Clinical research studyLong-term Low-Molecular-Weight Heparin versus Usual Care in Proximal-Vein Thrombosis Patients with Cancer
Section snippets
Study Design
We used a multicenter, open-label randomized design and compared long-term subcutaneous low-molecular-weight heparin against usual-care initial intravenous heparin and long-term oral warfarin sodium for a therapy duration of 3 months in cancer patients with proximal-vein thrombosis. An evaluation of patients with cancer and proximal deep-vein thrombosis was planned prospectively as cancer patients were randomized separately within the Main-LITE population of patients. Patients with cancer and
Study Population
Two hundred patients were recruited and randomized to tinzaparin (100 patients) or usual-care anticoagulants (100 patients). Figure 1 shows the patient flow for the eligible patients and for those randomized to the treatment groups. The tinzaparin and usual-care groups were comparable at entry (Table 2). The study began in 1994 at 23 centers across Canada (Table 3). Due to difficulties with occasional patient follow-up, which were overcome, successful patient follow-up was completed in July
Discussion
Long-term therapeutic dose low-molecular-weight heparin, when compared with usual-care vitamin-K-antagonist therapy for cancer patients with acute proximal-vein thrombosis, offered improved efficacy against recurrent venous thromboembolism. The outcome measures were assessed during study therapy and at 1 year, because there is evidence that the impact of study therapy on outcome persists after therapy is discontinued.16, 40 Our results are consistent with those of a benchmark trial evaluating
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