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Venous ThromboembolismPhase 3NCT01308528

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

A Phase 3 study testing Sodium enoxaparin and Sodium Enoxaparin clexane in people with Venous Thromboembolism, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 9 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thromboembolism
What is being tested?
Sodium enoxaparin and Sodium Enoxaparin clexane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
243 participants
Where
9 sitesBrazil
Study dates
Feb 2015to Apr 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 32Show fewer
  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Brazil9 sites

  • Hospital Regional da Asa Norte

    Brasília, Federal District

  • Fundação de Desenvolvimento da Unicamp - FUNCAMP

    Campinas, São Paulo, 13083-970

  • Huning Instituto de Oftalmologia e Pesquisa HIOP/HRPC

    Canoas, Rio Grande do Sul, 92425-900

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital das Clínicas de Riberião Preto

    Ribeirão Preto, São Paulo, 14015-130

  • Hospital Estadual Mario Covas

    Santo André, São Paulo, 09190615

  • Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, São Paulo, 09780000

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

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

Other trials in Brazil

About this study

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

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.

Read the detailed description

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

Being tested
Sodium enoxaparin, Sodium Enoxaparin clexane
Keywords
Venous Thromboembolism
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium enoxaparinDrug

    Also called Endocris

    40 mg/mL

  • Sodium Enoxaparin clexaneDrug

    Also called clexane

    clexane 40 mg/ 0,4 mL

Study groups in NCT01308528
Study groupRoleWhat they receive
Sodium enoxaparinExperimentalEndocris - 40 mg/0,4mL
Receives: Drug: Sodium enoxaparin
sodium enoxaparin ClexaneExperimentalClexane - 40 mg/ 0,4mL
Receives: Drug: Sodium Enoxaparin clexane

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 10 Days

Secondary outcomes (2)

  1. Safety of sodium enoxaparine

    comparision between Endocris (sodium enoxaparin - Cristalia Prod. Quim. Farm.) versus Clexane (sodium enoxaparine - Sanofi-Aventis) in High-Risk Abdominal Surgery.

    Measured: 10 days

  2. Compare the incidence of venous thromboembolism and pulmonar embolism

    Compare the incidence of venous thromboembolism and pulmonar embolism between 2 groups after 30 days of surgery

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2011 (estimated)
  2. Study startFeb 2015
  3. Primary completionFeb 2017
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01308528
Sponsor's protocol ID
CRT062
Status last verified
Jul 2017
First submitted
1 Mar 2011
Last updated
19 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sodium enoxaparin and Sodium Enoxaparin clexane in people with Venous Thromboembolism, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 9 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Sodium enoxaparin to demonstrate non-inferiority (time frame: 10 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01308528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.

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