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Effects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01447095
First Posted: October 5, 2011
Last Update Posted: July 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rune Rasmussen, Rigshospitalet, Denmark
  Purpose
The purpose of this study is to determine whether prostacyclin is effective in prevention of cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH).

Condition Intervention Phase
Subarachnoid Hemorrhage Drug: Prostacyclin 1 ng/kg/min Drug: Prostacyclin 2 ng/kg/min Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Prostacyclin Infusion on Cerebral Vessels, Cerebral Bloodflow and Cerebral Metabolism in Patients With Subarachnoid Haemorrhage

Resource links provided by NLM:


Further study details as provided by Rune Rasmussen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Radiographic vasospasm measured by CT perfusion [ Time Frame: Day 8 (+/- 1 day) after aneurysm treatment ]
    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


Secondary Outcome Measures:
  • Cerebral metabolism measured by microdialysis [ Time Frame: every 2. hour day 3-10 after aneurysm treatment ]
    Cerebral metabolism measured by microdialysis. Lactate, pyruvate, glucose, glutamate and glycerol are measured.

  • Glasgow outcome scale (GOS) at 3 months [ Time Frame: 3 months efter SAH ]
    Glasgow outcome scale (GOS) at 3 months obtained by telephone interview.

  • Clinical vasospasm [ Time Frame: day 5-10 after SAH ]
    Clinical vasospasm defined as delayed neurological deficits (DIND).

  • Brain tissue oxygen (PtiO2) [ Time Frame: continuous measurement day 3-10 after SAH ]
    Brain tissue oxygen (PtiO2) measured by Licox catheter.

  • Mean arterial pressure (MAP) [ Time Frame: Continuous day 1-10 after SAH ]
    Mean arterial pressure (MAP) measured by arterial catheter.

  • Radiographic vasospasm measured by CT angiography [ Time Frame: Measured day 8 +/- 1 day ]
    Qualitative assessment (none, mild/moderate, severe) of vasospasm.

  • Level of brain damage biomarker [ Time Frame: daily day 4-11 after SAH ]
    Serum levels of S100b in peripheral blood


Other Outcome Measures:
  • Neuropeptide Y [ Time Frame: May 2014 ]
    Neuropeptide Y will be measured in all patients Day 2-11. The concentration will be related to CBF, angiographic vasospasm and clinical outcome for all patients. The results will be reported in a separate puplication.


Enrollment: 90
Study Start Date: October 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low dose prostacyclin Drug: Prostacyclin 1 ng/kg/min
Continuous i.v. infusion of epoprostenol 1 ng/kg/min day 5-10 after SAH
Other Name: Flolan
Active Comparator: High dose prostacyclin Drug: Prostacyclin 2 ng/kg/min
Continuous i.v. infusion of epoprostenol 2 ng/kg/min day 5-10 after SAH
Other Name: Flolan
Placebo Comparator: Placebo Drug: Placebo
Continuous i.v. infusion with placebo day 5-10 after SAH

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447095


Locations
Denmark
Rigshospitalet, dep. of neurosurgery
Copenhagen, Denmark, 2200
Sponsors and Collaborators
Rune Rasmussen
Investigators
Principal Investigator: Rune Rasmussen, MD Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rune Rasmussen, MD, Sponsor-Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01447095     History of Changes
Other Study ID Numbers: 2011-002798-50
First Submitted: October 2, 2011
First Posted: October 5, 2011
Last Update Posted: July 21, 2014
Last Verified: July 2014

Keywords provided by Rune Rasmussen, Rigshospitalet, Denmark:
Subarachnoid hemorrhage
vasospasm
prostacyclin

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Epoprostenol
Tezosentan
Antihypertensive Agents
Platelet Aggregation Inhibitors
Vasodilator Agents