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

NCT ID: NCT01400360

Last Updated: 2011-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Brief Summary

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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 %.

Detailed Description

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Conditions

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Cerebral Vasospasm After Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Combination of TBA and intraarterial application of vasodilators

Intervention Type OTHER

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.

conventional

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

Group Type NO_INTERVENTION

Combination of TBA and intraarterial application of vasodilators

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dept. of Neurosurgery, Goethe-University Frankfurt

Locations

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Neurochirurgische Klinik, Universitätsklinik

Düsseldorf, , Germany

Site Status ACTIVE_NOT_RECRUITING

Department of Neurosurgery, Johann Wolfgang Goethe-University

Frankfurt am Main, , Germany

Site Status RECRUITING

Neurochirurgische Klinik der Universität Ulm

Günzburg, , Germany

Site Status RECRUITING

Klinik für Neurochirurgie, Universitätsklinikum

Jena, , Germany

Site Status RECRUITING

Klinik für Neurochirurgie, Universitätsklinikum

Mannheim, , Germany

Site Status ACTIVE_NOT_RECRUITING

Countries

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Germany

Central Contacts

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Hartmut Vatter, M. D.

Role: CONTACT

069 / 6301 ext. 5939

Joachim Berkefeld, M. D.

Role: CONTACT

069/ 6301 ext. 5462

Facility Contacts

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Hartmut Vatter, M. D.

Role: primary

069/ 6301 ext. 5939

Joachim Berkefeld, M. D.

Role: backup

069/ 6301 ext. 5462

Ralph König, M. D.

Role: primary

08221 ext. 9600

Rolf Kalff, M. D.

Role: primary

093641 ext. 9323001

Steffi Neumann

Role: backup

03641 ext. 9324765

Other Identifiers

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JohannWGUH_IMCVS

Identifier Type: -

Identifier Source: org_study_id

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