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

NCT01400360 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2011-07-22

No results posted yet for this study

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 %.

Conditions

  • Cerebral Vasospasm After Subarachnoid Hemorrhage

Interventions

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.

Sponsors & Collaborators

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01400360 on ClinicalTrials.gov