NCT01308528

Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery

A Non-Inferiority Study of Enoxaparin Cristalia in Relation With Enoxaparin Sanofi-Aventis for Prophylaxis Against Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and security and efficacy of sodium enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endocris with Clexane (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery.

Detailed description

This study is a requirement of Anvisa to add a new indication for off-label drug

Conditions

• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Sodium enoxaparin	40 mg/mL
DRUG	Sodium Enoxaparin clexane	clexane 40 mg/ 0,4 mL

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-02-01
• Completion: 2017-04-01
• First posted: 2011-03-04
• Last updated: 2017-07-19

Locations

9 sites across 1 country: Brazil