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

Trials

Bertil Romner⁵  Niels Vidiendal Olsen³  Per Olof Grände⁴  Jane Skjøth-Rasmussen⁵  Trine Stavngaard²  Jørn Wetterslev¹  Rune Rasmussen⁵ 

[1] Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet 9 Blegdamsvej, Copenhagen, Denmark;Department of Radiology, Copenhagen University Hospital, 9 Blegdamsvej, Copenhagen, Denmark;Department of Neuroanesthesiology, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark;Department of Anaesthesia and Intensive Care, Lund University Hospital, 4 Getingevägen, Lund, Sweden;Department of Neurosurgery, Copenhagen University Hospital, 9 Blegdamsvej, Copenhagen, Denmark

关键词: Delayed ischaemic neurological deficit;    Vasospasm;    Epoprostenol;    Prostacyclin;    Subarachnoid haemorrhage;   

Others  :  1095490
DOI  :  10.1186/1745-6215-13-102

 received in 2012-02-09, accepted in 2012-04-19,  发布年份 2012

【 摘 要 】

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.

Trial registration

Clinicaltrials.gov NCT01447095.

【 授权许可】

   
2012 Rasmussen et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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