Abstract |
A randomized, double-blind multicenter trial was performed to compare the safety and efficacy of a new low-molecular-weight heparin ( LMWH) ( LU 47311, Clivarine) and standard unfractionated heparin for the prophylaxis of postoperative venous thromboembolism. Altogether 1351 patients scheduled to undergo abdominal surgery were included. Main outcome measures included the incidence of thromboembolic events ( deep vein thrombosis, pulmonary embolism, or both) and bleeding complications, including wound hematoma. A total of 655 patients received 1750 anti-Xa IU of LMWH plus a placebo injection daily; 677 patients received 5000 IU of unfractionated heparin (UFH) twice a day. Both drugs were found to be equally effective, as 4.7% of patients in the LMWH group and 4.3% in the UFH group developed postoperative thromboembolic complications. However, the incidence of bleeding complications was significantly reduced in the LMWH group: 55 (8.3%) patients in the LMWH group and 80 (11.8%) in the UFH group developed bleeding complications, a relative risk (RR) of 0.70 (95% CI 0.51-0.97;p = 0.03); wound hematoma occurred in 29 (4.4%) of the LMWH group compared with 55 (7.7%) in those in the UFH group for an RR of 0.57 (95% CI 0.37-0.88;p = 0.01). This study confirmed that a very low dose of 1750 anti-Xa IU daily of this new LMWH is as effective as 10,000 IU of UFH for preventing postoperative deep vein thrombosis. At this dose its administration is associated with a significant reduction in the risk of bleeding including wound hematoma.
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Authors | V V Kakkar, O Boeckl, B Boneu, L Bordenave, O A Brehm, P Brücke, S Coccheri, A T Cohen, F Galland, S Haas, J Jarrige, K Koppenhagen, A LeQuerrec, E Parraguette, P Prandoni, J D Roder, M Roos, C Rüschemeyer, J R Siewert, H Vinazzer, E Wenzel |
Journal | World journal of surgery
(World J Surg)
Vol. 21
Issue 1
Pg. 2-8; discussion 8-9
(Jan 1997)
ISSN: 0364-2313 [Print] United States |
PMID | 8943170
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticoagulants
- Heparin, Low-Molecular-Weight
- reviparin
- Heparin
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Topics |
- Adult
- Aged
- Anticoagulants
(therapeutic use)
- Double-Blind Method
- Female
- Hemorrhage
(chemically induced)
- Heparin
(adverse effects, therapeutic use)
- Heparin, Low-Molecular-Weight
(adverse effects, therapeutic use)
- Humans
- Incidence
- Male
- Middle Aged
- Postoperative Complications
(mortality, prevention & control)
- Pulmonary Embolism
(mortality, prevention & control)
- Risk Factors
- Thromboembolism
(prevention & control)
- Thrombophlebitis
(epidemiology, prevention & control)
- Treatment Outcome
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