SWITCH
Research type
Research Study
Full title
Swiss Trial of Initial Decompressive Craniectomy versus Best Medical Treatment of Spontaneous Supratentorial Intracerebral Hemorrhage: A Randomized Controlled Trial
IRAS ID
203583
Contact name
Andreas Demetriades
Contact email
Sponsor organisation
Inselspital Bern
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
SNCTP 000001153, www.kofam.ch
Duration of Study in the UK
1 years, 8 months, 30 days
Research summary
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.
REC name
Scotland A: Adults with Incapacity only
REC reference
18/SS/0012
Date of REC Opinion
2 Jul 2018
REC opinion
Further Information Favourable Opinion