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

Condition(s) targeted: Venous Thromboembolism

Intervention: Sodium enoxaparin (Drug); Sodium Enoxaparin clexane (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Cristália Produtos Químicos Farmacêuticos Ltda.

Official(s) and/or principal investigator(s):
Gilson R de Araujo, PhD, Principal Investigator, Affiliation: Hospital Regional da Asa Norte

Overall contact:
Gilson R de Araujo, PhD, Phone: 61 3322 1044, Email: gilson.r.araujo@uol.com.br

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Evaluation of Sodium enoxaparin to demonstrate non-inferiority

Secondary outcome:

Safety of sodium enoxaparine

Compare the incidence of venous thromboembolism and pulmonar embolism

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Gilson R de Araujo, PhD, Phone: 61 3322 1044, Email: gilson.r.araujo@uol.com.br

Hospital Regional de Sobradinho, Brasilia, DF, Brazil; Not yet recruiting
Ricardo Andre V. Barros, PhD, Phone: 61 3248 2316, Email: ravba@uol.com.br
Maria Augusta R. Piazza, Biomedical, Phone: 11 5904 4458, Email: mariaaugusta@newcotrial.com
Ricardo Andre V. Barros, PhD, Principal Investigator

Hospital Regional da Asa Norte, Brasília, DF, Brazil; Not yet recruiting
Gilson R de Araujo, Phd, Phone: 61 3322-1044, Email: gilson.r.araujo@uol.com.br
Gilson R de Araujo, Phd, Principal Investigator

Starting date: May 2011
Last updated: March 2, 2011