Effects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage
Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Subarachnoid Hemorrhage
Intervention: Prostacyclin 1 ng/kg/min (Drug); Prostacyclin 2 ng/kg/min (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Rune Rasmussen Official(s) and/or principal investigator(s): Rune Rasmussen, MD, Principal Investigator, Affiliation: Rigshospitalet, Denmark
Summary
The purpose of this study is to determine whether prostacyclin is effective in prevention of
cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH).
Clinical Details
Official title: Effect of Prostacyclin Infusion on Cerebral Vessels, Cerebral Bloodflow and Cerebral Metabolism in Patients With Subarachnoid Haemorrhage
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Radiographic vasospasm measured by CT perfusion
Secondary outcome: Cerebral metabolism measured by microdialysisGlasgow outcome scale (GOS) at 3 months Clinical vasospasm Brain tissue oxygen (PtiO2) Mean arterial pressure (MAP) Radiographic vasospasm measured by CT angiography Level of brain damage biomarker
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- SAH verified by CT
- Aneurysm identified and treated
- Fisher grade 3 + 4
- WFNS grade 1-4 (World Federation of Neurosurgical Societies )
Exclusion Criteria:
- Pregnancy/lactation
- Heard failure
- Kidney failure
- Liver failure
- Hemorrhagic diathesis
Locations and Contacts
Rigshospitalet, dep. of neurosurgery, Copenhagen 2200, Denmark
Additional Information
Starting date: October 2011
Last updated: July 18, 2014
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