Bern Individual talk Dekompressive Entlastungskraniektomien. Neurochirurgischer Kraniotomiekurs – welcher Zugang? 22.11.2019 Bern, Switzerland Beck Jürgen;
4th SFCNS Congress Individual talk Treatment of intracerebral haemorrhage: quo vadis. 23.10.2019 Lausanne, Switzerland Fischer Urs;
5th European Stroke Organisation Conference Poster SWISS TRIAL OF INITIAL DECOMPRESSIVE CRANIECTOMY VERSUS BEST MEDICAL TREATMENT OF SPONTANEOUS SUPRATENTORIAL INTRACEREBRAL HEMORRHAGE: A RANDOMIZED TRIAL (SWITCH) 23.05.2019 Milan, Italy Fischer Urs;
Jahrestagung Sektion Vaskuläre Neurochirurgie DGNC Individual talk SWITCH – un update 08.03.2019 Mannheim, Germany Beck Jürgen;
ESO ESMINT ESNR Talk given at a conference Neurosurgery and stroke: where are indications for intervention? 31.01.2019 Bern, Switzerland Beck Jürgen;
Neurovaskukäre Kolloquien Wintersemester 2018/2019 Individual talk SWITCH – pathophysiologische Überlegungen zur Therapie der intrakraniellen Blutung. 18.12.2018 Neurozentrum Universität Freiburg, Germany Beck Jürgen;
Gemeinschaftliches Seminar der Kliniken für Neurologie, Neurochirurgie und Neuropädiatrie sowie den Instituten für Neuroradiologie und Neuropathologie der Universitätsmedizin Essen, Universität Duisburg-Essen Individual talk Intrakranielle Blutungen: Was gibt es Neues? 07.11.2018 Essen, Germany Beck Jürgen;
Berner Stroke Symposium Talk given at a conference Behandlung von intracerebralen Blutungen: wann gibt es endlich Evidenz? 23.08.2018 Bern, Switzerland Fischer Urs;
Investigators Meeting on the occasion of the 69th Congress of the German Society of Neurosurgery Individual talk SWITCH Investigators Meeting 2018 06.06.2018 Münster, Germany Seydoux Emilie; Beck Jürgen;
4th European Stroke Organisation Conference ​(ESOC 2018) Talk given at a conference Is there still a role for surgery in the light of clinical ICH trials? 18.05.2018 Gothenburg, Sweden Fischer Urs;
4th European Stroke Organisation Conference Individual talk Is there still a role for surgery in the light of clinical ICH trials? 18.05.2018 Gothenburg, Sweden Fischer Urs;
4th European Stroke Organisation Conference ​(ESOC 2018) Poster Swiss Trial of Initial Decompressive Craniectomy version Best Medical Treatment of Spontaneous Supratentorial Intracerebral Hemorrhage - A randomized trial (SWITCH) 16.05.2018 Gothenburg , Sweden Fischer Urs; Beck Jürgen; Seydoux Emilie;
Montagsfortbildung; Klinik für Neurochirurgie, Neurozentrum Universität Freiburg Individual talk Chirurgische Behandlung der spontanen intrazerebralen Blutung – SWITCH 07.05.2018 Freiburg, Germany Beck Jürgen;
Dr. Archibald Pitcairne Lecture at the Royal College of Physicians of Edinburgh Individual talk Oral anticoagulation after ischaemic stroke - when is best? 08.02.2018 Edinburgh, Great Britain and Northern Ireland Fischer Urs;
4th European Stroke Science Workshop Talk given at a conference Interventional strategies for ICH: still an option? 16.11.2017 Garmisch Partenkirchen, Germany Beck Jürgen;
Neurochirurgischer Kraniotomiekurs – welcher Zugang? Talk given at a conference Dekompressive Entlastungskraniektomien: supratentoriell, infratentoriell, Chiari 09.11.2017 HUG Genève SFITS, Switzerland Beck Jürgen;
European Association of Neurosurgery Talk given at a conference Neurosurgical treatment of hemorrhagic stroke 03.10.2017 Venice, Italy Raabe Andreas;
ESOC European Stroke Organisation Conference, Session: intracerebral hemorrhage I Talk given at a conference Surgery for ICH – is it still an option? 16.05.2017 Prague, Czech Republic Beck Jürgen;
3rd European Stroke Organisation Conference (ESOC 2017) Poster Swiss Trial of Initial Decompressive Craniectomy version Best Medical Treatment of Spontaneous Supratentorial Intracerebral Hemorrhage - A randomized trial (SWITCH) 16.05.2017 Prague, Czech Republic Beck Jürgen; Burkhardt Lena; Fischer Urs; Bressan Jenny;
Individual conference at the Fondation Rothschild (upon invitation) Individual talk Hemicraniectomy in patients with intracerebral hemorrhage 12.01.2017 Fondation Rothschild, Paris, France Fischer Urs;
Neurochirurgischer Kraniotomiekurs - welcher Zugang? Talk given at a conference Dekompressive Entlastungskraniektomien: supratentoriell, infratentoriell, Chiari 09.12.2016 Bern, Switzerland Beck Jürgen;
Tagung der Arbeitsgruppe Neurovaskuläre Chirurgie der Österreichischen Gesellschaft für Neurochirurgie Talk given at a conference SWITCH Studie – aktueller Stand 11.11.2016 Innsbruck, Austria Beck Jürgen;
Investigators Meeting on the occasion of the 89th Congress of the German Society of Neurology Individual talk SWITCH Investigators Meeting 2016 22.09.2016 Mannheim, Germany Beck Jürgen; Fischer Urs; Bressan Jenny; Bernasconi Corrado Angelo; Burkhardt Lena;
European Association of Neurosurgery Talk given at a conference Management of ICH and Update on SWITCH 07.09.2016 Athens, Greece Raabe Andreas;
British Neurosurgical Research Group Individual talk SWITCH - Decompression for intracerebral hemorrhage 18.03.2016 Cambridge, Great Britain and Northern Ireland Beck Jürgen;
Stroke Winter School Talk given at a conference Neurosurgery and stroke: Where are indications for intervention? 10.02.2016 Bern, Switzerland Beck Jürgen;
Individual conference at the Academic Medical Hospital (upon invitation) Individual talk Hemicraniectomy in patients with intracerebral hemorrhage 05.02.2016 Academic Medical Hospital, Amsterdam, Netherlands Fischer Urs;
Academic Medical Hospital. Amsterdam Individual talk Hemicraniectomy in patients with intracerebral hemorrhage 05.02.2016 Amsterdam, Netherlands Fischer Urs;
19. Jahrestagung der Österreichischen Schlaganfallorganisation Talk given at a conference Die Hemikraniektomie bei intracerebralen Blutungen 23.01.2016 Krems, Austria Fischer Urs;
19. Jahrestagung der Österreichischen Schlaganfallorganisation. Individual talk Die Hemikraniektomie bei intracerebralen Blutungen 23.01.2016 Krems, Austria Fischer Urs;
Neurochirugischer Kraniotomiekurs - welcher Zugang? Talk given at a conference Dekompressive Entlastungskraniektomien: supratentoriell, infratentoriell, Chiari. 14.11.2015 Bern, Switzerland Beck Jürgen;
14. Berner Notfall-Symposium Talk given at a conference Indikation und Interpretation von neuroradiologischer Bildgebung 22.10.2015 Bern, Switzerland Fischer Urs;
SYNS 2nd Neurosurgical Craniotomy Course Talk given at a conference Supratentorial decompressive craniectomy: Which approach? 17.10.2015 Bern, Switzerland Beck Jürgen;
Individual contribution to the Department of Neurosurgery of the Bonn University Individual talk SWITCH – Dekompression bei intrazerebraler Blutung 07.10.2015 Bonn, Germany Beck Jürgen;
Jahrestagung 2015 Schweizerische Gesellschaft für Neurochirurgie Poster Effect of decompressive craniectomy on perihematomal edema in patients with intracerebral hemorrhage 10.09.2015 Luzern, Switzerland Beck Jürgen; Fischer Urs;
EANS Vascular section meeting 2015 Poster Decompressive hemicraniectomy in patients with supratentorial intracerebral hemorrhage: edema development and outcome 08.09.2015 Nice, France Beck Jürgen; Fischer Urs;
Individual contribution - Continuing education Individual talk Strukturierte Morgenfortbildung Universitätsklinik für Neurologie – Blutungen 21.08.2015 Inselspital, Bern, Switzerland Beck Jürgen;
German Society of Neurosurgery 66th Annual Meeting 2015 (DGNC 2015) Poster Decompressive hemicraniectomy in patients with supratentorial intracerebral hemorrhage: edema development and outcome 08.06.2015 Karlsruhe, Germany Beck Jürgen; Fischer Urs;
Arbeitstagung NeuroIntensivMedizin ANIM 2015 Talk given at a conference Dekompressive Hemikraniektomie als Therapieoption raumfordernder intrazerebraler Blutungen 29.01.2015 Berlin, Germany Raabe Andreas;
Interdisziplinärer Fortbildungsnachmittag Gefässkrankheiten Talk given at a conference Intrazerebrale Blutungen 06.12.2014 Inselspital, Bern, Switzerland Beck Jürgen;
Ausbildungskurs für Assistenzärzte in der Weiterbildung zum Facharzt für Neurochirurgie Talk given at a conference Neurochirurgische Zugänge für supra- und infratentorielle Operationen: Indikation, Anatomie, Landmarken, Hands-on Prepanationen 13.11.2014 Bern, Switzerland Beck Jürgen;
1st SYNS Neurosurgical Craniotomy Course Talk given at a conference Supratentorial decompressive craniectomy 31.10.2014 Bern, Switzerland Beck Jürgen;
The XII Thrombolysis Symposium, Thrombolysis, Thrombectomy and Acute Stroke Treatment - TTST 2014 Talk given at a conference Decompression for intracranial bleeds 18.10.2014 Mannheim, Germany Beck Jürgen;
EANS Vascular section meeting 2014 Individual talk Surgical therapy of intracerebral hemorrhage 02.09.2014 Nice, France Raabe Andreas;


