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

July 21, 2011 updated by: Johann Wolfgang Goethe University Hospital
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 %.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Düsseldorf, Germany, 40225
        • Active, not recruiting
        • Neurochirurgische Klinik, Universitätsklinik
      • Frankfurt am Main, Germany, 60528
      • Günzburg, Germany, 89312
        • Recruiting
        • Neurochirurgische Klinik der Universität Ulm
        • Contact:
        • Principal Investigator:
          • Ralph König, M. D.
      • Jena, Germany, 07743
        • Recruiting
        • Klinik für Neurochirurgie, Universitätsklinikum
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rolf Kalff, M. D.
      • Mannheim, Germany, 68169
        • Active, not recruiting
        • Klinik für Neurochirurgie, Universitätsklinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
New infarcts between baseline and final MRI
Time Frame: 21 + - 7 days
21 + - 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical outcome (mRS, Karnofsky)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 21, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JohannWGUH_IMCVS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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