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

NON CLINICAL INFERIORITY OF HEPARIN SODIUM PRODUCED BY HIPOLABOR FARMACEUTICA LTDA COMPARED TO THE HEPARIN SODIUM PRODUCED BY APP PHARMACEUTICALS IN VENOUS THROMBOEMBOLISM PROPHYLAXIS, IN SURGICAL PATIENTS WITH MEDIUM RISK FOR DEVELOPMENT OF THROMBOEMBOLISM.

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.

Study Overview

• Status: Unknown
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Biological: heparin sodium - Hipolabor; Biological: Heparin sodium - APP

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Valinhos, SP, Brazil, 13270000
      • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Hipolabor	Biological: heparin sodium - Hipolabor; 5.000 UI/0,25mL
Active Comparator: Comparator; 5.000 USP/mL - APP	Biological: Heparin sodium - APP; 5.000 USP/mL

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): November 1, 2010
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: July 6, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Estimate): October 27, 2010
• Last Update Submitted That Met QC Criteria: October 26, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: HEPHIP0509_PRO; Version 01 - AMENDMENT 01; JAN. 2010