PMID- 8943170 OWN - NLM STAT- MEDLINE DCOM- 19970409 LR - 20190826 IS - 0364-2313 (Print) IS - 0364-2313 (Linking) VI - 21 IP - 1 DP - 1997 Jan TI - Efficacy and safety of a low-molecular-weight heparin and standard unfractionated heparin for prophylaxis of postoperative venous thromboembolism: European multicenter trial. PG - 2-8; discussion 8-9 AB - 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. FAU - Kakkar, V V AU - Kakkar VV AD - Thrombosis Research Institute, Emmanuel Kaye Building, Manresa Road, Chelsea SW3 6LR, London, UK. FAU - Boeckl, O AU - Boeckl O FAU - Boneu, B AU - Boneu B FAU - Bordenave, L AU - Bordenave L FAU - Brehm, O A AU - Brehm OA FAU - Brucke, P AU - Brucke P FAU - Coccheri, S AU - Coccheri S FAU - Cohen, A T AU - Cohen AT FAU - Galland, F AU - Galland F FAU - Haas, S AU - Haas S FAU - Jarrige, J AU - Jarrige J FAU - Koppenhagen, K AU - Koppenhagen K FAU - LeQuerrec, A AU - LeQuerrec A FAU - Parraguette, E AU - Parraguette E FAU - Prandoni, P AU - Prandoni P FAU - Roder, J D AU - Roder JD FAU - Roos, M AU - Roos M FAU - Ruschemeyer, C AU - Ruschemeyer C FAU - Siewert, J R AU - Siewert JR FAU - Vinazzer, H AU - Vinazzer H FAU - Wenzel, E AU - Wenzel E LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - World J Surg JT - World journal of surgery JID - 7704052 RN - 0 (Anticoagulants) RN - 0 (Heparin, Low-Molecular-Weight) RN - 5R0L1D739E (reviparin) RN - 9005-49-6 (Heparin) SB - IM MH - Adult MH - Aged MH - Anticoagulants/*therapeutic use MH - Double-Blind Method MH - Female MH - Hemorrhage/chemically induced MH - Heparin/adverse effects/*therapeutic use MH - Heparin, Low-Molecular-Weight/adverse effects/*therapeutic use MH - Humans MH - Incidence MH - Male MH - Middle Aged MH - Postoperative Complications/mortality/*prevention & control MH - Pulmonary Embolism/mortality/prevention & control MH - Risk Factors MH - Thromboembolism/*prevention & control MH - Thrombophlebitis/epidemiology/prevention & control MH - Treatment Outcome EDAT- 1997/01/01 00:00 MHDA- 1997/01/01 00:01 CRDT- 1997/01/01 00:00 PHST- 1997/01/01 00:00 [pubmed] PHST- 1997/01/01 00:01 [medline] PHST- 1997/01/01 00:00 [entrez] AID - 10.1007/s002689900185 [doi] PST - ppublish SO - World J Surg. 1997 Jan;21(1):2-8; discussion 8-9. doi: 10.1007/s002689900185.