Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Cristália Produtos Químicos Farmacêuticos Ltda..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Cristália Produtos Químicos Farmacêuticos Ltda.
Collaborators:
Hospital Regional da Asa Norte
Hospital Regional de Sobradinho
Information provided by:
Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:
NCT01308528
First received: March 1, 2011
Last updated: March 2, 2011
Last verified: June 2010
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Purpose
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.
| 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:
MedlinePlus related topics:
Deep Vein Thrombosis
Drug Information available for:
Enoxaparin sodium
U.S. FDA Resources
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: | 180 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | October 2012 (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
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: Maria Augusta R Piazza, Biomedical | 11 5904 4458 | mariaaugusta@newcotrials.com |
Locations
| Brazil | |
| Hospital Regional de Sobradinho | Not yet recruiting |
| Brasilia, DF, Brazil | |
| Contact: Ricardo Andre V. Barros, PhD 61 3248 2316 ravba@uol.com.br | |
| Contact: Maria Augusta R. Piazza, Biomedical 11 5904 4458 mariaaugusta@newcotrial.com | |
| Principal Investigator: Ricardo Andre V. Barros, PhD | |
| 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 | |
Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
Hospital Regional da Asa Norte
Hospital Regional de Sobradinho
Investigators
| Principal Investigator: | Gilson R de Araujo, PhD | Hospital Regional da Asa Norte |
More Information
No publications provided
| Responsible Party: | Jorge Barros Afiune, Cristalia Produtos Quimicos Farmaceuticos Ltda |
| ClinicalTrials.gov Identifier: | NCT01308528 History of Changes |
| Other Study ID Numbers: | CRT062 |
| Study First Received: | March 1, 2011 |
| Last Updated: | March 2, 2011 |
| 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 Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Enoxaparin |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 17, 2013