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

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(4)/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.

journal_name

Surg Today

journal_title

Surgery today

authors

Hata T,Yasui M,Murata K,Okuyama M,Ohue M,Ikeda M,Ueshima S,Kitani K,Hasegawa J,Tamagawa H,Fujii M,Ohkawa A,Kato T,Morita S,Fukuzaki T,Mizushima T,Sekimoto M,Nezu R,Doki Y,Mori M,Multi-Center Clinical Study Group o

doi

10.1007/s00595-014-0911-7

subject

Has Abstract

pub_date

2014-11-01 00:00:00

pages

2116-23

issue

11

eissn

0941-1291

issn

1436-2813

journal_volume

44

pub_type

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