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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 microdialysis

Glasgow 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

Page last updated: August 23, 2015

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