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 Todayjournal_title
Surgery todayauthors
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 odoi
10.1007/s00595-014-0911-7subject
Has Abstractpub_date
2014-11-01 00:00:00pages
2116-23issue
11eissn
0941-1291issn
1436-2813journal_volume
44pub_type
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