Safety of fondaparinux to prevent venous thromboembolism in Japanese patients undergoing colorectal cancer surgery: a multicenter study

Taishi Hata, Masayoshi Yasui, Kohei Murata, Masaki Okuyama, Masayuki Ohue, Masataka Ikeda, Shigeyuki Ueshima, Kotaro Kitani, Junichi Hasegawa, Hiroshi Tamagawa, Makoto Fujii, Atsushi Ohkawa, Takeshi Kato, Shunji Morita, Takayuki Fukuzaki, Tsunekazu Mizushima, Mitsugu Sekimoto, Riichiro Nezu, Yuichiro Doki, Masaki Mori

研究成果: Contribution to journalArticle査読

9 被引用数 (Scopus)

抄録

Purpose: To investigate the safety and efficacy of fondaparinux (FPX) for venous thromboembolism (VTE) prophylaxis in Japanese patients undergoing colorectal cancer surgery.

Methods: The subjects of this multicenter, open-label, prospective observational study were patients undergoing resection of the colon/rectum for colorectal cancer. All patients were given FPX 2.5 or 1.5 mg by subcutaneous injection, once daily for 4–8 days, starting 24 h after surgery. The primary endpoint was any major bleeding event and the secondary endpoint was any symptomatic VTE event.

Results: Between February 2009 and December 2010, 619 patients from 23 institutions were enrolled in this study. The median duration of FPX prophylaxis was 4 days. The incidence of major bleeding was 0.81 % [5/619, 95 % confidence interval (CI) 0.3–1.9] and the incidence of minor bleeding was 9.5 % (59/619, 95 % CI 7.3–12.1). There was no fatal bleeding or symptomatic VTE. Multivariable analysis revealed the following to be risk factors for bleeding events: preoperative platelet count <15 × 104/µl [odds ratio (OR) 4.521], male sex (OR 2.078), and blood loss during surgery <50 ml (OR 2.019).

Conclusion: The administration of 2.5/1.5 mg FPX 24 h after colorectal cancer surgery is safe and effective.

本文言語英語
ページ(範囲)2116-2123
ページ数8
ジャーナルSurgery today
44
11
DOI
出版ステータス出版済み - 10 11 2014
外部発表はい

All Science Journal Classification (ASJC) codes

  • Surgery

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