Risk of bleeding during anticoagulant treatment for venous thromboembolism
With the use of 3 easily obtainable, clinical variables, this prediction model identifies a subgroup of patients at the start of anticoagulant therapy who have a high risk of developing hemorrhagic complications.
Research authors: Kuijer PM, Hutten BA, Prins MH, and Büller HR.
Details Custom formula Study characteristics Files & References
★★★★
Model author
Model ID
1402
Version
1.14
Revision date
2018-06-27
MeSH terms
  • Anticoagulant Drugs
  • Bleeding
  • Hemorrhage
  • Venous Thromboembolism
  • Clinical Prediction Rule
  • Model type
    Custom model (Conditional)
    Status
    public
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    Condition Formula

    Additional information

    Development cohort:
    Data for the analysis were derived from the database of the Columbus Investigators study. Briefly, in this study a total of 1021 consecutive patients with objectively confirmed VTE were randomly allocated to receive an initial treatment with either subcutaneous low-molecular-weight heparin 175 anti-factor Xa U/kg twice daily, or continuous intravenous unfractionated heparin. Both treatment groups received oral anticoagulant therapy (warfarin sodium or coumarin), which started on the first or second day of treatment, for at least 3 months, with a targeted therapeutic INR of 2.0 to 3.0.

    Outcomes:
    Study outcomes evaluated during a 3-month follow-up period were the incidence of symptomatic recurrent VTE, which was confirmed by objective investigations, and the incidence of bleeding complications. All outcomes were assessed by an independent adjudication committee that was unaware of treatment allocation. Bleeding was defined as major if it was clinically overt and associated with a decline in hemoglobin concentration of at least 20 g/L, if there was a need for transfusion of 2 U or more of red blood cells, if it was retroperitoneal or intracranial, or if it warranted permanent discontinuation of treatment.

    Test group:
    The constructed score was evaluated in a subset of 241 patients (the test group) to determine the optimal cutoff points for the prediction of all hemorrhagic complications as well as major bleeding complications using receiver operating characteristic curves. Three groups were defined: those at low, moderate, or high risk of bleeding complications during the 3-month period of anticoagulant treatment. Data from the test group were used to investigate whether the score could be optimized or further simplified without loss of accuracy.

    Validation group: 
    the score with the defined cutoff points was validated in the remaining 780 patients in the trial. In this phase, both the original and the simplified score were evaluated.
     

    Study Population

    Total population size: 241
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    Females: {{ model.numberOfFemales }}

    Continuous characteristics

    Name Mean SD Unit
    Age 63 17 years
    Height 171 10 cm
    Weight 73 16 kg

    Categorical characteristics

    Name Subset / Group Nr. of patients
    Diagnosis at presentation Pulmonary embolism 80
    Deep vein thrombosis 161
    Medical history Known malignancy 57
    Recent surgery 49
    Recent trauma 19
    Outcomes at follow-up Recurrent VTE 13
    All bleeding complications 22
    Major bleeding 9

    Related files

    No related files available

    Total risk score:
    ...
    points

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    Result
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    Total risk score: points

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    Outcome stratification

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    Conditional information

    Result interpretation

    Clinical implications:
    The findings of the underlying study by Kuijer et al (1999) indicate that with several simple, easily obtainable clinical variables, it is possible to identify a subgroup of patients at the start of anticoagulant therapy who have a high risk of developing hemorrhagic complications.

    Model performance: 
    In patients treated for VTE, our model categorized approximately one fifth of the patients to be at high risk for bleeding complications. In this group, the incidence of all bleeding complications during anticoagulant therapy was 17%, of which more than one third met the criteria for major bleeding. These rates were about 6 to 7 times higher than the rates observed in those identified as low risk. This difference in bleeding incidence was not due to differences in the intensity of anticoagulant treatment among the various risk categories.

    Source:

    1. Kuijer PM, Hutten BA, Prins MH, et al. Prediction of the risk of bleeding during anticoagulant treatment for venous thromboembolism. Arch Intern Med. 1999;159(5):457-60.

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    Calculations alone should never dictate patient care, and are no substitute for professional judgement. See our full disclaimer.

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