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

Primary Purpose

Cerebral Vasospasm After Subarachnoid Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Combination of TBA and intraarterial application of vasodilators
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Vasospasm After Subarachnoid Hemorrhage focused on measuring cerebral vasospasm, subarachnoid hemorrhage, transluminal balloon angioplasty, intraarterial treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurochirurgische Klinik, Universitätsklinik
  • Department of Neurosurgery, Johann Wolfgang Goethe-UniversityRecruiting
  • Neurochirurgische Klinik der Universität UlmRecruiting
  • Klinik für Neurochirurgie, UniversitätsklinikumRecruiting
  • Klinik für Neurochirurgie, Universitätsklinikum

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

invasive

conventional

Arm Description

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.

After proof of perfusion relevant CVS only conventional treatment should be performed (no intraarterial therapy).

Outcomes

Primary Outcome Measures

New infarcts between baseline and final MRI

Secondary Outcome Measures

Clinical outcome (mRS, Karnofsky)

Full Information

First Posted
July 21, 2011
Last Updated
July 21, 2011
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01400360
Brief Title
Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage
Acronym
IMCVS
Official Title
Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 %.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Vasospasm After Subarachnoid Hemorrhage
Keywords
cerebral vasospasm, subarachnoid hemorrhage, transluminal balloon angioplasty, intraarterial treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
invasive
Arm Type
Active Comparator
Arm Description
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.
Arm Title
conventional
Arm Type
No Intervention
Arm Description
After proof of perfusion relevant CVS only conventional treatment should be performed (no intraarterial therapy).
Intervention Type
Other
Intervention Name(s)
Combination of TBA and intraarterial application of vasodilators
Intervention Description
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.
Primary Outcome Measure Information:
Title
New infarcts between baseline and final MRI
Time Frame
21 + - 7 days
Secondary Outcome Measure Information:
Title
Clinical outcome (mRS, Karnofsky)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hartmut Vatter, M. D.
Phone
069 / 6301
Ext
5939
Email
h.vatter@em.uni-frankfurt.de
First Name & Middle Initial & Last Name or Official Title & Degree
Joachim Berkefeld, M. D.
Phone
069/ 6301
Ext
5462
Email
j.berkefeld@em.uni-frankfurt.de
Facility Information:
Facility Name
Neurochirurgische Klinik, Universitätsklinik
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Department of Neurosurgery, Johann Wolfgang Goethe-University
City
Frankfurt am Main
ZIP/Postal Code
60528
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hartmut Vatter, M. D.
Phone
069/ 6301
Ext
5939
Email
h.vatter@em.uni-frankfurt.de
First Name & Middle Initial & Last Name & Degree
Joachim Berkefeld, M. D.
Phone
069/ 6301
Ext
5462
Email
j.berkefeld@em.uni-frankfurt.de
Facility Name
Neurochirurgische Klinik der Universität Ulm
City
Günzburg
ZIP/Postal Code
89312
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph König, M. D.
Phone
08221
Ext
9600
Email
ralph.koenig@uni-ulm.de
First Name & Middle Initial & Last Name & Degree
Ralph König, M. D.
Facility Name
Klinik für Neurochirurgie, Universitätsklinikum
City
Jena
ZIP/Postal Code
07743
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rolf Kalff, M. D.
Phone
093641
Ext
9323001
Email
rolf.kalff@med.uni-jena.de
First Name & Middle Initial & Last Name & Degree
Steffi Neumann
Phone
03641
Ext
9324765
Email
steffi.neumann@med.uni-jena.de
First Name & Middle Initial & Last Name & Degree
Rolf Kalff, M. D.
Facility Name
Klinik für Neurochirurgie, Universitätsklinikum
City
Mannheim
ZIP/Postal Code
68169
Country
Germany
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Links:
URL
http://www.kgu.de/neurochirurgie
Description
Department of Neurosurgery, Johann Wolfgang Goethe University, Frankfurt am Main

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

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