Efficacy of Sodium Heparin for Prophylaxis of Venous Thromboembolism in Surgical Patients

Phase 2

• Conditions: Venous Thromboembolism
• Interventions: Biological: heparin sodium - Hipolabor; Biological: Heparin sodium - APP

• Registration Number: NCT00934167
• Lead Sponsor: Azidus Brasil

Brief Summary

The aim of this study is to verify, through clinical examination and doppler, the non-inferiority of the drug test (heparin sodium 5.000UI/0.25 mL - HIPOLABOR) in relation to the drug compared (heparin sodium 5.000USP/mL - APP) in preventing the development of venous thromboembolism (VTE) in patients undergoing surgery for medium risk for the development of this pathology.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-06
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Status Verified: 2010-02
• Study Start: 2010-05
• Last Update Submitted: 2010-10-26
• Last Update Posted: 2010-10-27
• Primary Completion: 2010-11
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Accept all items described in IC signing it in two ways;
• Be aged between 18 and 60;
• Be alert to the need for surgery antithrombotic prophylaxis;
• Be classified as "moderate risk" for developing VTE, according to the protocol of prophylaxis of deep vein thrombosis of the Brazilian Society of Angiology and Vascular Surgery.

Exclusion Criteria

• Acute coronary syndrome, it will make use of anticoagulation;
• Immobilization of the lower limbs due to fractures, because in this way will be considered as high risk;
• History of recent stroke;
• Patients at high risk of bleeding in which the use of heparin is contra-indicated;
• General Surgery in patients over 60 years in the case of patients at high risk for VTE;
• general surgery in patients 40 to 60 years with additional risk factors for development of VTE;
• Major amputations;
• More orthopedic surgeries;
• Patients with pre-surgical diagnosis of malignant neoplasms;
• Patients with a platelet level below 100x109 / L;
• Use of anticoagulants 48 hours before randomization;
• Severe liver failure;
• Be classified as "Low Risk" or "high risk" for developing VTE, according to Maffei et al. (2005);
• Pregnancy and lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	heparin sodium - Hipolabor	Hipolabor
Comparator	Heparin sodium - APP	5.000 USP/mL - APP

Primary Outcome Measures

Name	Time	Method
Non-appearance of venous thromboembolism	2 h before the start of surgery, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 days

Trial Locations

Locations (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda; 🇧🇷 Valinhos, SP, Brazil