NCT00711308

Tinzaparin in the Treatment of the Acute Pulmonary Embolism

Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants in the Treatment of the Acute Pulmonary Embolism

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Complejo Hospitalario Xeral-Calde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the feasibility of the long-term treatment of pulmonary embolism with tinzaparin compared to oral anticoagulants.

Detailed description

The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin) administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for 6 months in patients with acute venous thrombosis. To evaluate the direct and indirect cost of each treatment regimen in a rural population environment.

Conditions

• Acute Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	tinzaparin	tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
DRUG	acenocoumarol	acenocoumarol for 6 months

Timeline

• Start date: 2005-04-01
• Primary completion: 2009-01-01
• Completion: 2009-02-01
• First posted: 2008-07-08
• Last updated: 2009-02-13

Locations

4 sites across 1 country: Spain