Cerebral Vasospasm After Subarachnoid Hemorrhage
Conditions
Keywords
cerebral vasospasm, subarachnoid hemorrhage, transluminal balloon angioplasty, intraarterial treatment
Brief summary
Cerebral vasospasm(CVS) after subarachnoid hemorrhage (SAH) results in a considerable amount of transient or even permanent neurological deficits and poor outcome of the patients. Transluminal Balloon angioplasty (TBA) or intraarterial application of vasodilators represents a rescue therapy for severe CVS. Indication, duration and efficacy of this treatment, however, is still under debate. Aim of the study is to investigate if such a rescue treatment can significantly reduce new delayed ischemic cerebral deficits after SAH. Hypothesis is that the occurance of delayed infarcts can be reduced by repetetive intraarterial therapy to more than 50 %.
Interventions
OTHERCombination of TBA and intraarterial application of vasodilators
In the invasive arm CVS should be treated by intraarterial therapy and efficacy controlled by CT or MRI after 48 hours and if necessary repeated.
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* SAH (WFNS 1-4) * Perfusion relevant CVS * Ability for MRI, DSA and intraarterial treatment
Exclusion criteria
* extended cerebral infarcts * SAH or ICH from AVM or flow associated aneurysm * Non aneurismal SAH * Relevant non spastic stenosis of brain supplying arteries
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New infarcts between baseline and final MRI | 21 + - 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcome (mRS, Karnofsky) | 6 months |
Countries
Germany
Contacts
Primary ContactHartmut Vatter, M. D.
Backup ContactJoachim Berkefeld, M. D.
Outcome results
None listed