Effects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage
NCT ID: NCT01447095
Last Updated: 2014-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2011-10-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Low dose prostacyclin
Prostacyclin 1 ng/kg/min
Continuous i.v. infusion of epoprostenol 1 ng/kg/min day 5-10 after SAH
High dose prostacyclin
Prostacyclin 2 ng/kg/min
Continuous i.v. infusion of epoprostenol 2 ng/kg/min day 5-10 after SAH
Placebo
Placebo
Continuous i.v. infusion with placebo day 5-10 after SAH
Interventions
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Prostacyclin 1 ng/kg/min
Continuous i.v. infusion of epoprostenol 1 ng/kg/min day 5-10 after SAH
Prostacyclin 2 ng/kg/min
Continuous i.v. infusion of epoprostenol 2 ng/kg/min day 5-10 after SAH
Placebo
Continuous i.v. infusion with placebo day 5-10 after SAH
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aneurysm identified and treated
* Fisher grade 3 + 4
* WFNS grade 1-4 (World Federation of Neurosurgical Societies )
Exclusion Criteria
* Heard failure
* Kidney failure
* Liver failure
* Hemorrhagic diathesis
18 Years
ALL
No
Sponsors
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Rune Rasmussen
OTHER
Responsible Party
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Rune Rasmussen
MD, Sponsor-Investigator
Principal Investigators
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Rune Rasmussen, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet, dep. of neurosurgery
Copenhagen, , Denmark
Countries
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References
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Rasmussen R, Wetterslev J, Stavngaard T, Juhler M, Skjoth-Rasmussen J, Grande PO, Olsen NV. Effects of prostacyclin on cerebral blood flow and vasospasm after subarachnoid hemorrhage: randomized, pilot trial. Stroke. 2015 Jan;46(1):37-41. doi: 10.1161/STROKEAHA.114.007470. Epub 2014 Nov 20.
Rasmussen R, Juhler M, Wetterslev J. Effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: statistical analysis plan for a randomized controlled trial. Trials. 2014 Jun 14;15:228. doi: 10.1186/1745-6215-15-228.
Rasmussen R, Wetterslev J, Stavngaard T, Skjoth-Rasmussen J, Grande PO, Olsen NV, Romner B. The effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: study protocol for a randomised controlled trial. Trials. 2012 Jul 2;13:102. doi: 10.1186/1745-6215-13-102.
Other Identifiers
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2011-002798-50
Identifier Type: -
Identifier Source: org_study_id
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