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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01308528
First Posted: March 4, 2011
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cristália Produtos Químicos Farmacêuticos Ltda.
  Purpose
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.

Condition Intervention Phase
Venous Thromboembolism Drug: Sodium enoxaparin Drug: Sodium Enoxaparin clexane Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cristália Produtos Químicos Farmacêuticos Ltda.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.

  • 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


Enrollment: 243
Actual Study Start Date: February 2015
Study Completion Date: April 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium enoxaparin
Endocris - 40 mg/0,4mL
Drug: Sodium enoxaparin
40 mg/mL
Other Name: Endocris
Experimental: sodium enoxaparin Clexane
Clexane - 40 mg/ 0,4mL
Drug: Sodium Enoxaparin clexane
clexane 40 mg/ 0,4 mL
Other Name: clexane

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT01308528


Locations
Brazil
Hospital Regional da Asa Norte
Brasília, DF, Brazil
Huning Instituto de Oftalmologia e Pesquisa HIOP/HRPC
Canoas, Rio Grande do Sul, Brazil, 92425-900
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Fundação de Desenvolvimento da Unicamp - FUNCAMP
Campinas, São Paulo, Brazil, 13083-970
Hospital das Clínicas de Riberião Preto
Ribeirão Preto, São Paulo, Brazil, 14015-130
Hospital Estadual Mario Covas
Santo Andre, São Paulo, Brazil, 09190615
Centro Multidisciplinar de Estudos Clínicos
Sao Bernardo do Campo, São Paulo, Brazil, 09780000
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São Jósé do Rio Preto, São Paulo, Brazil, 15090-000
Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
Investigators
Principal Investigator: Gilson R de Araujo, PhD Hospital Regional da Asa Norte
  More Information

Responsible Party: Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier: NCT01308528     History of Changes
Other Study ID Numbers: CRT062
First Submitted: March 1, 2011
First Posted: March 4, 2011
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
Venous Thromboembolism

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