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

Not Applicable

• Conditions: Cerebral Vasospasm After Subarachnoid Hemorrhage
• Interventions: Other: Combination of TBA and intraarterial application of vasodilators

• Registration Number: NCT01400360
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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 %.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Status Verified: 2011-05
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-21
• Last Update Submitted: 2011-07-21
• Study First Posted: 2011-07-22
• Last Update Posted: 2011-07-22
• Primary Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
invasive	Combination of TBA and intraarterial application of vasodilators	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	Combination of TBA and intraarterial application of vasodilators	After proof of perfusion relevant CVS only conventional treatment should be performed (no intraarterial therapy).

Primary Outcome Measures

Name	Time	Method
New infarcts between baseline and final MRI	21 + - 7 days

Secondary Outcome Measures

Name	Time	Method
Clinical outcome (mRS, Karnofsky)	6 months

Trial Locations

Locations (4)

Neurochirurgische Klinik der Universität Ulm; 🇩🇪 Günzburg, Germany

Neurochirurgische Klinik, Universitätsklinik; 🇩🇪 Düsseldorf, Germany

Klinik für Neurochirurgie, Universitätsklinikum; 🇩🇪 Mannheim, Germany

Department of Neurosurgery, Johann Wolfgang Goethe-University; 🇩🇪 Frankfurt am Main, Germany