title: High vs. low doses of low-molecular-weight heparin for the treatment of superficial vein thrombosis of the legs: a double-blind, randomized trial.
abstract: In contrast with extensive information on the management of deep vein thrombosis of the lower extremities, little is known on the most appropriate treatment of the superficial vein thrombosis (SVT). In a multicenter, prospective, controlled, double-blind, double-dummy clinical trial, 164 consecutive patients with acute SVT of the great saphenous vein were randomized to receive the s.c. administration of either fixed prophylactic doses (2850 a-Xa IU) or body-weight adjusted therapeutic doses of nadroparin once daily for 1 month. The main study outcome was to compare the rate of asymptomatic and symptomatic extension of SVT and/or venous thromboembolic (VTE) complications during a 3-month follow-up period. Of the 81 patients randomized to the prophylactic doses, seven [8.6%; 95% confidence interval (CI), 3.5-17.0] developed SVT progression or VTE complications as compared with six of the 83 (7.2%; 95% CI, 2.8-15.1) allocated to the treatment group (absolute difference, 1.4; 96% CI, -6.9 to 9.7; P = 0.74). No patient in either group developed major bleeding. Our findings suggest that therapeutic doses of low-molecular-weight heparin, administered for 1 month in patients with SVT of the greater saphenous vein do not improve results obtained by prophylactic doses, administered for the same period, over a 3-month follow-up period.
authors.affiliation: Department of Medical and Surgical Sciences, University of Padova, Italy. paoloprandoni@tin.it
authors.forename: P
authors.initials: P
authors.lastname: Prandoni
authors.forename: D
authors.initials: D
authors.lastname: Tormene
authors.forename: R
authors.initials: R
authors.lastname: Pesavento
mesh_terms: D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage*; D006801:Humans; D015994:Incidence; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D011292:Premedication; D012501:Saphenous Vein; D013923:Thromboembolism / Q000517:prevention & control; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000150:complications / Q000188:drug therapy*
chemical_list: D006495:Heparin, Low-Molecular-Weight