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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
  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 Hospitals:

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
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

Contacts
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

Locations
Germany
Neurochirurgische Klinik, Universitätsklinik Active, not recruiting
Düsseldorf, Germany, 40225
Department of Neurosurgery, Johann Wolfgang Goethe-University Recruiting
Frankfurt am Main, Germany, 60528
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   
Neurochirurgische Klinik der Universität Ulm Recruiting
Günzburg, Germany, 89312
Contact: Ralph König, M. D.    08221 ext 9600    ralph.koenig@uni-ulm.de   
Principal Investigator: Ralph König, M. D.         
Klinik für Neurochirurgie, Universitätsklinikum Recruiting
Jena, Germany, 07743
Contact: Rolf Kalff, M. D.    093641 ext 9323001    rolf.kalff@med.uni-jena.de   
Contact: Steffi Neumann    03641 ext 9324765    steffi.neumann@med.uni-jena.de   
Principal Investigator: Rolf Kalff, M. D.         
Klinik für Neurochirurgie, Universitätsklinikum Active, not recruiting
Mannheim, Germany, 68169
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
  More Information

Additional Information:
No publications provided

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 Hospitals:
cerebral vasospasm
subarachnoid hemorrhage
transluminal balloon angioplasty
intraarterial treatment

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

ClinicalTrials.gov processed this record on November 27, 2014