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

Cerebral Vasospasm After Subarachnoid Hemorrhage Clinical Trial

— IMCVS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01400360
• Other study ID #: JohannWGUH_IMCVS
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2011
• Last updated: July 21, 2011
• Start date: August 2009

Study information

• Verified date: May 2011
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: Hartmut Vatter, M. D.
• Phone: 069 / 6301
• Email: h.vatter[@]em.uni-frankfurt.de
• Is FDA regulated: No
• Health authority: Regierungspräsidium Darmstadt: Germany
• Study type: Interventional

Clinical Trial 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 %.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Vasospasm After Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage
• Vasospasm, Intracranial

Intervention

Other:
• Combination 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.

Locations

Country	Name	City	State
Germany	Neurochirurgische Klinik, Universitätsklinik	Düsseldorf
Germany	Department of Neurosurgery, Johann Wolfgang Goethe-University	Frankfurt am Main
Germany	Neurochirurgische Klinik der Universität Ulm	Günzburg
Germany	Klinik für Neurochirurgie, Universitätsklinikum	Jena
Germany	Klinik für Neurochirurgie, Universitätsklinikum	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New infarcts between baseline and final MRI		21 + - 7 days	No
Secondary	Clinical outcome (mRS, Karnofsky)		6 months	No

External Links

•   Department of Neurosurgery, Johann Wolfgang Goethe University, Frankfurt am Main