Venous ThromboembolismPhase 3NCT00912483
Efficacy of Sodium Heparin in Prophylaxis of Venous Thromboembolism in Surgical Patients
A Phase 3 study testing heparin sodium - Blausiegel and Heparin sodium - APP in people with Venous Thromboembolism, run by Azidus Brasil.
Trial summary
The Venous thromboembolism (VTE) disease is very frequent, mainly as complications of medical diseases and surgical procedures. It has high prevalence and can lead to severe complications such as pulmonary embolism and postthrombotic syndrome. 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 - Blausiegel and Heparin sodium - APP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Jan 2011
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Accept all items described in Informed Consent, signing it in two ways;
- Age between 40 and 60 years without additional risk factors, which held more surgery (general, gynecological and urological);
- Women aged 18 to 40 years making use of estrogen;
- 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;
- 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
- Pregnancy and lactation.
About this study
Official title: Efficacy of Sodium Heparin 5.000 UI/0.25 mL (Blausiegel) Compared With Heparin Sodium 5.000 USP (APP Pharmaceuticals)for Venous Thromboembolism Prophylaxis In Surgical Patients With Medium Risk For The Thromboembolism Development
The Venous thromboembolism (VTE) disease is very frequent, mainly as complications of medical diseases and surgical procedures. It has high prevalence and can lead to severe complications such as pulmonary embolism and postthrombotic syndrome. Although its incidence has been decreasing in recent years, the EP and DVT is still a major public health problem, especially in advanced age.
The tracking of this disease through imaging tests in asymptomatic patients does not seem to be a cost-effective, further treatment of complications is expensive and subject to no satisfactory answers are not completely effective in regard to late complications. Therefore, according CAIAFA \& BASTOS (2002), effective prophylaxis is the best strategy.
Read more
The type of prevention to be used should be based on the risk of developing VTE, ie low, medium or high. Framework for a category of risk for the indication of prophylaxis, each patient should be evaluated individually and carefully to the risk of developing VTE. Maffei et al. (2005) describe the "Standards for Clinical Guideline for the prevention, diagnosis and treatment of deep vein thrombosis." According to the guide, the concentration of heparin in 5.000UI is indicated for cases of moderate-risk surgeries. Are classified as "moderate risk" to more surgery (general, gynecological and urological) in patients 40 to 60 years without additional risk factors, and the magnitude of any surgery in patients under 40 years of age who use estrogen ( Annex 01). The dosing schedule chosen in this study also follows the recommendation of the guide and is universally used .
According to Maffei et al. (2005), the diagnosis of VTE must be initiated by the history and physical examination, and then must be performed ultrasound Doppler of lower limbs. Thus, the ultra-sonography/doppler examination will be done at the beginning and end of treatment and physical examination will be done periodically throughout the period of monitoring.
Following the guidelines proposed by the literature consulted, was established to test this methodology, which aims to demonstrate the non inferiority clinical heparin sodium 5.000UI / 0.25 mL sodium heparin on 5.000UI / 1.0 mL, both produced by Blausiegel Industry and Trade Ltda. in reducing the incidence of VTE. The two formulations are produced from the same material, but have different drug concentrations. Thus, there is a need to scientifically prove that the therapeutic activity and safety of the product test is non-inferior to the comparator drug (APP heparina - 5.000 USP/mL), allowing the sponsoring company to obtain the registration of the product in the concentration of 5000UI /0.25 mL in ANVISA at the proposed therapeutic indication in the study.
