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

October 26, 2010 updated by: Azidus Brasil

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Valinhos, SP, Brazil, 13270000
        • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non-appearance of venous thromboembolism
Time Frame: 2 h before the start of surgery, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 days
2 h before the start of surgery, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azidus Brasil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

July 6, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

October 27, 2010

Last Update Submitted That Met QC Criteria

October 26, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPHIP0509_PRO
  • Version 01 - AMENDMENT 01
  • JAN. 2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Venous Thromboembolism

Clinical Trials on heparin sodium - Hipolabor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe