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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

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitätsklinik für Neurochirurgie, Kepler Universitätsklinikum Linz
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LinzAustriaUnknown status
UZ Leuven
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LeuvenBelgiumUnknown status
Dep. of Neurology / Dep. of Neurosurgery, Bern University Hospital
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BernSwitzerlandUnknown status
Dep. of Clinical Neuroscience, Service of Neurosurgery
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GenevaSwitzerlandUnknown status
Dep. Neurosurgery, Ospedale Regionale di Lugano
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LuganoSwitzerlandUnknown status
Dep. of Neurosurgery, University Hospital Zürich
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ZurichSwitzerlandUnknown status
Klinik für Neurochirurgie Uniklinik RWTH Aachen
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AachenGermanyUnknown status
Department of Neurosurgery, Charité - Universitätsmedizin Berlin
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BerlinGermanyUnknown status
Klinik und Poliklinik für Neurochirurgie, Universitätsklinikum Bonn
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BonnGermanyUnknown status
Klinik für Neurochirurgie, Universitätsklinikum Düsseldorf
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DüsseldorfGermanyUnknown status
Klinik für Neurochirugie, Helios Klinikum Erfurt
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ErfurtGermanyUnknown status
Neurologische Klinik, Universitätsklinikum Erlangen
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ErlangenGermanyUnknown status
Klinik für Neurochirurgie, Universitätsklinikum Essen (AöR)
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EssenGermanyUnknown status
Zentrum der Neurologie und Neurochirurgie, Universitätsklinikum Frankfurt
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FrankfurtGermanyUnknown status
Klinik für Neurochirurgie, Universitätsklinikum Freiburg
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Freiburg im BreisgauGermanyUnknown status
Neurochirurgische Klinik, Universitätsklinikum Gießen und Marburg UKGM
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GiessenGermanyUnknown status
Klinik für Neurochirurgie, Universitätsmedizin Göttingen
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GöttingenGermanyUnknown status
Klinik für Neurochirurgie, Klinikum Kassel
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KasselGermanyUnknown status
Klinik für Neurochirurgie, Universitätsklinikum Schleswig Holstein
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LübeckGermanyUnknown status
Neurochirurgische Klinik, Universitätsmedizin Mainz
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MainzGermanyUnknown status
Neurochirurgische Klinik, Universitätsklinikum Mannheim
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MannheimGermanyUnknown status
Dep. of Neurosurgery, Klinikum rechts der Isar der Technischen Universität München
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MunichGermanyUnknown status
Klinik für Allgemeine Neurologie, Universitätsklinikum Münster
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MünsterGermanyUnknown status
Klinik für Neurochirurgie, Universitätsklinikum Würzburg
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WürzburgGermanyUnknown status
Servicio de Neurocirurgía Bellvitge Hospital
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BarcelonaSpainUnknown status
Servicio de Neurología, Hospital Universitario La Paz
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MadridSpainUnknown status
Servicios de Neurología, Neurocirugía y Cuidados Intensivos del Hospital Virgen del Rocío
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SevilleSpainUnknown status
Department of Neurology, Helsinki University Central Hospital
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HelsinkiFinlandUnknown status
Centre Hospitalier Universitaire de Caen
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CaenFranceUnknown status
Fondation Adolphe de Rothschild
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ParisFranceUnknown status
Academic Medical Center Amsterdam, Department of Neurology
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AmsterdamNetherlandsUnknown status
University Medical Center Utrecht, Department of Neurology, Department of Neurosurgery
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UtrechtNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.