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

NCT ID: NCT01308528

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-04-30

Brief Summary

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.

Detailed Description

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

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sodium enoxaparin

Endocris - 40 mg/0,4mL

Group Type: EXPERIMENTAL

Sodium enoxaparin

Intervention Type: DRUG

40 mg/mL

sodium enoxaparin Clexane

Clexane - 40 mg/ 0,4mL

Group Type: EXPERIMENTAL

Sodium Enoxaparin clexane

Intervention Type: DRUG

clexane 40 mg/ 0,4 mL

Interventions

Sodium enoxaparin

40 mg/mL

Intervention Type: DRUG

Sodium Enoxaparin clexane

clexane 40 mg/ 0,4 mL

Intervention Type: DRUG

Other Intervention Names

Endocris; clexane

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cristália Produtos Químicos Farmacêuticos Ltda.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilson R de Araujo, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Regional da Asa Norte

Locations

Hospital Regional da Asa Norte

Brasília, Federal District, Brazil

Huning Instituto de Oftalmologia e Pesquisa HIOP/HRPC

Canoas, Rio Grande do Sul, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Fundação de Desenvolvimento da Unicamp - FUNCAMP

Campinas, São Paulo, Brazil

Hospital das Clínicas de Riberião Preto

Ribeirão Preto, São Paulo, Brazil

Hospital Estadual Mario Covas

Santo André, São Paulo, Brazil

Centro Multidisciplinar de Estudos Clínicos

São Bernardo do Campo, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São Jósé Do Rio Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CRT062

Identifier Type: -

Identifier Source: org_study_id