Reliability of Hematoma Volume Measurement at Local Sites in a Multicenter Acute Intracerebral Hemorrhage Clinical Trial

The reliability of hematoma volume (HV) measurement using the ABC/2 method in multicenter clinical trials is unknown. We determined the accuracy of ABC/2 method as an on-site test in comparison with the gold standard central HV-assessment and semiautomatic HV-assessment. Method- We analyzed data from an acute intracerebral hemorrhage multicenter clinical trial. HV was measured by site investigators to determine enrollment eligibility (<60 cm(3)) using the ABC/2 method (on-site HV), and independently by the core-imaging laboratory using computer-based analysis (Medical Image Processing, Analysis, and Visualization [MIPAV] HV). HV was also measured by ABC/2 method (central HV) at the core-imaging laboratory to assess the difference in measurements between on-site (multiple raters with variable experiences) and central (single experienced rater) HVs.