- Conditions
- Venous Thromboembolism
- Being tested
- heparin sodium - Blausiegel, Heparin sodium - APP
- Keywords
- VTE
- 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 - BlausiegelBiological
Heparin sodium - 5.000UI/0.25mL, twice a day for 7 days and 2 hours before the surgery
Heparin sodium - APPBiological
Heparin sodium - 5.000USP/mL, twice a day for 7 days and 2 hours before the surgery
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Heparin Sodium 5.000UI/0.25mL Receives: Biological: heparin sodium - Blausiegel |
| Ative comparator | Active comparator | Heparin Sodium 5.000USP/mL Receives: Biological: Heparin sodium - APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of venous thromboembolism during the 28 days of study
Measured: 2h before the start of surgery; 1 d. after 1st administration; 3 days; 5 days; 7 days; 14 days; 21 days; 28 days
Secondary outcomes (1)
Incidence of adverse reactions during the treatment period
Measured: 1 d. after 1st administration; 3 days; 5 days; 7 days; 14 days; 21 days; 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMay 2010
- Primary completionNov 2010 (estimated)
- Study completionJan 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912483
- Sponsor's protocol ID
- HEPBLA0409
- Other IDs
- Thomboembolism, Heparin, Prophylaxis
- Status last verified
- Mar 2013
- First submitted
- 1 Jun 2009
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sodium Heparin 5.000 UI/0.25 mL (Blausiegel) Compared With Heparin Sodium 5.000 USP (APP Pharmaceuticals)for Venous Thromboembolism Prophylaxis In Surgical Patients With Medium Risk For The Thromboembolism Development
- ClinicalTrials.gov ID
- NCT00912483
- Acronym / sponsor ID
- HEPBLA0409
- Conditions
- Venous Thromboembolism
- Keywords
- VTE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 3 Jun 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 Venous thromboembolism (VTE) disease is very frequent, mainly as complications of medical diseases and surgical procedures. It has high prevalence and can lead to severe complications such as pulmonary embolism and postthrombotic syndrome. Although its incidence has been decreasing in recent years, the EP and DVT is still a major public health problem, especially in advanced age.
The tracking of this disease through imaging tests in asymptomatic patients does not seem to be a cost-effective, further treatment of complications is expensive and subject to no satisfactory answers are not completely effective in regard to late complications. Therefore, according CAIAFA \& BASTOS (2002), effective prophylaxis is the best strategy.
The type of prevention to be used should be based on the risk of developing VTE, ie low, medium or high. Framework for a category of risk for the indication of prophylaxis, each patient should be evaluated individually and carefully to the risk of developing VTE. Maffei et al. (2005) describe the "Standards for Clinical Guideline for the prevention, diagnosis and treatment of deep vein thrombosis." According to the guide, the concentration of heparin in 5.000UI is indicated for cases of moderate-risk surgeries. Are classified as "moderate risk" to more surgery (general, gynecological and urological) in patients 40 to 60 years without additional risk factors, and the magnitude of any surgery in patients under 40 years of age who use estrogen ( Annex 01). The dosing schedule chosen in this study also follows the recommendation of the guide and is universally used .
According to Maffei et al. (2005), the diagnosis of VTE must be initiated by the history and physical examination, and then must be performed ultrasound Doppler of lower limbs. Thus, the ultra-sonography/doppler examination will be done at the beginning and end of treatment and physical examination will be done periodically throughout the period of monitoring.
Following the guidelines proposed by the literature consulted, was established to test this methodology, which aims to demonstrate the non inferiority clinical heparin sodium 5.000UI / 0.25 mL sodium heparin on 5.000UI / 1.0 mL, both produced by Blausiegel Industry and Trade Ltda. in reducing the incidence of VTE. The two formulations are produced from the same material, but have different drug concentrations. Thus, there is a need to scientifically prove that the therapeutic activity and safety of the product test is non-inferior to the comparator drug (APP heparina - 5.000 USP/mL), allowing the sponsoring company to obtain the registration of the product in the concentration of 5000UI /0.25 mL in ANVISA at the proposed therapeutic indication in the study.
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 - BlausiegelHeparin Sodium 5.000UI/0.25mL |
| Ative comparator | Active comparator | Biological: Heparin sodium - APPHeparin Sodium 5.000USP/mL |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Accept all items described in Informed Consent, signing it in two ways;
- Age between 40 and 60 years without additional risk factors, which held more surgery (general, gynecological and urological);
- Women aged 18 to 40 years making use of estrogen;
- 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;
- 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 - BlausiegelHeparin sodium - 5.000UI/0.25mL, twice a day for 7 days and 2 hours before the surgery | Biological | Test |
| Heparin sodium - APPHeparin sodium - 5.000USP/mL, twice a day for 7 days and 2 hours before the surgery | Biological | Ative comparator |
Primary outcome
Incidence of venous thromboembolism during the 28 days of study
Time frame: 2h before the start of surgery; 1 d. after 1st administration; 3 days; 5 days; 7 days; 14 days; 21 days; 28 days
1 secondary outcome
Incidence of adverse reactions during the treatment period
Time frame: 1 d. after 1st administration; 3 days; 5 days; 7 days; 14 days; 21 days; 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing heparin sodium - Blausiegel and Heparin sodium - APP in people with Venous Thromboembolism, run by Azidus Brasil.
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 5 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: withdrawn, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of venous thromboembolism during the 28 days of study (time frame: 2h before the start of surgery; 1 d. after 1st administration; 3 days; 5 days; 7 days; 14 days; 21 days; 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 29 Mar 2013.