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

Study Overview
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Brief Summary
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The purpose of this study is to determine whether prostacyclin is effective in prevention of cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH).

Official Title
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Effect of Prostacyclin Infusion on Cerebral Vessels, Cerebral Bloodflow and Cerebral Metabolism in Patients With Subarachnoid Haemorrhage

Conditions
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Subarachnoid Hemorrhage

Intervention / Treatment
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* Drug: Prostacyclin 1 ng/kg/min
* Drug: Prostacyclin 2 ng/kg/min
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose prostacyclin<br> | Drug: Prostacyclin 1 ng/kg/min<br>* Continuous i.v. infusion of epoprostenol 1 ng/kg/min day 5-10 after SAH<br>* Other names: Flolan;|
| Active Comparator: High dose prostacyclin<br> | Drug: Prostacyclin 2 ng/kg/min<br>* Continuous i.v. infusion of epoprostenol 2 ng/kg/min day 5-10 after SAH<br>* Other names: Flolan;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Continuous i.v. infusion with placebo day 5-10 after SAH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 8 (+/- 1 day) after aneurysm treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral metabolism measured by microdialysis | Cerebral metabolism measured by microdialysis. Lactate, pyruvate, glucose, glutamate and glycerol are measured. | every 2. hour day 3-10 after aneurysm treatment | 
| Glasgow outcome scale (GOS) at 3 months | Glasgow outcome scale (GOS) at 3 months obtained by telephone interview. | 3 months efter SAH | 
| Clinical vasospasm | Clinical vasospasm defined as delayed neurological deficits (DIND). | day 5-10 after SAH | 
| Brain tissue oxygen (PtiO2) | Brain tissue oxygen (PtiO2) measured by Licox catheter. | continuous measurement day 3-10 after SAH | 
| Mean arterial pressure (MAP) | Mean arterial pressure (MAP) measured by arterial catheter. | Continuous day 1-10 after SAH | 
| Radiographic vasospasm measured by CT angiography | Qualitative assessment (none, mild/moderate, severe) of vasospasm. | Measured day 8 +/- 1 day | 
| Level of brain damage biomarker | Serum levels of S100b in peripheral blood | daily day 4-11 after SAH | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subarachnoid hemorrhage, vasospasm, prostacyclin