Venous ThromboembolismPhase 2/3NCT00934167
Efficacy of Sodium Heparin for Prophylaxis of Venous Thromboembolism in Surgical Patients
A Phase 2/3 study testing heparin sodium - Hipolabor and Heparin sodium - APP in people with Venous Thromboembolism, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The aim of this study is to verify, through clinical examination and doppler, the non-inferiority of the drug test (heparin sodium 5.000UI/0.25 mL - HIPOLABOR) in relation to the drug compared (heparin sodium 5.000USP/mL - APP) in preventing the development of venous thromboembolism (VTE) in patients undergoing… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- heparin sodium - Hipolabor and Heparin sodium - APP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- May 2010to Sep 2011
- Phase
- Phase 2/3
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Accept all items described in IC signing it in two ways;
- Be aged between 18 and 60;
- Be alert to the need for surgery antithrombotic prophylaxis;
- Be classified as "moderate risk" for developing VTE, according to the protocol of prophylaxis of deep vein thrombosis of the Brazilian Society of Angiology and Vascular Surgery.
Who cannot join
- Acute coronary syndrome, it will make use of anticoagulation;
- Immobilization of the lower limbs due to fractures, because in this way will be considered as high risk;
- History of recent stroke;
- Patients at high risk of bleeding in which the use of heparin is contra-indicated;
- General Surgery in patients over 60 years in the case of patients at high risk for VTE;
- general surgery in patients 40 to 60 years with additional risk factors for development of VTE;
Show all 14Show fewer
- Major amputations;
- More orthopedic surgeries;
- Patients with pre-surgical diagnosis of malignant neoplasms;
- Patients with a platelet level below 100x109 / L;
- Use of anticoagulants 48 hours before randomization;
- Severe liver failure;
- Be classified as "Low Risk" or "high risk" for developing VTE, according to Maffei et al. (2005);
- Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, 13270000
About this study
Official title: NON CLINICAL INFERIORITY OF HEPARIN SODIUM PRODUCED BY HIPOLABOR FARMACEUTICA LTDA COMPARED TO THE HEPARIN SODIUM PRODUCED BY APP PHARMACEUTICALS IN VENOUS THROMBOEMBOLISM PROPHYLAXIS, IN SURGICAL PATIENTS WITH MEDIUM RISK FOR DEVELOPMENT OF THROMBOEMBOLISM.
The aim of this study is to verify, through clinical examination and doppler, the non-inferiority of the drug test (heparin sodium 5.000UI/0.25 mL - HIPOLABOR) in relation to the drug compared (heparin sodium 5.000USP/mL - APP) in preventing the development of venous thromboembolism (VTE) in patients undergoing surgery for medium risk for the development of this pathology.
- Conditions
- Venous Thromboembolism
- Being tested
- heparin sodium - Hipolabor, Heparin sodium - APP
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparin sodium - HipolaborBiological
5.000 UI/0,25mL
Heparin sodium - APPBiological
5.000 USP/mL
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Hipolabor Receives: Biological: heparin sodium - Hipolabor |
| Comparator | Active comparator | 5.000 USP/mL - APP Receives: Biological: Heparin sodium - APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-appearance of venous thromboembolism
Measured: 2 h before the start of surgery, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startMay 2010
- Primary completionNov 2010 (estimated)
- Study completionSep 2011 (estimated)
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934167
- Sponsor's protocol ID
- HEPHIP0509_PRO
- Other IDs
- Version 01 - AMENDMENT 01, JAN. 2010
- Status last verified
- Feb 2010
- First submitted
- 6 Jul 2009
- Last updated
- 27 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NON CLINICAL INFERIORITY OF HEPARIN SODIUM PRODUCED BY HIPOLABOR FARMACEUTICA LTDA COMPARED TO THE HEPARIN SODIUM PRODUCED BY APP PHARMACEUTICALS IN VENOUS THROMBOEMBOLISM PROPHYLAXIS, IN SURGICAL PATIENTS WITH MEDIUM RISK FOR DEVELOPMENT OF THROMBOEMBOLISM.
- ClinicalTrials.gov ID
- NCT00934167
- Acronym / sponsor ID
- HEPHIP0509_PRO
- Conditions
- Venous Thromboembolism
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 8 Jul 2009 (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 aim of this study is to verify, through clinical examination and doppler, the non-inferiority of the drug test (heparin sodium 5.000UI/0.25 mL - HIPOLABOR) in relation to the drug compared (heparin sodium 5.000USP/mL - APP) in preventing the development of venous thromboembolism (VTE) in patients undergoing surgery for medium risk for the development of this pathology.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Biological: heparin sodium - HipolaborHipolabor |
| Comparator | Active comparator | Biological: Heparin sodium - APP5.000 USP/mL - APP |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Accept all items described in IC signing it in two ways;
- Be aged between 18 and 60;
- Be alert to the need for surgery antithrombotic prophylaxis;
- Be classified as "moderate risk" for developing VTE, according to the protocol of prophylaxis of deep vein thrombosis of the Brazilian Society of Angiology and Vascular Surgery.
Key exclusion criteria (14 listed)
- Acute coronary syndrome, it will make use of anticoagulation;
- Immobilization of the lower limbs due to fractures, because in this way will be considered as high risk;
- History of recent stroke;
- Patients at high risk of bleeding in which the use of heparin is contra-indicated;
- General Surgery in patients over 60 years in the case of patients at high risk for VTE;
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 |
|---|---|---|
| heparin sodium - Hipolabor5.000 UI/0,25mL | Biological | Test |
| Heparin sodium - APP5.000 USP/mL | Biological | Comparator |
Primary outcome
Non-appearance of venous thromboembolism
Time frame: 2 h before the start of surgery, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing heparin sodium - Hipolabor and Heparin sodium - APP in people with Venous Thromboembolism, run by Azidus Brasil at 1 site 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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 27 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
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?
Non-appearance of venous thromboembolism (time frame: 2 h before the start of surgery, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 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 27 Oct 2010.