title: The observation of bleeding complications in haemato-oncological patients: stringent watching, relevant reporting.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Haematology, HAGA Teaching Hospital Den Haag, The Hague, The Netherlands. p.ypma@sanquin.nl
authors.forename: P F
authors.initials: PF
authors.lastname: Ypma
authors.forename: J-L H
authors.initials: JL
authors.lastname: Kerkhoffs
authors.forename: J A
authors.initials: JA
authors.lastname: van Hilten
authors.forename: R A
authors.initials: RA
authors.lastname: Middelburg
authors.forename: M
authors.initials: M
authors.lastname: Coccoris
authors.forename: J J
authors.initials: JJ
authors.lastname: Zwaginga
authors.forename: E M
authors.initials: EM
authors.lastname: Beckers
authors.forename: R
authors.initials: R
authors.lastname: Fijnheer
authors.forename: P F
authors.initials: PF
authors.lastname: van der Meer
authors.forename: A
authors.initials: A
authors.lastname: Brand
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D019337:Hematologic Neoplasms / Q000097:blood / Q000150:complications / Q000453:epidemiology / Q000628:therapy; D006470:Hemorrhage / Q000097:blood / Q000453:epidemiology / Q000209:etiology / Q000628:therapy; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D017713:Platelet Transfusion; D011446:Prospective Studies; D013921:Thrombocytopenia / Q000097:blood / Q000453:epidemiology / Q000209:etiology / Q000628:therapy