Effects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage
|ClinicalTrials.gov Identifier: NCT01447095|
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : July 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage||Drug: Prostacyclin 1 ng/kg/min Drug: Prostacyclin 2 ng/kg/min Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Prostacyclin Infusion on Cerebral Vessels, Cerebral Bloodflow and Cerebral Metabolism in Patients With Subarachnoid Haemorrhage|
|Study Start Date :||October 2011|
|Primary Completion Date :||June 2014|
|Study Completion Date :||June 2014|
|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||
Continuous i.v. infusion with placebo day 5-10 after SAH
- 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
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447095
|Rigshospitalet, dep. of neurosurgery|
|Copenhagen, Denmark, 2200|
|Principal Investigator:||Rune Rasmussen, MD||Rigshospitalet, Denmark|