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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01400360
First received: July 21, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted

July 21, 2011
July 21, 2011
August 2009
August 2011   (final data collection date for primary outcome measure)
New infarcts between baseline and final MRI [ Time Frame: 21 + - 7 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Clinical outcome (mRS, Karnofsky) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage
Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage

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 %.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cerebral Vasospasm After Subarachnoid Hemorrhage
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.
  • Active Comparator: invasive
    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.
    Intervention: Other: Combination of TBA and intraarterial application of vasodilators
  • No Intervention: conventional
    After proof of perfusion relevant CVS only conventional treatment should be performed (no intraarterial therapy).
    Intervention: Other: Combination of TBA and intraarterial application of vasodilators
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
92
Not Provided
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Hartmut Vatter, M. D. 069 / 6301 ext 5939 h.vatter@em.uni-frankfurt.de
Contact: Joachim Berkefeld, M. D. 069/ 6301 ext 5462 j.berkefeld@em.uni-frankfurt.de
Germany
 
NCT01400360
JohannWGUH_IMCVS
No
Hartmut Vatter, M.D., Dept. of Neurosurgery, Goethe-University Frankfurt
Johann Wolfgang Goethe University Hospitals
Not Provided
Not Provided
Johann Wolfgang Goethe University Hospitals
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP