NCT00362947

Different Doses and Duration of Low Molecular Weight Heparin (Parnaparin)in Superficial Vein Thrombosis

Randomized Clinical Study of Different Treatment Doses and Duration of Low Molecular Weight Heparin (Parnaparin) in Superficial Vein Thrombosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 664 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The optimal treatment of superficial venous thrombosis (SVT) is still uncertain. Though low molecular weight heparin (LMWH) is considered the treatment of choice, studies conducted so far do not give clear indications of the optimal dose and duration of treatment. This study aims to evaluate whether an intermediate therapeutic dose of LMWH (parnaparin) is more effective than a prophylactic dose and also to assess whether 10 rather than 30 days are sufficient for treatment.

Detailed description

Outpatients with an episode of SVT of the grand saphenous vein (for at least 4 cm), and/or SVT of the small saphenous vein (for at least 4 cm), and/or SVT of a collateral vein of the large saphenous vein of the thigh (for at least 4cm) are included in this prospective, randomised, double blind, national multicentre study. Patients will be randomised into double-blind groups to receive (syringes will be identical in appearance) in consecutively numbered boxes: A - Parnaparin, dose of 8,500 IU aXa taken subcutaneously once a day for 10 days B - Parnaparin, dose of 8,500 IU aXa per day for 10 days followed by Parnaparin 6,400 IU aXa per day for the subsequent three weeks. C - Parnaparin, dose of 4,250 IU aXa per day for 30 days Elastic compression treatment will be recommended with special stocking and/or elastic bandaging with compression to the ankles of 20-40 mmHg, where not contraindicated.

Conditions

• Thrombophlebitis

Interventions

Type	Name	Description
DRUG	LMWH parnaparin subcutaneously

Timeline

• Start date: 2006-08-01
• Primary completion: 2010-09-01
• Completion: 2011-02-01
• First posted: 2006-08-15
• Last updated: 2021-03-19

Locations

2 sites across 1 country: Italy