Premium
Bemiparin for thromboprophylaxis after benign gynecologic surgery: a randomized clinical trial
Author(s) -
Alalaf S. K.,
Jawad A. K.,
Jawad R. K.,
Ali M. S.,
Al Tawil N. G.
Publication year - 2015
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/jth.13164
Subject(s) - medicine , randomized controlled trial , intermittent pneumatic compression , odds ratio , pulmonary embolism , deep vein , confidence interval , thrombosis , surgery , low molecular weight heparin
Summary Background Venous thromboembolism ( VTE ) is the leading cause of mortality and morbidity in women following gynecologic surgery. Objectives To determine the efficacy of a second‐generation low molecular weight heparin (bemiparin) for thromboprophylaxis after benign gynecologic surgery. Methods We performed a single‐blind randomized controlled trial including women in the moderate‐risk, high‐risk and highest‐risk groups for developing VTE after benign gynecologic surgery. Participants were randomized at a 1 : 1 ratio into parallel groups to receive either seven daily doses of 3500 IU of subcutaneous bemiparin or to a non‐intervention group receiving standard rehydration and advice on ambulation. Participants were followed up for 7 days and 30 days postoperatively for symptomatic VTE , which was confirmed by compression Doppler ultrasound, magnetic resonance imaging, or computed tomographic pulmonary angiography, according to the type of VTE . Results In total, 387 participants were randomized to the bemiparin group and 387 to the non‐intervention group. The incidence of symptomatic VTE (deep vein thrombosis and pulmonary embolism) events was lower (0/377) in participants who received bemiparin than in those who received no pharmacologic intervention (12/380, 3.2%; 95% confidence interval [ CI ] 0.002–0.6). Logistic regression analysis showed significant associations between VTE and immobility (odds ratio [ OR ] 7.1; 95% CI 1.3–36.2), varicose veins ( OR 16.8; 95% CI 3.1–76.2), and thrombophilia ( OR 39.3; 95% CI 1.5–1006.7). There were no major bleeding events or side effects related to the use of bemiparin. Conclusions Bemiparin was an effective thromboprophylactic agent for preventing venous thrombosis after benign gynecologic surgery.