The Biostatistical Core's (BSC) primary goal remains the same as the last submission which is to closely interact with the Principal Investigators (Pis) of the three projects, the Investigators of the clinical sites participating in Project I, the CLEARER trial, the Investigators of the clinical sites that will enroll patients in Project 2, the STOP-IT trial, and the Investigators in the basic science project, Project 3, TRUST, as well as NIH personnel.
The specific aims of the BSC are to: 1. Collaborate with all the investigators in the design of the investigations. 2. Prepare programs for adaptive randomization for the CLEARER and STOP-IT trials and monitor each on a continuous basis. 3. Provide a centralized information management system for collecting, entering, editing, storing, and analyzing data. This includes development of data collection forms on a web-based data entry system, a manual of operations, quality control procedures, security and confidentiality of data, and long-term storage for all projects. The web-based data-entry and communication system for the two SPOTRIAS clinical trials is a new addition from the previous five years. 4. Produce scheduled reports to the clinical sites and also prepare reports to the Data and Safety Monitoring Boards (DSMB). 5. Analyze each trial data, Projects 1 and 2, in collaboration with the Investigators including performing an interim analysis for Project 1, CLEARER. 6. Analyze the data from Project 3 in collaboration with the Principal Investigator and other participating investigators. 7. Participate in the closeout of each clinical trial. 8. Maintain the shared SPOTRIAS clinical subject database at UC for the SPOTRIAS Network and coordinate regular submission of data to the Central Data Storage facility.

National Institute of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Specialized Center (P50)
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Special Emphasis Panel (ZNS1)
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University of Cincinnati
United States
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Lees, Kennedy R; Selim, Magdy H; Molina, Carlos A et al. (2016) Early Versus Late Assessment of Stroke Outcome. Stroke 47:1416-9
Kandadai, Madhuvanthi A; Mukherjee, Prithviraj; Shekhar, Himanshu et al. (2016) Microfluidic manufacture of rt-PA -loaded echogenic liposomes. Biomed Microdevices 18:48
Adeoye, Opeolu; Sucharew, Heidi; Khoury, Jane et al. (2015) Combined Approach to Lysis Utilizing Eptifibatide and Recombinant Tissue-Type Plasminogen Activator in Acute Ischemic Stroke-Full Dose Regimen Stroke Trial. Stroke 46:2529-33
Chaisinanunkul, Napasri; Adeoye, Opeolu; Lewis, Roger J et al. (2015) Adopting a Patient-Centered Approach to Primary Outcome Analysis of Acute Stroke Trials Using a Utility-Weighted Modified Rankin Scale. Stroke 46:2238-43
Adeoye, Opeolu; Sucharew, Heidi; Khoury, Jane et al. (2015) Recombinant tissue-type plasminogen activator plus eptifibatide versus recombinant tissue-type plasminogen activator alone in acute ischemic stroke: propensity score-matched post hoc analysis. Stroke 46:461-4
Kandadai, Madhuvanthi A; Meunier, Jason M; Hart, Kimberley et al. (2015) Plasmin-loaded echogenic liposomes for ultrasound-mediated thrombolysis. Transl Stroke Res 6:78-87
Brandler, Ethan S; Sharma, Mohit; Sinert, Richard H et al. (2014) Prehospital stroke scales in urban environments: a systematic review. Neurology 82:2241-9
Zahuranec, Darin B; Lisabeth, Lynda D; Sánchez, Brisa N et al. (2014) Intracerebral hemorrhage mortality is not changing despite declining incidence. Neurology 82:2180-6
Lu, A; Wagner, K R; Broderick, J P et al. (2014) Administration of S-methyl-L-thiocitrulline protects against brain injuries after intracerebral hemorrhage. Neuroscience 270:40-7
Adeoye, Opeolu; Knight, William A; Khoury, Jane et al. (2014) A matched comparison of eptifibatide plus rt-PA versus rt-PA alone in acute ischemic stroke. J Stroke Cerebrovasc Dis 23:e313-5

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