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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

Authors

  • C. S. Gathier,

    Corresponding author
    1. Department of Intensive Care, University Medical Centre Utrecht, Utrecht, The Netherlands
    • Correspondence: Celine Gathier, UMC Utrecht Stroke Center, Rudolf Magnus Institute of Neurosciences, Department of Neurosurgery and Neurology, Department of Intensive Care, Room F.06·134, University Medical Centre Utrecht, PO Box 85500, 3508 GA, Utrecht, The Netherlands.

      E-mail: c.s.gathier-2@umcutrecht.nl

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  • W. M. van den Bergh,

    1. Department of Intensive Care, University Medical Centre Groningen, Groningen, The Netherlands
    2. Department of Intensive Care, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands
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  • A. J. C. Slooter,

    1. Department of Intensive Care, University Medical Centre Utrecht, Utrecht, The Netherlands
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  • and for the HIMALAIA-Study Group

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    • Ale Algra, Walter M. van den Bergh, Gus N. Beute, Bert A. Coert, Jan-Willem Dankbaar, Diederik Dippel, Clemens M.F. Dirven, Celine S. Gathier, Janneke Horn, Mathieu van der Jagt, Jozef Kesecioglu, Fop van Kooten, Aad van der Lugt, Marcella C.A. Muller, Annemarie W. Oldenbeuving, Bram van der Pol, Luca Regli, Gabriel J.E Rinkel, Gerwin Roks, Irene C. van der Schaaf, Arjen J.C. Slooter, W. Peter Vandertop, and Bon H. Verweij.

  • Conflict of interest: Celine S. Gathier: no conflicts of interest. Walter M. van den Bergh: no conflicts of interest. Arjen J.C. Slooter: received a grant from the Dutch Heart Foundation (grant 2009B046) and the Netherlands Brain Foundation (grant 2009(1)-72) for this project.
  • Funding: HIMALAIA is a nonprofit study and was funded by de Dutch Heart Foundation (grant 2009B046), and the Netherlands Brain Foundation (grant 2009 (1-72)).

Abstract

Rationale

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.

Aims

To investigate whether induced hypertension improves the functional outcome in patients with delayed cerebral ischemia after SAH.

Design

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.

Study outcomes

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.

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