Efficacy of Sodium Heparin in Prophylaxis of Venous Thromboembolism in Surgical Patients
The Venous thromboembolism (VTE) disease is very frequent, mainly as complications of medical diseases and surgical procedures. It has high prevalence and can lead to severe complications such as pulmonary embolism and postthrombotic syndrome. Although its incidence has been decreasing in recent years, the EP and DVT is still a major public health problem, especially in advanced age.
The tracking of this disease through imaging tests in asymptomatic patients does not seem to be a cost-effective, further treatment of complications is expensive and subject to no satisfactory answers are not completely effective in regard to late complications. Therefore, according CAIAFA & BASTOS (2002), effective prophylaxis is the best strategy.
The type of prevention to be used should be based on the risk of developing VTE, ie low, medium or high. Framework for a category of risk for the indication of prophylaxis, each patient should be evaluated individually and carefully to the risk of developing VTE. Maffei et al. (2005) describe the "Standards for Clinical Guideline for the prevention, diagnosis and treatment of deep vein thrombosis." According to the guide, the concentration of heparin in 5.000UI is indicated for cases of moderate-risk surgeries. Are classified as "moderate risk" to more surgery (general, gynecological and urological) in patients 40 to 60 years without additional risk factors, and the magnitude of any surgery in patients under 40 years of age who use estrogen ( Annex 01). The dosing schedule chosen in this study also follows the recommendation of the guide and is universally used .
According to Maffei et al. (2005), the diagnosis of VTE must be initiated by the history and physical examination, and then must be performed ultrasound Doppler of lower limbs. Thus, the ultra-sonography/doppler examination will be done at the beginning and end of treatment and physical examination will be done periodically throughout the period of monitoring.
Following the guidelines proposed by the literature consulted, was established to test this methodology, which aims to demonstrate the non inferiority clinical heparin sodium 5.000UI / 0.25 mL sodium heparin on 5.000UI / 1.0 mL, both produced by Blausiegel Industry and Trade Ltda. in reducing the incidence of VTE. The two formulations are produced from the same material, but have different drug concentrations. Thus, there is a need to scientifically prove that the therapeutic activity and safety of the product test is non-inferior to the comparator drug (APP heparina - 5.000 USP/mL), allowing the sponsoring company to obtain the registration of the product in the concentration of 5000UI /0.25 mL in ANVISA at the proposed therapeutic indication in the study.
|Venous Thromboembolism||Biological: heparin sodium - Blausiegel Biological: Heparin sodium - APP||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Efficacy of Sodium Heparin 5.000 UI/0.25 mL (Blausiegel) Compared With Heparin Sodium 5.000 USP (APP Pharmaceuticals)for Venous Thromboembolism Prophylaxis In Surgical Patients With Medium Risk For The Thromboembolism Development|
- Incidence of venous thromboembolism during the 28 days of study [ Time Frame: 2h before the start of surgery; 1 d. after 1st administration; 3 days; 5 days; 7 days; 14 days; 21 days; 28 days ]
- Incidence of adverse reactions during the treatment period [ Time Frame: 1 d. after 1st administration; 3 days; 5 days; 7 days; 14 days; 21 days; 28 days ]
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||January 2011|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Heparin Sodium 5.000UI/0.25mL
Biological: heparin sodium - Blausiegel
Heparin sodium - 5.000UI/0.25mL, twice a day for 7 days and 2 hours before the surgery
Active Comparator: Ative comparator
Heparin Sodium 5.000USP/mL
Biological: Heparin sodium - APP
Heparin sodium - 5.000USP/mL, twice a day for 7 days and 2 hours before the surgery