Brain Edema at Cerebral Hemorrhage (BEACH) Study

  • Majidi, Shahram (PI)

Project Details

Description

The primary aim of this study is to determine the frequency of global cerebral edema occurrence and identify associated factors and effect on outcome in patients with intracerebral hemorrhage (ICH). Global cerebral edema volume will be determined by subtracting the hematoma and perihematomal edema volumes from the total brain volume using a previously described method. The study will utilize clinical data and CT scans collected at standard time points for ICH patients enrolled in the multi-center, randomized, controlled, Phase III trial with blinded outcome ascertainment ATACH II trial. The primary hypothesis of the ATACH II trial is that intensive systolic blood pressure (SBP) reduction (SBP ≤140mmHg -- hereafter referred to as the intensive treatment) using intravenous (IV) nicardipine with treatment initiated within 4.5 hours of onset of ICH and continued for the next 24 hours reduces the likelihood of death or disability at 3 months after ICH (defined by modified Rankin scale [mRS] score of 4-6) by 10% or greater (absolute difference) compared with standard SBP reduction (SBP ≤180mmHg -- hereafter referred to as the standard treatment). The proposed project is a natural extension of numerous experimental and clinical series demonstrating the occurrence and prognostic significance of neuronal and glial death and blood brain barrier breakdown in the hemisphere contralateral to the affected hemisphere in patients with ICH. We hypothesize that global cerebral edema is associated with death and disability at 3 months among patients with ICH and the association is independent of known predictors including admission Glasgow Coma Scale (GCS) score, hematoma volume, and presence of intraventricular hemorrhage. We further hypothesize that global cerebral edema occurs with lower frequency (10% absolute difference) among subjects who had intensive SBP treatment, which is defined as systolic blood pressure reduction to ≤ 140mmHg. (AHA Program: Mentored Clinical & Population Research Program)

StatusFinished
Effective start/end date1/07/1330/06/15

Funding

  • American Heart Association: $154,000.00

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