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|
|Actual Primary Completion Date :||June 2014|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|