title: HIMALAIA (Hypertension Induction in the Management of AneurysmaL subArachnoid haemorrhage with secondary IschaemiA): a randomized single-blind controlled trial of induced hypertension vs. no induced hypertension in the treatment of delayed cerebral ischemia after subarachnoid hemorrhage.
abstract: BACKGROUND
  Delayed cerebral ischemia (DCI) is a major complication after aneurysmal subarachnoid hemorrhage (SAH). One option to treat delayed cerebral ischemia is to use induced hypertension, but its efficacy on the eventual outcome has not been proven in a randomized clinical trial. This article describes the design of the HIMALAIA trial (Hypertension Induction in the Management of AneurysmaL subArachnoid haemorrhage with secondary IschaemiA), designed to assess the effectiveness of induced hypertension on neurological outcome in patients with DCI after SAH.
  
  
  OBJECTIVE
  To investigate whether induced hypertension improves the functional outcome in patients with delayed cerebral ischemia after SAH.
  
  
  METHODS
  The HIMALAIA trial is a multicenter, singe-blinded, randomized controlled trial in patients with DCI after a recent SAH. Eligible patients will be randomized to either induced hypertension (n = 120) or to no induced hypertension (n = 120). In selected centers, the efficacy of induced hypertension in augmenting cerebral blood flow will be measured by means of cerebral perfusion computerized tomography scanning. Follow-up assessments will be performed at 3 and 12 months after randomization by trial nurses who are blinded to the treatment allocation and management. We will include patients during five years.
  
  
  RESULTS
  The primary outcome is the proportion of subarachnoid hemorrhage patients with delayed cerebral ischemia with poor outcome three-months after randomization, defined as a modified Rankin scale of more than 3. Secondary outcome measures are related to treatment failure, functional outcome, adverse events, and cerebral hemodynamics. The HIMALAIA trial is registered at clinicaltrials.gov under identifier NCT01613235.
authors.affiliation: Department of Intensive Care, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: C S
authors.initials: CS
authors.lastname: Gathier
authors.forename: W M
authors.initials: WM
authors.lastname: van den Bergh
authors.forename: A J C
authors.initials: AJ
authors.lastname: Slooter
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D002545:Brain Ischemia / Q000150:complications*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000209:etiology*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D055420:Perfusion Imaging; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013345:Subarachnoid Hemorrhage / Q000150:complications*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents
keywords: aneurysmal subarachnoid hemorrhage; brain ischemia; delayed cerebral ischemia; hypertension; randomized controlled trial