Clinical trial NCT01308528: Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: Venous Thromboembolism
Lead sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
Sponsor class: INDUSTRY
First posted: 2011-03-04
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Evaluation of Sodium enoxaparin to demonstrate non-inferiority
timeFrame: 10 Days
Secondary outcomes:
measure: Safety of sodium enoxaparine
timeFrame: 10 days
measure: Compare the incidence of venous thromboembolism and pulmonar embolism
timeFrame: 10 days
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Hospital Regional da Asa Norte
state: DF
city: Canoas
country: Brazil
facility: Huning Instituto de Oftalmologia e Pesquisa HIOP/HRPC
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande do Sul
city: Campinas
country: Brazil
facility: Fundação de Desenvolvimento da Unicamp - FUNCAMP
state: São Paulo
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas de Riberião Preto
state: São Paulo
city: Santo Andre
country: Brazil
facility: Hospital Estadual Mario Covas
state: São Paulo
city: Sao Bernardo do Campo
country: Brazil
facility: Centro Multidisciplinar de Estudos Clínicos
state: São Paulo
city: São Jósé do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: São Paulo
Study officials:
affiliation: Hospital Regional da Asa Norte
name: Gilson R de Araujo, PhD
role: PRINCIPAL_INVESTIGATOR
References: