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Reporting the NAFT Major Bleeding Rates in Context: Reviewers Should Include Site InvestigatorClassified Rates
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In their article, Strebel and colleagues1 report a systematic review assessing the relative efficacy and safety of low-molecular-weight heparins used to prevent thrombosis after total hip replacement. The authors comment that for the double-blind North American Fragmin Trial (NAFT),2 "This relatively low incidence of thrombosis is offset by a relatively high rate of major bleeding of 8.8% in the early preoperative group and 6.8% in the early postoperative group."1 The authors further note that "The rates of bleeding in both of these perioperative groups are higher" than their pooled preoperative and postoperative data or the perioperative data reported by Planes et al3 and Francis et al.4
It is important to note that NAFT was double-blind and reported bleeding rates separately based on centrally adjudicated major bleeding; site investigatorclassified major bleeding; and site investigatorclassified serious bleeding. Strebel et al1 have failed to include or comment on the site investigatorclassified major and . . . [Full Text of this Article]
RELATED ARTICLE
Reporting the NAFT Major Bleeding Rates in Context: Reviewers Should Include Site InvestigatorClassified Rates
Niklaus Strebel, Martin H. Prins, and Harry R. Büller
Arch Intern Med. 2003;163(3):369.
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