Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage
IMCVS
1 other identifier
interventional
92
1 country
5
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 %.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedJuly 22, 2011
May 1, 2011
2 years
July 21, 2011
July 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
New infarcts between baseline and final MRI
21 + - 7 days
Secondary Outcomes (1)
Clinical outcome (mRS, Karnofsky)
6 months
Study Arms (2)
invasive
ACTIVE COMPARATORAfter 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 INTERVENTIONAfter proof of perfusion relevant CVS only conventional treatment should be performed (no intraarterial therapy).
Interventions
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.
Eligibility Criteria
You may qualify if:
- SAH (WFNS 1-4)
- Perfusion relevant CVS
- Ability for MRI, DSA and intraarterial treatment
You may not qualify if:
- extended cerebral infarcts
- SAH or ICH from AVM or flow associated aneurysm
- Non aneurismal SAH
- Relevant non spastic stenosis of brain supplying arteries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Neurochirurgische Klinik, Universitätsklinik
Düsseldorf, 40225, Germany
Department of Neurosurgery, Johann Wolfgang Goethe-University
Frankfurt am Main, 60528, Germany
Neurochirurgische Klinik der Universität Ulm
Günzburg, 89312, Germany
Klinik für Neurochirurgie, Universitätsklinikum
Jena, 07743, Germany
Klinik für Neurochirurgie, Universitätsklinikum
Mannheim, 68169, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 21, 2011
First Posted
July 22, 2011
Study Start
August 1, 2009
Primary Completion
August 1, 2011
Last Updated
July 22, 2011
Record last verified: 2011-05