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

This study is currently recruiting participants.
Verified April 2014 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Rune Rasmussen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01447095
First received: October 2, 2011
Last updated: April 10, 2014
Last verified: April 2014
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Radiographic vasospasm measured by CT perfusion [ Time Frame: Day 8 (+/- 1 day) after aneurysm treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Glasgow outcome scale (GOS) at 3 months obtained by telephone interview.

  • Clinical vasospasm [ Time Frame: day 5-10 after SAH ] [ Designated as safety issue: No ]
    Clinical vasospasm defined as delayed neurological deficits (DIND).

  • Brain tissue oxygen (PtiO2) [ Time Frame: continuous measurement day 3-10 after SAH ] [ Designated as safety issue: No ]
    Brain tissue oxygen (PtiO2) measured by Licox catheter.

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

  • Radiographic vasospasm measured by CT angiography [ Time Frame: Measured day 8 +/- 1 day ] [ Designated as safety issue: No ]
    Qualitative assessment (none, mild/moderate, severe) of vasospasm.

  • Level of brain damage biomarker [ Time Frame: daily day 4-11 after SAH ] [ Designated as safety issue: No ]
    Serum levels of S100b in peripheral blood


Other Outcome Measures:
  • Neuropeptide Y [ Time Frame: May 2014 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 90
Study Start Date: October 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447095

Contacts
Contact: Rune Ramussen, MD +45 20157524 rune333@gmail.com

Locations
Denmark
Rigshospitalet, dep. of neurosurgery Recruiting
Copenhagen, Denmark, 2200
Contact: Rune Rasmussen, MD    +45 20157524    rune333@gmail.com   
Principal Investigator: Rune Rasmussen, MD         
Principal Investigator: Bertil Romner, MD, ph.d.         
Sponsors and Collaborators
Rune Rasmussen
Investigators
Principal Investigator: Rune Rasmussen, MD Rigshospitalet, Denmark
  More Information

No publications provided by Rigshospitalet, Denmark

Additional 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
Study First Received: October 2, 2011
Last Updated: April 10, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by 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
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on April 14, 2014