This trial is active, not recruiting.

Condition subarachnoid hemorrhage
Sponsor Ludwig-Maximilians - University of Munich
Start date November 2011
End date December 2013
Trial size 40 participants
Trial identifier NCT01516671, LMU-XX2011


Subarachnoid hemorrhage (SAH) is associated with a high mortality and frequently leads to severe disability in survivors caused by cerebral vasospasm and infarction.

This study aims to elucidate the role of neuroinflammation (endocannabinoids and cortisol levels in cerebrospinal fluid) in the pathophysiology of cerebral vasospasm and the value of the bilateral bispectral index (BIS) for the early diagnosis of cerebral vasospasm.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Concentrations of endocannabinoids and corticoids in cerebrospinal fluid and blood.
time frame: Once per day from day 1 until day 14 after hospital admission
Bilateral Bispectral Index
time frame: Every second from 0:01 am until 23:59 pm on hospital day 1,2,3,4,5,6,7,8,9,10,11,12,13,14

Secondary Outcomes

Transcranial Doppler
time frame: Every day at 8 am from day 1 until day 14 after hospital admission

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Admission to neurosurgical ICU Klinikum der Universität München - SAH - External CSF drainage Exclusion Criteria: - AGE < 18

Additional Information

Official title Pilot Study on the Role of Neuroinflammation in the Pathophysiology of Subarachnoid Hemorrhage and the Value of the Bilateral Bispectral Index for Early Diagnosis of Cerebral Ischemia After Subarachnoid Hemorrhage.
Principal investigator Volker Huge, MD
Description Subarachnoid hemorrhage (SAH) or bleeding in the brain is a form of stroke. SAH mostly results from ruptured aneurysms. This severe disease often results in death or severe physical or cognitive disabilities and reduced quality of life. One frequent complication after SAH is cerebral vasospasm, a spasm of the big arteries accompanied by infarction of healthy brain tissue. The pathophysiologic processes which drive vasospasm remain unclear. This study aims to examine the role of endocannabinoids and cortisol in cerebrospinal fluid during the development of cerebral vasospasm. Additionally, this study examines whether side difference in the processed electroencephalogram (bilateral bispectral index) may be useful for early detection of cerebral vasospasm.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich.