Effects of intravenous human albumin, enteral cilostazol, and combination therapy on the reduction of delayed cerebral ischemia in patients with aneurysmal subarachnoid hemorrhage - Summary - MDSpire
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Effects of intravenous human albumin, enteral cilostazol, and combination therapy on the reduction of delayed cerebral ischemia in patients with aneurysmal subarachnoid hemorrhage
To estimate the plausible effects of albumin, cilostazol, and combination therapy on reducing delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (aSAH).
Approach:
Treatment Classes: Defined four treatment classes: control, albumin-only, cilostazol-only, and combination therapy.
Primary Endpoint: National Institute of Neurological Disorders and Stroke Common Data Elements-defined DCI (CDE-d-DCI) on CT on days 10 to 14.
Simulation Model: Used a prior-predictive Monte Carlo model based on historical data to estimate treatment effects.
Key Findings:
Median absolute risk reductions (ARRs) versus control were 9.1 percentage points for albumin (90% simulation interval, −3.3 to 18.1; prior-predictive probability of ARR > 0, 89.8%), 18.1 percentage points for cilostazol (11.0 to 25.4; 99.9%), and 21.7 percentage points for combination therapy (12.4 to 29.9; 99.8%).
The incremental benefit of adding albumin to cilostazol was small and uncertain at 3.5 percentage points (−3.0 to 8.9).
The additive interaction effect was also uncertain, showing a potential reduction of 5.5 percentage points (−11.9 to 2.8).
Interpretation:
The simulations provide planning-level projections and do not establish efficacy.
Limitations:
The study does not analyze observed outcomes.
Estimates are conditional on specified priors and model structure.
Conclusion:
The findings support the need for further randomized controlled trials to evaluate the effects of cilostazol and albumin.
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