Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery

A Non-Inferiority Study of Enoxaparin Cristalia in Relation With Enoxaparin Sanofi-Aventis for Prophylaxis Against Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery

The purpose of this study is to compare the safety and security and efficacy of sodium enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endocris with Clexane (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery.

Study Overview

Detailed Description

This study is a requirement of Anvisa to add a new indication for off-label drug

Study Type

Interventional

Enrollment (Actual)

243

Phase

  • 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

    • DF
      • Brasília, DF, Brazil
        • Hospital Regional da Asa Norte
    • Rio Grande do Sul
      • Canoas, Rio Grande do Sul, Brazil, 92425-900
        • Huning Instituto de Oftalmologia e Pesquisa HIOP/HRPC
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital Sao Lucas da PUCRS
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-970
        • Fundação de Desenvolvimento da Unicamp - FUNCAMP
      • Ribeirão Preto, São Paulo, Brazil, 14015-130
        • Hospital das Clínicas de Riberião Preto
      • Santo Andre, São Paulo, Brazil, 09190615
        • Hospital Estadual Mario Covas
      • Sao Bernardo do Campo, São Paulo, Brazil, 09780000
        • Centro Multidisciplinar de Estudos Clinicos
      • São Jósé do Rio Preto, São Paulo, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged above 18 years undergoing abdominal surgery with general high risk for developing venous thromboembolism;
  • Who have provided their consent by signing the consent form.

Exclusion Criteria:

  • Clinical evidence of Venous thromboembolism (VTE) in the selection;
  • treatment requirement with anticoagulant Low Molecular Weight Heparin, Unfracted Heparin, oral anticoagulant
  • suspicion or history of coagulumpathia
  • Heparin, enoxaparin allergy or hypersensitiviy known to heparin, enoxaparin, but not restrict to thrombocytopenia and/or induce thombose by heparin ou enoxaparin (thrombocytopenia induce by heparin [TIH], thrombocytopenia associate with heparin [TAH] or thrombotic thrombocytopenia syndrome induce by heparin [STTIH]
  • Active bleeding that can be increased by enoxaparin.
  • Previous history of known intracranial hemorrhage
  • Artery-venous malformation or a suspicion or known cerebral aneurism
  • Spinal, Epidural ou lumbar puncture analgesia in the last 24 hours previous of the first dose of the administration of the enoxaparin.
  • erosive diseases of the digestive tract especially gastroduodenal
  • Uncontrolled hypertension (systolic blood pressure [BP]> 180mmHg or diastolic BP> 100 mm Hg) at randomization or clinical hypertensive urgency;
  • bacterial endocarditis
  • heart valve prosthesis
  • characterized by severe renal insufficiency creatinine clearance <30 ml / min
  • Intra-arterial thrombolic therapy
  • Thrombolic therapy within 24 hours.
  • Low Molecular Weight Heparin or Unfraction Heparin treatment with prophylactic dose over 48 hours before surgery or oral anticoagulant within 5 days before surgery
  • disturbance of consciousness and coma
  • Less than 6 months of expectative time life
  • Chemical dependency
  • Patient with anesthetic risk ASA III or ASA IV
  • morbid obesity with Body Mass Index ≥ 40
  • Chronic use of corticosteroids
  • History of allergy to Unfraction Heparin, Low molecular weight heparin or pork products.
  • History of severe allergic episode, systemic anaphylaxis, or major urticarial disease Steven-Johnson
  • Participation in another clinical study within 12 months prior to inclusion
  • Potentially fertile woman without β-HCG negative harvested until 48 hours before operation or not using acceptable contraception for participation in this study
  • Changes the security checks up to 48 h before randomization:

    • Hemoglobin <10 mg / dL;
    • ALT or AST ≥ 2.5 times ULN;
    • Platelet count <100.000/mL;
    • INR ≥ 1.5;
  • Any condition which in the opinion of the investigator, could lead to increased risk for the patient or who makes it inappropriate for this study.

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: Sodium enoxaparin
Endocris - 40 mg/0,4mL
40 mg/mL
Other Names:
  • Endocris
Experimental: sodium enoxaparin Clexane
Clexane - 40 mg/ 0,4mL
clexane 40 mg/ 0,4 mL
Other Names:
  • clexane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Sodium enoxaparin to demonstrate non-inferiority
Time Frame: 10 Days
Evaluation of Prophylactic use of Sodium enoxaparin to demonstrate non-inferiority for Venous Thromboembolism in High-Risk Surgery in Abdominal
10 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of sodium enoxaparine
Time Frame: 10 days
comparision between Endocris (sodium enoxaparin - Cristalia Prod. Quim. Farm.) versus Clexane (sodium enoxaparine - Sanofi-Aventis) in High-Risk Abdominal Surgery.
10 days
Compare the incidence of venous thromboembolism and pulmonar embolism
Time Frame: 10 days
Compare the incidence of venous thromboembolism and pulmonar embolism between 2 groups after 30 days of surgery
10 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Gilson R de Araujo, PhD, Hospital Regional da Asa Norte

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 (Actual)

February 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 2, 2011

First Posted (Estimate)

March 4, 2011

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

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.

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