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

Johann Wolfgang Goethe University Hospital

Status: Unknown

Conditions: Cerebral Vasospasm After Subarachnoid Hemorrhage

Treatments: Other: Combination of TBA and intraarterial application of vasodilators

Study type: Interventional

Funder types: Other

Identifiers

NCT01400360

JohannWGUH_IMCVS

Details and patient eligibility

About

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 %.

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

invasive

Active Comparator group

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.

Treatment:

Other: Combination of TBA and intraarterial application of vasodilators

conventional

No Intervention group

Description:

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

Treatment:

Other: Combination of TBA and intraarterial application of vasodilators