- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01308528
Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery
July 18, 2017 updated by: Cristália Produtos Químicos Farmacêuticos Ltda.
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
Status
Completed
Conditions
Intervention / Treatment
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:
|
Experimental: sodium enoxaparin Clexane
Clexane - 40 mg/ 0,4mL
|
clexane 40 mg/ 0,4 mL
Other Names:
|
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRT062
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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