Reliability of hematoma volume measurement at local sites in a multicenter acute intracerebral hemorrhage clinical trial.

نویسندگان

  • Haitham M Hussein
  • Nauman A Tariq
  • Yuko Y Palesch
  • Adnan I Qureshi
چکیده

BACKGROUND AND PURPOSE 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. RESULTS Fifty-six subjects were analyzed (mean age 62±15 years; 45% women). On-site HV values showed a significantly lower correlation with the MIPAV HV (r=0.63) than central HV and MIPAV HV (r=0.93) values. The correlation between on-site HV and central HV values was modest (r=0.51). A total of 73% of the central HVs were within 25% of the corresponding MIPAV HVs, whereas only 46% of the on-site HVs were within 25% of the corresponding MIPAV HVs (P<0.001). One protocol violation occurred as a result of inaccuracy of on-site HV measurement. CONCLUSIONS On-site HV measurements showed high variability, but the impact on the eligibility determination was small. Centralized remeasurements of HVs with feedback to the sites may increase the reliability of the on-site HV measurements.

برای دانلود رایگان متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Clinical re-evaluation of removing blood stasis therapy in treating acute intracerebral hemorrhage safety and efficacy: a protocol for a randomized, controlled, multicenter study (CRRICH Trial)

BACKGROUND Hypertensive intracerebral hemorrhage (HICH) is one of the most devastating forms of stroke. Currently, no specific therapies for HICH except general medical care. However, in China, medicine of promoting blood circulation (PBC) and removing blood stasis (RBS) are widely and efficiently used to treat HICH and become a potentially effective treatment for the secondary effects of HICH ...

متن کامل

The relationship between the serum levels of ferritin and the radiological brain injury indices in patients with spontaneous intracerebral hemorrhage

Objective(s): Preclinical studies show that iron plays a key role in mediating neuronal injury. This study was performedin order to identify the relationship between the serum level of ferritin and severity of the brain injury which occur after an Intracerebral hemorrhage (ICH). Materials and Methods:This was a cross sectional descriptive – analytic study, which was conducted on those patients ...

متن کامل

Radiologic estimation of hematoma volume in intracerebral hemorrhage trial by CT scan.

BACKGROUND AND PURPOSE Therapeutic intervention during the early stages of an intracerebral hemorrhage (ICH) might have value in improving clinical outcomes. During the 73-site International Recombinant Activated Factor VII Intracerebral Hemorrhage Trial, CT techniques were used to monitor the change in hematoma volume in response to treatment. The use of CT imaging technology served 3 function...

متن کامل

Earlier blood pressure-lowering and greater attenuation of hematoma growth in acute intracerebral hemorrhage: INTERACT pilot phase.

BACKGROUND AND PURPOSE The INTEnsive blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT) pilot study showed that early intensive blood pressure-lowering can attenuate hematoma growth in acute intracerebral hemorrhage. The present analysis aimed to determine the treatment effects on hematoma growth by time from intracerebral hemorrhage onset to randomization. METHODS Patient...

متن کامل

Magnitude of Hematoma Volume Measurement Error in Intracerebral Hemorrhage.

BACKGROUND AND PURPOSE Limiting intracerebral hemorrhage (ICH) and intraventricular hemorrhage (IVH) expansion is a common target for acute ICH studies and, therefore, accurate measurement of hematoma volumes is required. We investigated the amount of hematoma volume difference between computed tomography scans that can be considered as measurement error. METHODS Five raters performed baselin...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

عنوان ژورنال:
  • Stroke

دوره 44 1  شماره 

صفحات  -

تاریخ انتشار 2013