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

Study Overview
=================
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.

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.

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Biological: heparin sodium - Hipolabor
* Biological: Heparin sodium - APP


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |