NCT02258919Completed
Decompressive Hemicraniectomy in Intracerebral Hemorrhage
Swiss Trial of Decompressive Craniectomy Versus Best Medical Treatment of Spontaneous Supratentorial Intracerebral Hemorrhage (SWITCH): a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 14 Nov 2024
Brief summary (registry, in English)
Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30 per 100'000 population, accounting for 2 million (10-15%) of about 15 million strokes worldwide each year. The strategy of decompressive craniectomy (DC) is beneficial in patients with malignant middle cerebral artery (MCA) infarction. Based on the common pathophysiological mechanisms of these two conditions, this procedure is also frequently performed in patients with ICH, but is has not yet been investigated in a randomized trial. The primary objective of this randomized controlled trial is to determine whether decompressive surgery and best medical treatment in patients with spontaneous ICH will improve outcome compared to best medical treatment only. Secondary objectives are to analyze mortality, dependency and quality of life. Safety endpoints are to determine cause of any mortality and the rate of medical and surgical complications after DC compared with best medical treatment alone.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 201 (actual)
- First submitted
- 30 Sept 2014
- Start date
- Oct 2014
- Primary completion date
- 15 Oct 2023
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Stroke
- NCT number
- NCT02258919
What you commit to
- Study type: Interventional
- Participants enrolled: 201
- From Oct 2014 to the primary completion date, 15 Oct 2023
- 32 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ICH due to known or suspected structural abnormality in the brain (e.g., intracranial aneurysm, brain arteriovenous malformation, brain tumor) or brain trauma, or previous stroke thrombolysis
- Concomitant medical illness that would interfere with outcome assessment and follow-up
- Prior major brain surgery within \<6 month or prior DC
- Known definite contraindication for a surgical procedure
- Previous participation in this trial or in another ongoing investigational trial
- Prior symptomatic ICH
Other illness
- Cerebellar or brainstem hemorrhage
- Exclusive lobar hemorrhage
- Known advanced dementia or significant pre-stroke disability
Other
- Randomization not possible within 66 hours after ictus
- Pregnancy
- Foreseeable difficulties in follow-up due to geographic reasons
- A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
- ICH secondary to thrombolysis
- Bilateral areactive pupils
Who the study is looking for
- Written informed consent of the patient or of patient's next of kin plus consent of an independent physician if patient is unable to consent before randomization
- Acute stroke syndrome due to a spontaneous ICH, defined as the sudden occurrence of bleeding into the parenchyma of the basal ganglia and/or thalamus that may extend into the ventricles and into the cerebral lobes, and into the subarachnoid space, confirmed by clinical history and imaging
- Age: ≥18 to ≤75 years
- Glasgow coma scale (GCS) \<14 and \>7
- Neurological deficit with a NIHSS score of ≥10 and ≤30
- Able to be randomly assigned to surgical treatment within 66 hours after ictus
- Surgery performed not later than 6 hours after randomization
- Volume of hematoma ≥30 ml and ≤100 ml
- Stable clot volume
- International normalized ratio (INR) \<1.5, thrombocytes \>100 T/ml
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinik für Neurochirurgie, Kepler Universitätsklinikum Linz Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Dep. of Neurology / Dep. of Neurosurgery, Bern University Hospital Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Dep. of Clinical Neuroscience, Service of Neurosurgery Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Dep. Neurosurgery, Ospedale Regionale di Lugano Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
| Dep. of Neurosurgery, University Hospital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Klinik für Neurochirurgie Uniklinik RWTH Aachen Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| Department of Neurosurgery, Charité - Universitätsmedizin Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Klinik und Poliklinik für Neurochirurgie, Universitätsklinikum Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| Klinik für Neurochirurgie, Universitätsklinikum Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Klinik für Neurochirugie, Helios Klinikum Erfurt Coordinator of this site? Confirm its status | Erfurt | Germany | Unknown status |
| Neurologische Klinik, Universitätsklinikum Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Klinik für Neurochirurgie, Universitätsklinikum Essen (AöR) Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Zentrum der Neurologie und Neurochirurgie, Universitätsklinikum Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Klinik für Neurochirurgie, Universitätsklinikum Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Neurochirurgische Klinik, Universitätsklinikum Gießen und Marburg UKGM Coordinator of this site? Confirm its status | Giessen | Germany | Unknown status |
| Klinik für Neurochirurgie, Universitätsmedizin Göttingen Coordinator of this site? Confirm its status | Göttingen | Germany | Unknown status |
| Klinik für Neurochirurgie, Klinikum Kassel Coordinator of this site? Confirm its status | Kassel | Germany | Unknown status |
| Klinik für Neurochirurgie, Universitätsklinikum Schleswig Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Neurochirurgische Klinik, Universitätsmedizin Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Neurochirurgische Klinik, Universitätsklinikum Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Dep. of Neurosurgery, Klinikum rechts der Isar der Technischen Universität München Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Klinik für Allgemeine Neurologie, Universitätsklinikum Münster Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Klinik für Neurochirurgie, Universitätsklinikum Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Servicio de Neurocirurgía Bellvitge Hospital Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Servicio de Neurología, Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Servicios de Neurología, Neurocirugía y Cuidados Intensivos del Hospital Virgen del Rocío Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Department of Neurology, Helsinki University Central Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| Centre Hospitalier Universitaire de Caen Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Fondation Adolphe de Rothschild Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Academic Medical Center Amsterdam, Department of Neurology Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| University Medical Center Utrecht, Department of Neurology, Department of Neurosurgery Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.