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

NCT ID: NCT00934167

Last Updated: 2010-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Test

Hipolabor

Group Type EXPERIMENTAL

heparin sodium - Hipolabor

Intervention Type BIOLOGICAL

5.000 UI/0,25mL

Comparator

5.000 USP/mL - APP

Group Type ACTIVE_COMPARATOR

Heparin sodium - APP

Intervention Type BIOLOGICAL

5.000 USP/mL

Interventions

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heparin sodium - Hipolabor

5.000 UI/0,25mL

Intervention Type BIOLOGICAL

Heparin sodium - APP

5.000 USP/mL

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azidus Brasil

INDUSTRY

Sponsor Role lead

Responsible Party

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LAL Clinica Pesquisa e Desenvolvimento Ltda

Locations

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Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Version 01 - AMENDMENT 01

Identifier Type: -

Identifier Source: secondary_id

JAN. 2010

Identifier Type: -

Identifier Source: secondary_id

HEPHIP0509_PRO

Identifier Type: -

Identifier Source: org_study_id