Back to resultsEffects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage
Primary Purpose
Subarachnoid Hemorrhage
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Prostacyclin 1 ng/kg/min
Prostacyclin 2 ng/kg/min
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Subarachnoid Hemorrhage focused on measuring Subarachnoid hemorrhage, vasospasm, prostacyclin
Eligibility 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
Sites / Locations
- Rigshospitalet, dep. of neurosurgery
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Low dose prostacyclin
High dose prostacyclin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Radiographic vasospasm measured by CT perfusion
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
Cerebral metabolism measured by microdialysis. Lactate, pyruvate, glucose, glutamate and glycerol are measured.
Glasgow outcome scale (GOS) at 3 months
Glasgow outcome scale (GOS) at 3 months obtained by telephone interview.
Clinical vasospasm
Clinical vasospasm defined as delayed neurological deficits (DIND).
Brain tissue oxygen (PtiO2)
Brain tissue oxygen (PtiO2) measured by Licox catheter.
Mean arterial pressure (MAP)
Mean arterial pressure (MAP) measured by arterial catheter.
Radiographic vasospasm measured by CT angiography
Qualitative assessment (none, mild/moderate, severe) of vasospasm.
Level of brain damage biomarker
Serum levels of S100b in peripheral blood
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01447095
Brief Title
Effects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage
Official Title
Effect of Prostacyclin Infusion on Cerebral Vessels, Cerebral Bloodflow and Cerebral Metabolism in Patients With Subarachnoid Haemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rune Rasmussen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether prostacyclin is effective in prevention of cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage
Keywords
Subarachnoid hemorrhage, vasospasm, prostacyclin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose prostacyclin
Arm Type
Active Comparator
Arm Title
High dose prostacyclin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Prostacyclin 1 ng/kg/min
Other Intervention Name(s)
Flolan
Intervention Description
Continuous i.v. infusion of epoprostenol 1 ng/kg/min day 5-10 after SAH
Intervention Type
Drug
Intervention Name(s)
Prostacyclin 2 ng/kg/min
Other Intervention Name(s)
Flolan
Intervention Description
Continuous i.v. infusion of epoprostenol 2 ng/kg/min day 5-10 after SAH
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Continuous i.v. infusion with placebo day 5-10 after SAH
Primary Outcome Measure Information:
Title
Radiographic vasospasm measured by CT perfusion
Description
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
Time Frame
Day 8 (+/- 1 day) after aneurysm treatment
Secondary Outcome Measure Information:
Title
Cerebral metabolism measured by microdialysis
Description
Cerebral metabolism measured by microdialysis. Lactate, pyruvate, glucose, glutamate and glycerol are measured.
Time Frame
every 2. hour day 3-10 after aneurysm treatment
Title
Glasgow outcome scale (GOS) at 3 months
Description
Glasgow outcome scale (GOS) at 3 months obtained by telephone interview.
Time Frame
3 months efter SAH
Title
Clinical vasospasm
Description
Clinical vasospasm defined as delayed neurological deficits (DIND).
Time Frame
day 5-10 after SAH
Title
Brain tissue oxygen (PtiO2)
Description
Brain tissue oxygen (PtiO2) measured by Licox catheter.
Time Frame
continuous measurement day 3-10 after SAH
Title
Mean arterial pressure (MAP)
Description
Mean arterial pressure (MAP) measured by arterial catheter.
Time Frame
Continuous day 1-10 after SAH
Title
Radiographic vasospasm measured by CT angiography
Description
Qualitative assessment (none, mild/moderate, severe) of vasospasm.
Time Frame
Measured day 8 +/- 1 day
Title
Level of brain damage biomarker
Description
Serum levels of S100b in peripheral blood
Time Frame
daily day 4-11 after SAH
Other Pre-specified Outcome Measures:
Title
Neuropeptide Y
Description
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.
Time Frame
May 2014
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rune Rasmussen, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, dep. of neurosurgery
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
25414173
Citation
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.
Results Reference
derived
PubMed Identifier
24929796
Citation
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.
Results Reference
derived
PubMed Identifier
22747768
Citation
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.
Results Reference
derived
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Effects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage
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