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

NCT00912483 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-03-29

No results posted yet for this study

Summary

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.

Conditions

  • Venous Thromboembolism

Interventions

BIOLOGICAL

heparin sodium - Blausiegel

Heparin sodium - 5.000UI/0.25mL, twice a day for 7 days and 2 hours before the surgery

BIOLOGICAL

Heparin sodium - APP

Heparin sodium - 5.000USP/mL, twice a day for 7 days and 2 hours before the surgery

Sponsors & Collaborators

  • Azidus Brasil

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-11-30
Completion
2011-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00912483 on ClinicalTrials.gov