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Prophylaxis of catheter-related deep vein thrombosis in cancer patients with low-dose warfarin, low molecular weight heparin, or control: a randomized, controlled, phase III study

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Abstract

Purpose

Whether an anticoagulant prophylaxis is needed for patients with cancer with a central venous catheter is a highly controversial subject. We designed a study to compare different prophylactic strategies over 3 months of treatment.

Methods

We performed a phase III prospective, open-label randomized trial. After the insertion of a central venous access device, consecutive patients with planned chemotherapy for cancer were randomized to no anticoagulant prophylaxis, low molecular weight heparin [low molecular weight heparin (LMWH); with isocoagulation doses], or warfarin 1 mg/day. Treatments were given over the first 3 months. Doppler ultrasound and venographies were performed on days 1 and 90, respectively, or sooner in case of clinical presumption of thrombosis.

Results

A total of 420 patients were randomized, and 407 were evaluable. Forty-two catheter-related deep vein thrombosis (DVT) occurred (10.3 %), 20 in those with no anticoagulation, 8 in those receiving warfarin, and 14 in those receiving LMWH. Nine additional non-related catheter deep vein thrombosis (CDVT) occurred. Anticoagulation significantly reduced the incidence of catheter-related DVT (p = 0.035) and catheter non-related DVT (p = 0.007), with no difference between warfarin and LMWH. Safety was good (3.4 % of attributable events) but compliance with randomized prophylaxis was lower than expected.

Conclusions

Prophylaxis showed a benefit regarding catheter-related and non-catheter-related DVT with no increase in serious side effects.

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Acknowledgments

We acknowledge the Clinical Research and Innovation Direction (DRCI) of Limoges Hospital for its contribution to the study.

Conflict of interest

None.

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Authors and Affiliations

  1. Department of Medical Oncology, University Hospital, Limoges, France

    Sandrine Lavau-Denes, D. Genet, L. Vénat-Bouvet, J. L. Labourey, J. Martin, P. Slaouti & N. Tubiana-Mathieu

  2. Department of Thoracic and Cardiovascular Surgery and Angiology, University Hospital, Limoges, France

    P. Lacroix

  3. Department of Medical Imaging and Radiology, University Hospital, Limoges, France

    A. Maubon

  4. Unit of Clinical Research and Biostatistics, University Hospital, Limoges, France

    P. M. Preux

  5. INSERM U1094, University Limoges School of Medicine, Limoges, France

    P. M. Preux

  6. CNRS FR 3503 GEIST, University of Limoges, Limoges, France

    P. M. Preux

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  1. Sandrine Lavau-Denes
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  2. P. Lacroix
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  3. A. Maubon
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  4. P. M. Preux
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  7. J. L. Labourey
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  10. N. Tubiana-Mathieu
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Correspondence to Sandrine Lavau-Denes.

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Lavau-Denes, S., Lacroix, P., Maubon, A. et al. Prophylaxis of catheter-related deep vein thrombosis in cancer patients with low-dose warfarin, low molecular weight heparin, or control: a randomized, controlled, phase III study. Cancer Chemother Pharmacol 72, 65–73 (2013). https://doi.org/10.1007/s00280-013-2169-y

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