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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2015 by Cristália Produtos Químicos Farmacêuticos Ltda.
Sponsor:
Information provided by (Responsible Party):
Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:
NCT01308528
First received: March 1, 2011
Last updated: February 3, 2015
Last verified: February 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Compare the incidence of venous thromboembolism and pulmonar embolism between 2 groups after 30 days of surgery


Estimated Enrollment: 200
Study Start Date: February 2015
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308528

Contacts
Contact: Gilson R de Araujo, PhD 61 3322 1044 gilson.r.araujo@uol.com.br
Contact: Vanessa R Assao, Farmacêutica 11 372306400 vanessa.assao@cristalia.com.br

Locations
Brazil
Hospital Regional da Asa Norte Not yet recruiting
Brasília, DF, Brazil
Contact: Gilson R de Araujo, Phd    61 3322-1044    gilson.r.araujo@uol.com.br   
Principal Investigator: Gilson R de Araujo, Phd         
Huning Instituto de Oftalmologia e Pesquisa HIOP/HRPC Not yet recruiting
Canoas, Rio Grande do Sul, Brazil, 92425-900
Contact: Guido R Rosito, PhD         
Principal Investigator: Guido R Rosito, PhD         
Hospital São Lucas da PUCRS Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Contact: Salvador R Neto, PhD         
Principal Investigator: Salvador R Neto, PhF         
Hospital de Clínicas de Porto Alegre Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Alessandro R Osvaldt, PhD         
Principal Investigator: Alessandro R Osvaldt, PhD         
Fundação de Desenvolvimento da Unicamp - FUNCAMP
Campinas, São Paulo, Brazil, 13083-970
Hospital das Clínicas de Riberião Preto Not yet recruiting
Ribeirão Preto, São Paulo, Brazil, 14015-130
Contact: Sandro R Scarpelini, PhD         
Principal Investigator: Sandro R Scarpelini, PhD         
Hospital Estadual Mario Covas Not yet recruiting
Santo Andre, São Paulo, Brazil, 09190615
Contact: Agenor Jose R Costa, PhD         
Principal Investigator: Agenor Jose R Costa, PhD         
Centro Multidisciplinar de Estudos Clínicos Not yet recruiting
Sao Bernardo do Campo, São Paulo, Brazil, 09780000
Contact: João Antonio R Correa, PhD         
Principal Investigator: João Antonio R Correa, PhD         
Fundação Faculdade Regional de Medicina de São José do Rio Preto Not yet recruiting
São Jósé do Rio Preto, São Paulo, Brazil, 15090-000
Contact: Selma Regina R Raymundo, PhD         
Principal Investigator: Selma Regina R Raymundo, PhD         
Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
Investigators
Principal Investigator: Gilson R de Araujo, PhD Hospital Regional da Asa Norte
  More Information

No publications provided

Responsible Party: Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier: NCT01308528     History of Changes
Other Study ID Numbers: CRT062
Study First Received: March 1, 2011
Last Updated: February 3, 2015
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

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

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on May 29, 2015