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

Cristalia

Status and phase

Completed

Phase 3

Conditions

Venous Thromboembolism

Treatments

Drug: Sodium enoxaparin

Drug: Sodium Enoxaparin clexane

Study type

Interventional

Funder types

Industry

Identifiers

NCT01308528

CRT062

Details and patient eligibility

About

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.

Full description

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

Enrollment

243 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.