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
Recruitment status was Recruiting
Sponsor:
Johann Wolfgang Goethe University Hospitals
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
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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
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 Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013