Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage

Study Overview
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Brief Summary
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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 %.

Official Title
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Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage

Conditions
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Cerebral Vasospasm After Subarachnoid Hemorrhage

Intervention / Treatment
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* Other: Combination of TBA and intraarterial application of vasodilators


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: invasive<br>After proof of perfusion relevant CVS in interventional therapy should be performed as best possible combination from TBA and intraarterial vasodilators additional to the conventional treatment. | Other: Combination of TBA and intraarterial application of vasodilators<br>* 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.<br>|
| No Intervention: conventional<br>After proof of perfusion relevant CVS only conventional treatment should be performed (no intraarterial therapy). | Other: Combination of TBA and intraarterial application of vasodilators<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New infarcts between baseline and final MRI |  | 21 + - 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome (mRS, Karnofsky) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral vasospasm, subarachnoid hemorrhage, transluminal balloon angioplasty, intraarterial treatment