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The observation of bleeding complications in haemato-oncological patients: stringent watching, relevant reporting.
MedLine Citation:
PMID:  23036067     Owner:  NLM     Status:  Publisher    
BACKGROUND: The reported percentage of haemato-oncological patients experiencing bleeding complications is highly variable, ranging from 5 to 70%, posing a major problem for comparison of clinical platelet transfusion trials using bleeding complications as a primary endpoint. In a pilot study we assessed the impact of the design of scoring of bleeding on the percentage of patients with WHO grade 2 or higher bleeding grades. STUDY DESIGN AND METHODS: We performed a prospective, observational study using a rigorous bleeding observation system in thrombocytopenic patients with haemato-oncological disorders. Endpoints of the study were the percentage of patients and days with bleeding WHO grade ≥ 2 comparing designs in which skin bleeding represent a continuation of a previous bleed or a new bleed. RESULTS: In four participating hospitals 64 patients suffering 870 evaluable thrombocytopenic days (platelet count < 80 × 10(9)  L(-1) ) were included. At least one episode of bleeding grade ≥ 2 occurred in 36 patients (56%). Most grade 2 bleeding complications occurred mucocutaneously. The percentage of days with bleeding of grade ≥ 2 was 16% but decreases to 8% when only newly developed skin bleeding was included. CONCLUSION: Rigorous daily observation results in a bleeding incidence that is comparable to recent reportings applying the same method. The results of this study show that censoring for stable skin bleeding has a profound effect on bleeding incidence per day. The clinical relevance of rigorous or clinically judged bleeding scores as an endpoint remains to be defined.
P F Ypma; J-L H Kerkhoffs; J A van Hilten; R A Middelburg; M Coccoris; J J Zwaginga; E M Beckers; R Fijnheer; P F van der Meer; A Brand
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-10-5
Journal Detail:
Title:  Transfusion medicine (Oxford, England)     Volume:  -     ISSN:  1365-3148     ISO Abbreviation:  Transfus Med     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-5     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9301182     Medline TA:  Transfus Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2012 The Authors. Transfusion Medicine © 2012 British Blood Transfusion Society.
Department of Haematology, HAGA Teaching Hospital Den Haag, The Hague, The Netherlands; Sanquin-Jon J van Rood, Centre for Clinical Transfusion Research, Sanquin Research, Leiden, The Netherlands.
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