Title |
Update of the Preventive Antibiotics in Stroke Study (PASS): statistical analysis plan
|
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Published in |
Trials, October 2014
|
DOI | 10.1186/1745-6215-15-382 |
Pubmed ID | |
Authors |
Willeke F Westendorp, Jan-Dirk Vermeij, Diederik W J Dippel, Marcel G W Dijkgraaf, Tom van der Poll, Jan M Prins, Frederique H Vermeij, Yvo B W E M Roos, Matthijs C Brouwer, Aeilko H Zwinderman, Diederik van de Beek, Paul J Nederkoorn |
Abstract |
Infections occur in 30% of stroke patients and are associated with unfavorable outcomes. Preventive antibiotic therapy lowers the infection rate after stroke, but the effect of preventive antibiotic treatment on functional outcome in patients with stroke is unknown. The PASS is a multicenter, prospective, phase three, randomized, open-label, blinded end-point (PROBE) trial of preventive antibiotic therapy in acute stroke. Patients are randomly assigned to either ceftriaxone at a dose of 2 g, given every 24 h intravenously for 4 days, in addition to standard stroke-unit care, or standard stroke-unit care without preventive antibiotic therapy. The aim of this study is to assess whether preventive antibiotic treatment improves functional outcome at 3 months by preventing infections. This paper presents in detail the statistical analysis plan (SAP) of the Preventive Antibiotics in Stroke Study (PASS) and was submitted while the investigators were still blinded for all outcomes. |
X Demographics
Geographical breakdown
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Unknown | 1 | 100% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 72 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Researcher | 14 | 19% |
Student > Master | 8 | 11% |
Student > Ph. D. Student | 6 | 8% |
Student > Bachelor | 6 | 8% |
Student > Doctoral Student | 5 | 7% |
Other | 10 | 14% |
Unknown | 23 | 32% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 24 | 33% |
Nursing and Health Professions | 4 | 6% |
Neuroscience | 4 | 6% |
Economics, Econometrics and Finance | 4 | 6% |
Mathematics | 3 | 4% |
Other | 5 | 7% |
Unknown | 28 | 39% |