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Pilot study to test the efficacy and safety of activated recombinant factor VII (NovoSeven) in the treatment of refractory hemorrhagic cystitis following high-dose chemotherapy

Bone Marrow Transplantation volume 38, pages 825–828 (2006)Cite this article

Hemorrhagic cystitis (HC) is a known complication of high-dose cyclophosphamide chemotherapy.1 Approximately 5% of patients undergoing stem cell transplantation (SCT) develop severe HC, which may lead to urinary obstruction, acute renal failure, hydronephrosis, bladder perforation and death.2 Treatment of patients with HC is frequently unsatisfactory, and mainly consists of supportive measures.1

High-dose activated recombinant factor VII (rFVIIa/NovoSeven, NovoNordisk A/S, Bagsværd, Denmark) is a hemostatic agent approved for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors. rFVIIa has been evaluated as a pro-hemostatic agent in a variety of other hemorrhagic conditions,3 including hemorrhage in the setting of SCT.4, 5, 6 We report the result of a pilot study to test the efficacy of rFVIIa in HC.

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Acknowledgements

The study was funded by NovoNordisk Pharmaceuticals Inc., Princeton, NJ, USA, which also supplied the study drug. Dr Ashrani is a recipient of mentored patient-oriented research career development award (K-23 HL069203) from the National Heart, Lung and Blood Institute, NIH. We would like to thank the research nurse coordinators, Ms Joan Osip at University of Minnesota Medical Center-Fairview, Ms Carol Krasnov at the University of North Carolina, Chapel Hill and Ms Carrie Ma at MD Anderson Cancer Center for their untiring help and support.

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Author notes

  1. A A Ashrani

    Present address: Department of Internal Medicine, Division of Hematology, Mayo Clinic College of Medicine, Rochester, MN, USA

  2. N S Key

    Present address: Bone Marrow Transplant Program, Fox Chase – Temple University, Philadelphia, PA, USA

  3. J L Gajewski

    Present address: Department of Medicine, Division of Hematology, University of North Carolina, Chapel Hill, NC, USA

Authors and Affiliations

  1. Department of Medicine, University of Minnesota, Minneapolis, MN, USA

    A A Ashrani, D J Weisdorf & N S Key

  2. Department of Medicine, University of North Carolina, Chapel Hill, NC, USA

    D A Gabriel

  3. Department of Medicine, MD Anderson Cancer Center, Houston, TX, USA

    J L Gajewski

  4. Department of Epidemiology, University of Minnesota, Minneapolis, MN, USA

    D R Jacobs Jr

Authors
  1. A A Ashrani
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  2. D A Gabriel
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  3. J L Gajewski
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  5. D J Weisdorf
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  6. N S Key
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Correspondence to A A Ashrani.

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Ashrani, A., Gabriel, D., Gajewski, J. et al. Pilot study to test the efficacy and safety of activated recombinant factor VII (NovoSeven) in the treatment of refractory hemorrhagic cystitis following high-dose chemotherapy. Bone Marrow Transplant 38, 825–828 (2006). https://doi.org/10.1038/sj.bmt.1705535

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