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 April 2014 by Cristália Produtos Químicos Farmacêuticos Ltda.
Sponsor:
Collaborators:
HRAN - Hospital Regional da Asa Norte
HRS - Hospital Regional de Sobradinho
Information provided by (Responsible Party):
Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:
NCT01308528
First received: March 1, 2011
Last updated: April 1, 2014
Last verified: April 2014

March 1, 2011
April 1, 2014
July 2014
August 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01308528 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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 - Endorcris with Clexane (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Venous Thromboembolism
  • Drug: Sodium enoxaparin
    40 mg/mL
    Other Name: Endocris
  • Drug: Sodium Enoxaparin clexane
    clexane 40 mg/ 0,4 mL
    Other Name: clexane
  • Experimental: Sodium enoxaparin
    Endocris - 40 mg/0,4mL
    Intervention: Drug: Sodium enoxaparin
  • Experimental: sodium enoxaparin Clexane
    Clexane - 40 mg/ 0,4mL
    Intervention: Drug: Sodium Enoxaparin clexane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
180
August 2015
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Gilson R de Araujo, PhD 61 3322 1044 gilson.r.araujo@uol.com.br
Contact: Maria Augusta R Piazza, Biomedical 11 5904 4458 mariaaugusta@newcotrials.com
Brazil
 
NCT01308528
CRT062
No
Cristália Produtos Químicos Farmacêuticos Ltda.
Cristália Produtos Químicos Farmacêuticos Ltda.
  • HRAN - Hospital Regional da Asa Norte
  • HRS - Hospital Regional de Sobradinho
Principal Investigator: Gilson R de Araujo, PhD Hospital Regional da Asa Norte
Cristália Produtos Químicos Farmacêuticos Ltda.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP