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The effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: study protocol for a randomised controlled trial

Rasmussen, Rune; Wetterslev, Jorn; Stavngaard, Trine; Skjoth-Rasmussen, Jane; Grände, Per-Olof LU ; Olsen, Niels Vidiendal and Romner, Bertil (2012) In Trials 13.
Abstract
Background: One of the main causes of mortality and morbidity following subarachnoid haemorrhage (SAH) is the development of cerebral vasospasm, a frequent complication arising in the weeks after the initial bleeding. Despite extensive research, to date no effective treatment of vasospasm exists. Prostacyclin is a potent vasodilator and inhibitor of platelet aggregation. In vitro models have shown a relaxing effect of prostacyclin after induced contraction in cerebral arteries, and a recent pilot trial showed a positive effect on cerebral vasospasm in a clinical setting. No randomised, clinical trials have been conducted, investigating the possible pharmacodynamic effects of prostacyclin on the human brain following SAH. Methods: This... (More)
Background: One of the main causes of mortality and morbidity following subarachnoid haemorrhage (SAH) is the development of cerebral vasospasm, a frequent complication arising in the weeks after the initial bleeding. Despite extensive research, to date no effective treatment of vasospasm exists. Prostacyclin is a potent vasodilator and inhibitor of platelet aggregation. In vitro models have shown a relaxing effect of prostacyclin after induced contraction in cerebral arteries, and a recent pilot trial showed a positive effect on cerebral vasospasm in a clinical setting. No randomised, clinical trials have been conducted, investigating the possible pharmacodynamic effects of prostacyclin on the human brain following SAH. Methods: This trial is a single-centre, randomised, placebo-controlled, parallel group, blinded, clinical, pilot trial. A total of 90 patients with SAH will be randomised to one of three intervention arms: epoprostenol 1 ng/kg/min, epoprostenol 2 ng/kg/min or placebo in addition to standard treatment. Trial medication will start day 5 after SAH and continue to day 10. The primary outcome measure is changes in regional cerebral blood flow from baseline in the arterial territories of the anterior cerebral artery, medial cerebral artery and the posterior cerebral artery, measured by CT perfusion scan. The secondary outcomes will be vasospasm measured by CT angiography, ischaemic parameters measured by brain microdialysis, flow velocities in the medial cerebral artery, clinical parameters and outcome (Glasgow Outcome Scale) at 3 months. (Less)
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author
organization
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type
Contribution to journal
publication status
published
subject
keywords
Subarachnoid haemorrhage, Prostacyclin, Epoprostenol, Vasospasm, Delayed, ischaemic neurological deficit
in
Trials
volume
13
publisher
BioMed Central
external identifiers
  • wos:000310738200002
  • scopus:84863089679
ISSN
1745-6215
DOI
10.1186/1745-6215-13-102
language
English
LU publication?
yes
id
04836a21-f33e-4d90-b136-bdf987882431 (old id 3283212)
date added to LUP
2013-01-07 09:39:47
date last changed
2017-06-04 04:00:12
@article{04836a21-f33e-4d90-b136-bdf987882431,
  abstract     = {Background: One of the main causes of mortality and morbidity following subarachnoid haemorrhage (SAH) is the development of cerebral vasospasm, a frequent complication arising in the weeks after the initial bleeding. Despite extensive research, to date no effective treatment of vasospasm exists. Prostacyclin is a potent vasodilator and inhibitor of platelet aggregation. In vitro models have shown a relaxing effect of prostacyclin after induced contraction in cerebral arteries, and a recent pilot trial showed a positive effect on cerebral vasospasm in a clinical setting. No randomised, clinical trials have been conducted, investigating the possible pharmacodynamic effects of prostacyclin on the human brain following SAH. Methods: This trial is a single-centre, randomised, placebo-controlled, parallel group, blinded, clinical, pilot trial. A total of 90 patients with SAH will be randomised to one of three intervention arms: epoprostenol 1 ng/kg/min, epoprostenol 2 ng/kg/min or placebo in addition to standard treatment. Trial medication will start day 5 after SAH and continue to day 10. The primary outcome measure is changes in regional cerebral blood flow from baseline in the arterial territories of the anterior cerebral artery, medial cerebral artery and the posterior cerebral artery, measured by CT perfusion scan. The secondary outcomes will be vasospasm measured by CT angiography, ischaemic parameters measured by brain microdialysis, flow velocities in the medial cerebral artery, clinical parameters and outcome (Glasgow Outcome Scale) at 3 months.},
  author       = {Rasmussen, Rune and Wetterslev, Jorn and Stavngaard, Trine and Skjoth-Rasmussen, Jane and Grände, Per-Olof and Olsen, Niels Vidiendal and Romner, Bertil},
  issn         = {1745-6215},
  keyword      = {Subarachnoid haemorrhage,Prostacyclin,Epoprostenol,Vasospasm,Delayed,ischaemic neurological deficit},
  language     = {eng},
  publisher    = {BioMed Central},
  series       = {Trials},
  title        = {The effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: study protocol for a randomised controlled trial},
  url          = {http://dx.doi.org/10.1186/1745-6215-13-102},
  volume       = {13},
  year         = {2012},
}