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.
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
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
- Conditions
- Venous Thromboembolism
- 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 group | Role | What they receive |
|---|---|---|
| Sodium enoxaparin | Experimental | Endocris - 40 mg/0,4mL Receives: Drug: Sodium enoxaparin |
| sodium enoxaparin Clexane | Experimental | Clexane - 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.
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)
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
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.
- First posted4 Mar 2011 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilson R de Araujo, PhD, Principal investigator, Hospital Regional da Asa Norte
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01308528
- Acronym / sponsor ID
- CRT062
- Conditions
- Venous Thromboembolism
- Keywords
- Venous Thromboembolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.Industry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium enoxaparin | Experimental | Drug: Sodium enoxaparinEndocris - 40 mg/0,4mL |
| sodium enoxaparin Clexane | Experimental | Drug: Sodium Enoxaparin clexaneClexane - 40 mg/ 0,4mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium enoxaparinAlso: Endocris40 mg/mL | Drug | Sodium enoxaparin |
| Sodium Enoxaparin clexaneAlso: clexaneclexane 40 mg/ 0,4 mL | Drug | sodium enoxaparin Clexane |
Primary outcome
Evaluation of Sodium enoxaparin to demonstrate non-inferiority
Time frame: 10 Days
Evaluation of Prophylactic use of Sodium enoxaparin to demonstrate non-inferiority for Venous Thromboembolism in High-Risk Surgery in Abdominal
2 secondary outcomes
Safety of sodium enoxaparine
Time frame: 10 days
Compare the incidence of venous thromboembolism and pulmonar embolism
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilson R de Araujo, PhD principal investigator
Hospital Regional da Asa Norte
9 sites in 1 country: see every site and its status.
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?
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.