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This is a multi-center, prospective,
partially blinded, longitudinal study of the rate of recovery of neuropsychological
function after sub-arachnoid hemorrhage (SAH). Patients who have undergone
craniotomy for clipping of intra-cranial aneurysms will be studied. Goal
of this investigation is to characterize the effects of intra-operative
hypothermia and anatomical location of aneurysm on the rate of recovery
of neuropsychological function. A secondary goal is to study the relationship
between neurological outcome (as determined by GOS) and neuropsychological
function. Patients in IHAST are randomized to normothermic (36.5°C)
and hypothermic (33°C) groups based on the core body temperature at
the time of aneurysm clip application. The patients, neurosurgeons, neurological
examiners and study coordinators are blinded to the group assignments.
Outcome is assessed (using Glasgow outcome score, NIH Stroke Score (NIHSS),
Rankin disability score, Barthel’s Activities of daily living score,
Mini Mental State Examination and a 5 test battery of neuropsychological
function) 3 months after surgery, which is the end point of IHAST trial.
We propose to administer a more comprehensive, 8 -test battery of neuropsychological
function, to a subset of English speaking patients enrolled in IHAST,
and extend their period of follow up to 15 months. Patients will be recruited
for this study, at the time of last visit for IHAST. In consenting patients,
an assessment of neuropsychological function will be done at 3, 9 and
15 months after surgery. Neuropsychologists, administering / scoring these
tests will be blinded to the group assignment (hypothermia / normothermia)
and location of the aneurysm. The effect of hypothermia and location of
aneurysm (anterior communicating, anterior cerebral, middle cerebral,
posterior communicating and basilar arteries) on performance and rate
of change in neuropsychological function will be studied by appropriate
statistical analyses.
CFAAST is supported by a grant from the National Institutes of Health.
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