title: The effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: study protocol for a randomised controlled trial.
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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01447095.
authors: Department of Neurosurgery, Copenhagen University Hospital, 9 Blegdamsvej, Copenhagen, Denmark. rune333@gmail.com
authors: Rune
authors: R
authors: Rasmussen
authors: Jørn
authors: J
authors: Wetterslev
authors: Trine
authors: T
authors: Stavngaard
authors: Jane
authors: J
authors: Skjøth-Rasmussen
authors: Per Olof
authors: PO
authors: Grände
authors: Niels Vidiendal
authors: NV
authors: Olsen
authors: Bertil
authors: B
authors: Romner
mesh_terms: D002533:Cerebral Angiography / Q000379:methods; D002536:Cerebral Arteries / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000503:physiopathology; D002560:Cerebrovascular Circulation / Q000187:drug effects*; D003718:Denmark; D011464:Epoprostenol / Q000008:administration & dosage*; D015600:Glasgow Coma Scale; D006801:Humans; D007263:Infusions, Parenteral; D017551:Microdialysis; D055420:Perfusion Imaging / Q000379:methods; D010865:Pilot Projects; D012039:Regional Blood Flow / Q000187:drug effects; D012107:Research Design; D013345:Subarachnoid Hemorrhage / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014661:Vasoconstriction / Q000187:drug effects*; D014665:Vasodilator Agents / Q000008:administration & dosage*; D020301:Vasospasm, Intracranial / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology
chemical_list: D014665:Vasodilator Agents; D011464:Epoprostenol