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Trial record 78 of 990 for:    Heparin sodium

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

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ClinicalTrials.gov Identifier: NCT00934167
Recruitment Status : Unknown
Verified February 2010 by Azidus Brasil.
Recruitment status was:  Active, not recruiting
First Posted : July 8, 2009
Last Update Posted : October 27, 2010
Sponsor:
Information provided by:
Azidus Brasil

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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Biological: heparin sodium - Hipolabor Biological: Heparin sodium - APP Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Study Start Date : May 2010
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934167


Locations
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Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
Azidus Brasil

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Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT00934167     History of Changes
Other Study ID Numbers: HEPHIP0509_PRO
Version 01 - AMENDMENT 01
JAN. 2010
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: October 27, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
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Heparin
Calcium heparin
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action