If you are getting an aneurysm fixed what is your doctor doing to precondition the brain in case a stroke occurs? ANYTHING AT ALL? Does your doctor even know anything about this?
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Remote ischemic preconditioning in the prevention of ischemic brain damage during intracranial aneurysm treatment (RIPAT): study protocol for a randomized controlled trial
1
Department of Neurosurgery, Medical University of Innsbruck, 35,
Anichstrasse, Innsbruck 6020, Austria
2 Department of Anesthesiology and Intensive Care Medicine, Medical University of Innsbruck, Innsbruck 6020, Austria
3 Central Institute for Medical and Chemical Laboratory Diagnostics, Medical University of Innsbruck, Innsbruck 6020, Austria
4 Department of Neuroradiology, Medical University of Innsbruck, Innsbruck 6020, Austria
5 Department of Neurology, Medical University of Innsbruck, Innsbruck 6020, Austria
6 Department of Public Health and Health Technology Assessment, UMIT Health and Life Sciences University, Hall in Tirol, Austria
2 Department of Anesthesiology and Intensive Care Medicine, Medical University of Innsbruck, Innsbruck 6020, Austria
3 Central Institute for Medical and Chemical Laboratory Diagnostics, Medical University of Innsbruck, Innsbruck 6020, Austria
4 Department of Neuroradiology, Medical University of Innsbruck, Innsbruck 6020, Austria
5 Department of Neurology, Medical University of Innsbruck, Innsbruck 6020, Austria
6 Department of Public Health and Health Technology Assessment, UMIT Health and Life Sciences University, Hall in Tirol, Austria
Trials 2015, 16:594
doi:10.1186/s13063-015-1102-6
The electronic version of this article is the complete one and can be found online at: http://www.trialsjournal.com/content/16/1/594
The electronic version of this article is the complete one and can be found online at: http://www.trialsjournal.com/content/16/1/594
| Received: | 8 March 2015 |
| Accepted: | 3 December 2015 |
| Published: | 29 December 2015 |
© 2015 Tülü et al.
Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Abstract
Background
The treatment of intracranial aneurysms may be associated with cerebral ischemia.
We hypothesize that pre-interventional remote ischemic preconditioning (RIPC) reduces
ischemic cerebral tissue damage in patients undergoing elective intracranial aneurysm
treatment.
Methods/Design
This study is a single-center, prospective, randomized, double-blind explorative trial.
Patients with an unruptured intracranial aneurysm admitted to Innsbruck Medical University
Hospital for coiling or clipping will be consecutively randomized to either the intervention
group (= RIPC by inflating an upper extremity blood-pressure cuff for 3 x 5 min to
200 mmHg) or the control group after induction of anesthesia. Participants will be
randomized 1:1 to either the preconditioning group or the sham group using a random
allocation sequence and block randomization. The precalculated sample size is n = 24 per group. The primary endpoint is the area-under-the-curve concentration of
serum biomarkers (S100B, NSE, GFAP, MMP9, MBP, and cellular microparticles) in the
first five days after treatment. Secondary endpoints are the number and volume of
new ischemic lesions in magnetic resonance imaging and clinical outcome evaluated
with the National Institutes of Health Stroke Scale, the modified Rankin Scale, and
neuropsychological tests at six and twelve months. All outcome variables will be determined
by observers blinded to group allocation. This study was approved by the local institutional
Ethics Committee (UN5164), version 3.0 of the study protocol, dated 20 October 2013.
Discussion
This study uses the elective treatment of intracranial aneurysms as a paradigmatic
situation to explore the neuroprotective effects of RIPC. If effects are demonstrable
in this pilot trial, a larger, prospective phase III trial will be considered.
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