NCT01308528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
3.9 years until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

March 1, 2011

Last Update Submit

July 18, 2017

Conditions

Venous Thromboembolism

Keywords

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Sodium enoxaparin to demonstrate non-inferiority

    Evaluation of Prophylactic use of Sodium enoxaparin to demonstrate non-inferiority for Venous Thromboembolism in High-Risk Surgery in Abdominal

    10 Days

Secondary Outcomes (2)

  • Safety of sodium enoxaparine

    10 days

  • Compare the incidence of venous thromboembolism and pulmonar embolism

    10 days

Study Arms (2)

Sodium enoxaparin

EXPERIMENTAL

Endocris - 40 mg/0,4mL

Drug: Sodium enoxaparin

sodium enoxaparin Clexane

EXPERIMENTAL

Clexane - 40 mg/ 0,4mL

Drug: Sodium Enoxaparin clexane

Interventions

Sodium enoxaparinDRUG

40 mg/mL

Also known as: Endocris
Sodium enoxaparin
Sodium Enoxaparin clexaneDRUG

clexane 40 mg/ 0,4 mL

Also known as: clexane
sodium enoxaparin Clexane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hospital Regional da Asa Norte

Brasília, Federal District, Brazil

Location

Huning Instituto de Oftalmologia e Pesquisa HIOP/HRPC

Canoas, Rio Grande do Sul, 92425-900, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Fundação de Desenvolvimento da Unicamp - FUNCAMP

Campinas, São Paulo, 13083-970, Brazil

Location

Hospital das Clínicas de Riberião Preto

Ribeirão Preto, São Paulo, 14015-130, Brazil

Location

Hospital Estadual Mario Covas

Santo André, São Paulo, 09190615, Brazil

Location

Centro Multidisciplinar de Estudos Clínicos

São Bernardo do Campo, São Paulo, 09780000, Brazil

Location

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São Jósé Do Rio Preto, São Paulo, 15090-000, Brazil

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

enoxaparin sodiumEnoxaparin

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Gilson R de Araujo, PhD

    Hospital Regional da Asa Norte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 4, 2011

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

BR(9)