Objective: Identification of risk factors for bleeding and prospective
evaluation of two bleeding risk scores in the treatment of acute veno
us thromboembolism. Design: Secondary analysis of a prospective, rando
mized, assessor-blind, multicenter clinical trial. Setting: One univer
sity and 2 regional teaching hospitals. Patients: 188 patients treated
with heparin or danaparoid for acute venous thromboembolism. Measurem
ents: The presenting clinical features, the doses of the drugs, and th
e anticoagulant responses were analyzed using univariate and multivari
ate logistic regression analysis in order to evaluate prognostic facto
rs for bleeding. In addition, the recently developed Utrecht bleeding
risk score and Landefeld bleeding risk index were evaluated prospectiv
ely. Results: Major bleeding occurred in 4 patients (2.1%) and minor b
leeding in 101 patients (53.7%). For all (major and minor combined) br
eeding, body surface area less than or equal to 2 m(2) (odds ratio 2.3
, 95% CI. 1.2-4.4; p = 0.01), and malignancy (odds ratio 2.4, 95% CI 1
.1-4.9, p = 0.02) were confirmed to be independent risk factors. An in
creased treatment-related risk of bleeding was observed in patients tr
eated with high doses of heparin, independent of the concomitant activ
ated partial thromboplastin time ratios. Both bleeding risk scores had
low diagnostic value for bleeding in this sample of mainly minor blee
ders. Conclusions: A small body surface area and malignancy were assoc
iated with a higher frequency of bleeding. The bleeding risk scores me
rely offer the clinician a general estimation of the risk of bleeding.
In patients with a small body surface area or in patients with malign
ancy, it may be of interest to study whether limited dose reduction of
the anticoagulant drug may cause less bleeding without affecting effi
cacy.