PMID- 8180325 OWN - NLM STAT- MEDLINE DCOM- 19940615 LR - 20171116 IS - 0957-5235 (Print) IS - 0957-5235 (Linking) VI - 4 Suppl 1 DP - 1993 Dec TI - An international multicentre study: Clivarin in the prevention of venous thromboembolism in patients undergoing general surgery. Report of the International Clivarin Assessment Group. PG - S21-2 AB - A randomized multicentre double-blind study was organized to evaluate the efficacy and the safety of Clivarin (reviparin-sodium) (anti-Xa/anti-IIa ratio: 3-5 International units) for the prevention of post-operative thromboembolism in patients undergoing general surgery. 1,351 patients were randomly allocated to receive subcutaneously either 5,000 U of unfractionated heparin (UFH) twice a day or 1,750 anti-Xa IU of reviparin-sodium once a day (morning) followed by a placebo injection (evening) for at least 6 days. Deep vein thrombosis (DVT) was detected with the 125I-fibrinogen technique confirmed by phlebography if necessary. After randomization thrombotic risk factors were equally distributed in each group. More than 50% of the patients had a cancer. The incidence of DVT and of pulmonary embolism was 4.8% (CI 95%: 3.3-6.7%) in the reviparin-sodium group and 4.4% (CI 95%: 2.9-6.2%) in the UFH group, a non-significant difference. The number of transfusions required was equivalent in the two groups. However, post-operative bleeding complications, including wound haematomas and internal bleeding, were less frequent in the reviparin-sodium group (P < 0.01). Therefore, for the first time, this study demonstrates that an unusual low dose of a low molecular weight heparin retains its antithrombotic efficacy by comparison with UFH and that the tolerance of this low dose is better. FAU - Boneu, B AU - Boneu B AD - Laboratoire d'Hemostase, C.H.R. Toulouse, Hopital Purpan, France. LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - England TA - Blood Coagul Fibrinolysis JT - Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis JID - 9102551 RN - 0 (Heparin, Low-Molecular-Weight) RN - 5R0L1D739E (reviparin) SB - IM MH - Adult MH - Aged MH - Double-Blind Method MH - Female MH - Hemorrhage/chemically induced MH - Heparin, Low-Molecular-Weight/adverse effects/therapeutic use MH - Humans MH - Incidence MH - Male MH - Middle Aged MH - Postoperative Complications/epidemiology/*prevention & control MH - Pulmonary Embolism/epidemiology/*prevention & control MH - Risk Factors MH - Thrombophlebitis/epidemiology/*prevention & control MH - Treatment Outcome EDAT- 1993/12/01 00:00 MHDA- 1993/12/01 00:01 CRDT- 1993/12/01 00:00 PHST- 1993/12/01 00:00 [pubmed] PHST- 1993/12/01 00:01 [medline] PHST- 1993/12/01 00:00 [entrez] PST - ppublish SO - Blood Coagul Fibrinolysis. 1993 Dec;4 Suppl 1:S21-2.