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- Title
Safety of fondaparinux to prevent venous thromboembolism in Japanese patients undergoing colorectal cancer surgery: a multicenter study.
- Authors
Hata, Taishi; Yasui, Masayoshi; Murata, Kohei; Okuyama, Masaki; Ohue, Masayuki; Ikeda, Masataka; Ueshima, Shigeyuki; Kitani, Kotaro; Hasegawa, Junichi; Tamagawa, Hiroshi; Fujii, Makoto; Ohkawa, Atsushi; Kato, Takeshi; Morita, Shunji; Fukuzaki, Takayuki; Mizushima, Tsunekazu; Sekimoto, Mitsugu; Nezu, Riichiro; Doki, Yuichiro; Mori, Masaki
- Abstract
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 × 10/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.
- Subjects
JAPAN; WOUNDS &; injuries; THROMBOSIS; RESPIRATORY therapist &; patient; THROMBOEMBOLISM risk factors; PATIENTS' rights
- Publication
Surgery Today, 2014, Vol 44, Issue 11, p2116
- ISSN
0941-1291
- Publication type
Article
- DOI
10.1007/s00595-014-0911-7