The effect of Papaverine Hydrochloride on the metabolism and oxygenation of the brain, in patients suffering severe cramps of the cerebral vessels due to severe bleeding from an aneurysm
Phase 1
- Conditions
- To demonstrate the influence of intra-arterial cerebral Papaverine Hydrochloride on cerebral glucose, lactate, pyruvate, glycerol, and glutamate concentrations and cerebral oxygenation in patients suffering severe post-subarachnoid hemorrhage cerebral vasospasmTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-023878-40-AT
- Lead Sponsor
- Medical University Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Patient age > 18 yrs.
Aneurysmal SAH
Saccular and fusiform cerebral aneurysm
Aneurysm treated by surgery or embolisation
Severe post SAH VSP irresponsive to hyperdynamic therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
Intracranial hypertension obviating patient transport
Delayed VSP related strokes on cerebral CT scans
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method