High versus low doses of unfractionated heparin for the treatment of superficial thrombophlebitis of the leg. A prospective, controlled, randomized study.
OBJECTIVE
The optimal treatment of superficial thrombophlebitis of the leg is undefined. The main study objective was to assess the efficacy and safety of unmonitored high doses as compared to low doses of unfractionated heparin (UFH) for prevention of venous thromboembolic complications in patients with superficial thrombophlebitis of the thigh.


METHODS
Sixty consecutive patients with acute thrombophlebitis of the great saphenous vein, as assessed by ultrasonography, were randomized to subcutaneous injection twice daily of UFH in high unmonitored doses (12,500 IU for one week followed by 10,000 IU) or prophylactic doses (5,000 IU) for four weeks. The rate of asymptomatic involvement of the deep venous system and/or symptomatic thromboembolic events during a six-month follow-up period was assessed and compared between the two study groups.


RESULTS
Six of the 30 patients (20.0 %; 95% CI, 7.7 to 38.6) randomized to low-dose UFH developed symptomatic or asymptomatic events as compared to 1 of the 30 patients (3.3%; 95% CI, 0.07 to 17.2) who received high-dose UFH (p=0.05 by one-sided Fisher's exact test). No patient experienced major bleeding complications in either group.


CONCLUSIONS
The results of this study suggest that in patients with acute thrombophlebitis of the thigh unmonitored high doses of UFH are more effective than prophylactic doses of UFH for prevention of venous thromboembolic complications and do not enhance the risk of bleeding complications.
Marchiori
Antonio
A
Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University Hospital of Padua, Italy.
Verlato
Fabio
F
Sabbion
Paola
P
Camporese
Giuseppe
G
Rosso
Federica
F
Mosena
Laura
L
Andreozzi
Giuseppe Maria
GM
Prandoni
Paolo
P
D004305:Dose-Response Relationship, Drug; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000008:administration & dosage* / Q000633:toxicity; D006801:Humans; D007866:Leg / Q000098:blood supply; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012501:Saphenous Vein / Q000000981:diagnostic imaging / Q000473:pathology; D013924:Thrombophlebitis / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome; D014463:Ultrasonography
D006493:Heparin