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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier:
NCT01400360
First received: July 21, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose
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 %.

Condition Intervention
Cerebral Vasospasm After Subarachnoid Hemorrhage
Other: Combination of TBA and intraarterial application of vasodilators

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospital:

Primary Outcome Measures:
  • New infarcts between baseline and final MRI [ Time Frame: 21 + - 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical outcome (mRS, Karnofsky) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 92
Study Start Date: August 2009
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: conventional
After proof of perfusion relevant CVS only conventional treatment should be performed (no intraarterial therapy).
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400360

Locations
Germany
Neurochirurgische Klinik, Universitätsklinik
Düsseldorf, Germany, 40225
Department of Neurosurgery, Johann Wolfgang Goethe-University
Frankfurt am Main, Germany, 60528
Neurochirurgische Klinik der Universität Ulm
Günzburg, Germany, 89312
Klinik für Neurochirurgie, Universitätsklinikum
Jena, Germany, 07743
Klinik für Neurochirurgie, Universitätsklinikum
Mannheim, Germany, 68169
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
  More Information

Additional Information:
Responsible Party: Hartmut Vatter, M.D., Dept. of Neurosurgery, Goethe-University Frankfurt
ClinicalTrials.gov Identifier: NCT01400360     History of Changes
Other Study ID Numbers: JohannWGUH_IMCVS 
Study First Received: July 21, 2011
Last Updated: July 21, 2011
Health Authority: Regierungspräsidium Darmstadt: Germany

Keywords provided by Johann Wolfgang Goethe University Hospital:
cerebral vasospasm
subarachnoid hemorrhage
transluminal balloon angioplasty
intraarterial treatment

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Vasodilator Agents

ClinicalTrials.gov processed this record on December 02, 2016