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Recombinant activated factor VII (rFVIIa/NovoSeven®) in the management of severe postpartum haemorrhage: initial report of a multicentre case series in Japan

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Abstract

Only a limited number of case reports documenting the off-label use of recombinant factor VIIa (rFVIIa) in Japanese patients with postpartum haemorrhage (PPH) have been published. Data on Japanese cases with severe PPH in which rFVIIa was administered were collected. Data of obstetric haemorrhage patients treated with rFVIIa between 2005 and 2010 were retrospectively collected throughout Japan. The data included patients’ background information, blood product requirements, dose/timing of rFVIIa, and adverse effects. Treating clinicians subjectively assessed the effect of rFVIIa on bleeding at each administration using four categories: “Stopped”, “Decreased”, “Unchanged”, and “Increased”. A total of 25 women received rFVIIa for the treatment of obstetric haemorrhage in 18 institutions. After the final administration, bleeding was “stopped” in 16 patients (64%), “decreased” in eight patients (32%), and “unchanged” in one patient (4%). A significant reduction in blood product requirement was observed following the first rFVIIa administration. Hysterectomy was required in two patients (15.4%) after rFVIIa administration. Four asymptomatic thrombotic events were reported in three patients. These results suggest that rFVIIa can be a beneficial therapeutic option that can reduce blood loss and prevent hysterectomy in Japanese patients with massive obstetric bleeding.

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Acknowledgments

The authors would like to thank Dr. Phillips of the committee of Australian and New Zealand Haemostasis Registry (the ANZHR) for his valuable help in planning this registry. Editorial assistance was provided by N Kikuchi, Clinical Study Support, Inc., Nagoya, Japan.

Conflict of interest

Dr. Kobayashi has financial relationships with Novo Nordisk, CSL Behring, and Benesis. Dr. Nakabayashi has a financial relationship with CSL Behring, and he is a committee member of the blood institution of the Japanese Red Cross Society. Dr. Yoshioka has financial relationships with Baxter and Novo Nordisk.

Author information

Authors and Affiliations

  1. Hamamatsu Medical Center, 328 Tomitsuka-cho, Naka-ku, Hamamatsu, Shizuoka, 432-8580, Japan

    Takao Kobayashi

  2. Aiiku Maternal and Child Health Center, 5-6-8 Minami Azabu, Minato-ku, Tokyo, Japan

    Masao Nakabayashi

  3. Nara Medical University, 840 Shijo-cho, Kashihara, Nara, Japan

    Akira Yoshioka

  4. Department of Obstetrics and Gynecology, Mie Chuo Medical Center, 2158-5 Hisai Myojin-cho, Tsu, Mie, Japan

    Makoto Maeda

  5. University of Miyazaki Hospital, 5200 Kihara, Kiyotake, Miyazaki, Miyazaki, Japan

    Tsuyomu Ikenoue

Authors
  1. Takao Kobayashi
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  2. Masao Nakabayashi
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  3. Akira Yoshioka
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  4. Makoto Maeda
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  5. Tsuyomu Ikenoue
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Corresponding author

Correspondence to Takao Kobayashi.

Appendix: Participating physician

Appendix: Participating physician

Shohei Okada, Kurashiki Medical Center; Yoshikazu Goto, Kanazawa University Hospital; Tomoyoshi Nohira, Hachioji Medical Center of Tokyo Medical University; Nobukazu Sato, Kawasaki Municipal Kawasaki Hospital; Takashi Shoda, Kitasato University Hospital; Jun Murotsuki, Tohoku University Hospital; Satoshi Ohira, Shinshu University Hospital; Tomohisa Sakashita, Hiroshima University Hospital; Seiji Inoue, Okayama University Hospital; Masato Nakayama, Saitama Medical Center; Akitoshi Nakashima, Toyama University Hospital; Rei Sunai & Mayuko Komuro, University of Yamanashi; Kiyonori Miura, Nagasaki University Hospital; Ken Miyazaki, Japanese Red Cross Nagoya Daiichi Hospital; Tsutomu Shichino, National Hospital Organization Kyoto Medical Center; Ryu Matsuoka, Showa University Hospital; Takashi Ozaki, Hirosaki University Hospital; Masayuki Ito, Tottori University Hospital.

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Kobayashi, T., Nakabayashi, M., Yoshioka, A. et al. Recombinant activated factor VII (rFVIIa/NovoSeven®) in the management of severe postpartum haemorrhage: initial report of a multicentre case series in Japan. Int J Hematol 95, 57–63 (2012). https://doi.org/10.1007/s12185-011-0974-9

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  • DOI: https://doi.org/10.1007/s12185-011-0974-9

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