Communication with the public

Communication Title Media Place Year
Other activities SWITCH website International 2014

Associated projects

Number Title Start Funding scheme
169975 Safety of Early versus Late initiation of direct oral Anticoagulants in post-ischaemic stroke patients with Non-valvular atrial fibrillation (ELAN safety) 01.09.2017 Project funding (Div. I-III)

Abstract

Summary of the research planBACKGROUND: Non-traumatic intracerebral hemorrhage (ICH) is one of the most serious subtypes of stroke and affects over a million people worldwide each year. About one third of patients with ICH die early after onset and the majority of survivors suffer from major long-term disability. Neurological injury of the ICH is mediated by the mass effect of the hematoma, secondary to brain edema and/or both mechanisms. Treatment of ICH is one of the major unresolved issues of acute stroke treatment. Direct surgical intervention aiming at the removal of the hematoma has failed to improve neurological outcome in randomized controlled trials (RCT) for most subtypes of ICH, especially deep seated hematomas. Decompressive craniectomy (DC), which is beneficial in patients with malignant ischemic infarction of the middle cerebral artery, may indirectly relieve the mass effect, decrease perihematomal tissue pressure, improve blood flow, reduce secondary brain damage and improve outcome without further damage to the brain by surgery. However, no randomized controlled study has ever assessed whether DC in patients with acute ICH improves outcome. We showed in a previous study that DC in patients with supratentorial ICH is feasible and may reduce mortality compared to matched controls with best medical treatment, only. WORKING HYPOTHESIS: The primary null hypothesis to be tested is that there is no effect of DC and best medical treatment compared to best medical treatment alone in patients with acute, spontaneous, supraten-torial ICH.SPECIFIC AIMS/PROJECT: The primary aim of the present trial in patients with acute ICH is to determine the effects of DC on all-cause mortality and dependency at 6 months. Secondary aims of the study are to determine the effects of the treatment on death and dependency separately, as well as on physical function, health-related quality of life (HRQoL), recurrent events, other vascular events, days of hospital stay, and requirement for permanent residential care. EXPERTIMENTAL DESIGN/METHODS: SWITCH is a Swiss national multicenter randomized parallel group trial comparing early DC with best medical treatment, following spontaneous supratentorial ICH. All patients (>18-70 years) with a suspected ICH will be considered for this trial. Main inclusion criteria are a severe neurological deficit (NIHSS =10 and <30; GCS >5 and <15) at randomization and a supratentorial hematoma (volume >15 and <150 ml; >1cm from brain surface). Patients with a hematoma due to a structural abnormality or due to a previous thrombolysis will not be included. Surgery will be performed no later than 72 hours after ictus in patients with stable clot volume. Outcome will be measured at six months by trained investigators blinded to treatment. The primary outcome is death and dependency at 6 months. Favorable outcome is defined as a modified Rankin Scale score of 0 to 4, poor outcome as modified Rankin Scale score of 5 or 6. Given the results from our feasibility study as baseline characteristics a total sample size of 104 patients would be needed to show a signi?cant result (a<0.05) with an 80% certainty (power). A total sample size of 180 (90 patients per group) would suffice to show a signi?cant difference (a =0.0317) between p1=0.3 (unfavourable outcome in treatment group) and p2=0.5 (unfavourable outcome in control group) with a certainty (power) of 85.67%. Therefore, 180 patients will be recruited to the trial over 36 months. Follow-up will take six months with analysis and reporting taking one year. The study will be stopped by the safety committee if there are any concerns (increased mortality, “significant” complications). EXPECTED VALUE OF THE PROPOSED PROJECT: So far, RCTs have failed to show any benefit of surgical and non-surgical treatment approaches in patients with acute ICH. DC could be a new promising treatment option, especially in patients with space-occupying, deep seated supratentorial ICH.
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