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

Primary Purpose

Venous Thromboembolism

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
heparin sodium - Hipolabor
Heparin sodium - APP
Sponsored by
Azidus Brasil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Lal Clinica Pesquisa E Desenvolvimento Ltda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test

Comparator

Arm Description

Hipolabor

5.000 USP/mL - APP

Outcomes

Primary Outcome Measures

Non-appearance of venous thromboembolism

Secondary Outcome Measures

Full Information

First Posted
July 6, 2009
Last Updated
October 26, 2010
Sponsor
Azidus Brasil
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1. Study Identification

Unique Protocol Identification Number
NCT00934167
Brief Title
Efficacy of Sodium Heparin for Prophylaxis of Venous Thromboembolism in Surgical Patients
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 Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Azidus Brasil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
Hipolabor
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
5.000 USP/mL - APP
Intervention Type
Biological
Intervention Name(s)
heparin sodium - Hipolabor
Intervention Description
5.000 UI/0,25mL
Intervention Type
Biological
Intervention Name(s)
Heparin sodium - APP
Intervention Description
5.000 USP/mL
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Lal Clinica Pesquisa E Desenvolvimento Ltda
City
Valinhos
State/Province
SP
ZIP/Postal Code
13270000
Country
Brazil

12. IPD Sharing Statement

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

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