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

Venous Thromboembolism Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00934167
• Other study ID #: HEPHIP0509_PRO
• Secondary ID: Version 01 - AME
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: July 6, 2009
• Last updated: October 26, 2010
• Start date: May 2010
• Est. completion date: September 2011

Study information

• Verified date: February 2010
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: September 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Biological:
• heparin sodium - Hipolabor
5.000 UI/0,25mL
• Heparin sodium - APP
5.000 USP/mL

Locations

Country	Name	City	State
Brazil	Lal Clinica Pesquisa E Desenvolvimento Ltda	Valinhos	SP

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-appearance of venous thromboembolism		2 h before the start of surgery, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 days	No