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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 %.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| invasive | Active Comparator | 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. |
|
| conventional | No Intervention | After proof of perfusion relevant CVS only conventional treatment should be performed (no intraarterial therapy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of TBA and intraarterial application of vasodilators | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| New infarcts between baseline and final MRI | 21 + - 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome (mRS, Karnofsky) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hartmut Vatter, M. D. | Contact | 069 / 6301 | 5939 | h.vatter@em.uni-frankfurt.de |
| Joachim Berkefeld, M. D. | Contact | 069/ 6301 | 5462 | j.berkefeld@em.uni-frankfurt.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurochirurgische Klinik, Universitätsklinik | Active, not recruiting | Düsseldorf | 40225 | Germany | ||
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| Department of Neurosurgery, Johann Wolfgang Goethe-University |
| Recruiting |
| Frankfurt am Main |
| 60528 |
| Germany |
|
| Neurochirurgische Klinik der Universität Ulm | Recruiting | Günzburg | 89312 | Germany |
|
| Klinik für Neurochirurgie, Universitätsklinikum | Recruiting | Jena | 07743 | Germany |
|
| Klinik für Neurochirurgie, Universitätsklinikum | Active, not recruiting | Mannheim | 68169 | Germany |
| ID | Term |
|---|---|
| D020301 | Vasospasm, Intracranial |
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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