TY - JOUR
T1 - Safety of fondaparinux to prevent venous thromboembolism in Japanese patients undergoing colorectal cancer surgery
T2 - a multicenter study
AU - Hata, Taishi
AU - Yasui, Masayoshi
AU - Murata, Kohei
AU - Okuyama, Masaki
AU - Ohue, Masayuki
AU - Ikeda, Masataka
AU - Ueshima, Shigeyuki
AU - Kitani, Kotaro
AU - Hasegawa, Junichi
AU - Tamagawa, Hiroshi
AU - Fujii, Makoto
AU - Ohkawa, Atsushi
AU - Kato, Takeshi
AU - Morita, Shunji
AU - Fukuzaki, Takayuki
AU - Mizushima, Tsunekazu
AU - Sekimoto, Mitsugu
AU - Nezu, Riichiro
AU - Doki, Yuichiro
AU - Mori, Masaki
N1 - Funding Information:
We thank Dr. Hiroshi Kobayashi of the Department of Obstetrics and Gynecology, Nara Medical University, and Dr. Mashio Nakamura of the Department of Clinical Cardiovascular Research, Mie University Graduate School of Medicine, for acting as the safety and efficacy committee for this study. This study was supported by The Supporting Center for Clinical Research and Education.
Publisher Copyright:
© 2014, The Author(s).
PY - 2014/10/11
Y1 - 2014/10/11
N2 - 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.
AB - 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.
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U2 - 10.1007/s00595-014-0911-7
DO - 10.1007/s00595-014-0911-7
M3 - Article
C2 - 24840400
AN - SCOPUS:84919329487
SN - 0941-1291
VL - 44
SP - 2116
EP - 2123
JO - Surgery Today
JF - Surgery Today
IS - 11
ER -
