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January NaN, 2002

Use of Anticoagulants in Patients With Sepsis—Reply

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthor

JAMA. 2002;287(4):448-449. doi:10.1001/jama.287.4.447

In Reply: As we pointed out, heparin alone may have potential therapeutic benefits for patients with sepsis. However, this question was not specifically addressed in our study. Heparin use for prophylaxis against venous thrombosis was allowed by the protocol at the discretion of the individual investigator. The randomization process did not account for its use and heparin administration was principally initiated as a postrandomization event.

Assessment of the independent capacity of postrandomization interventions to affect outcome in a clinical study is fraught with analytic pitfalls. The initiation of heparin therapy in each survivor necessitates moving a patient from the placebo group without heparin to the placebo group with heparin. This leads to a smaller denominator (and thereby increases the proportional rate of death) in the placebo group with no heparin. At the same time, each survivor treated with heparin adds to the denominator in the placebo group with heparin (and hence a lower mortality rate). Even if heparin had no effect on mortality, the calculated mortality rate would favor the heparin treatment over placebo without heparin. In other words, patients who die from septic shock in the early phases of the study are not available to be subsequently treated with heparin.

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