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: P Prandoni, D Tormene, R Pesavento, Vesalio Investigators Group
• Journal: Journal of thrombosis and haemostasis : JTH (J Thromb Haemost) Vol. 3 Issue 6 Pg. 1152-7 (Jun 2005) ISSN: 1538-7933 [Print] England
• PMID: 15946202 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Heparin, Low-Molecular-Weight

Topics

• Aged
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Heparin, Low-Molecular-Weight (administration & dosage)
• Humans
• Incidence
• Leg (blood supply)
• Male
• Middle Aged
• Premedication
• Saphenous Vein
• Thromboembolism (prevention & control)
• Treatment Outcome
• Venous Thrombosis (complications, drug therapy)