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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose prostacyclin | Active Comparator |
| |
| High dose prostacyclin | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostacyclin 1 ng/kg/min | Drug | Continuous i.v. infusion of epoprostenol 1 ng/kg/min day 5-10 after SAH |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropeptide Y | 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. | May 2014 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rune Rasmussen, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, dep. of neurosurgery | Copenhagen | 2200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25414173 | Derived | 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. | |
| 24929796 | Derived |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D011464 | Epoprostenol |
| ID | Term |
|---|---|
| D044062 | Prostaglandins I |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Prostacyclin 2 ng/kg/min | Drug | Continuous i.v. infusion of epoprostenol 2 ng/kg/min day 5-10 after SAH |
|
|
| Placebo | Drug | Continuous i.v. infusion with placebo day 5-10 after SAH |
|
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 |
| 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. |
| 22747768 | Derived | 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. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |