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

Azidus

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Venous Thromboembolism

Treatments

Biological: Heparin sodium - APP

Biological: heparin sodium - Hipolabor

Study type

Interventional

Funder types

Industry

Identifiers

NCT00934167

JAN. 2010

Version 01 - AMENDMENT 01

HEPHIP0509_PRO

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.