Hip Fracture SurgeryPhase 3HEP-SCNCT01352039
A Non-inferiority Study Comparing Two Heparin Sodium Preparations in Hip Fracture Surgery
A Phase 3 study testing Heparin Sodium - Eurofarma and Heparin Sodium - APP Pharmaceuticals in people with Hip Fracture Surgery, run by Eurofarma Laboratorios S.A. at 5 sites in Brazil.
Trial summary
The primary objective and endpoints of the study is compare the efficacy of two products containing heparin sodium, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Hip Fracture Surgery
- What is being tested?
- Heparin Sodium - Eurofarma and Heparin Sodium - APP Pharmaceuticals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 5 sitesBrazil
- Study dates
- Oct 2011to Oct 2012
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be enrolled in this study, eligible patients must meet all criteria below:
- ICF signing;
- Aged 60 to 85 years old;
- Indication of hip orthopedic surgery due to fracture occurred within the last 5 days;
- Normal coagulation profile or with alterations up to 25% of normal values.
Who cannot join
- Patients who meet any of the following criteria will not be eligible for the study:
- Previous hip surgery;
- Fracture secondary to the presence of metastasis;
- Recent traumatic brain, thoracic, or abdominal injury (up to 30 days before study start);
- Recent occurrence (up to 30 days before study start) of cerebrovascular accident;
- Serum concentration of hemoglobin below 9 g/dL;
Show all 15Show fewer
- Prior occurrence (in the last 5 years) of confirmed or suspected thromboembolic event;
- Occurrence of major bleeding in the last 6 months (any spontaneous gastrointestinal bleeding; central nervous system bleeding; massive epistaxis, or gum bleeding; gross hematuria, or vaginal bleeding);
- Confirmed or suspected blood dyscrasia;
- Diagnosis of neoplasm other than in situ in the last 24 months or any active neoplasm (neoplasms in situ do not prevent patient from participating);
- Liver or kidney failure;
- Clinically significant gastrointestinal cardiovascular, neurological disease, or laboratory abnormalities, which at the investigator's opinion, may interfere with individual's participation in the study or with assessment of individual's response to treatment;
- Hypersensitivity to heparin;
- Previous use (15 days before study start) of oral anticoagulants or expected use during the study (see Appendix B);
- Recent participation (previous 12 months) in a clinical trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150221
Centro de Pesquisa Clínica da Santa Casa de Misericórida de Juíz de Fora
Juiz de Fora, Minas Gerais, 36021-630
Irmandade Santa Casa de Misericórdia de Marília
Marília, São Paulo, 17515-900
Associação Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000
About this study
Official title: A Phase III, Non-inferiority, Randomized, Double-blind Trial Comparing Eurofarma Unfractionated Sodium Heparin 5,000 IU to APP Pharmaceuticals Unfractionated Sodium Heparin 5,000 IU in the Thromboprophylaxis of Geriatric Patients Who Underwent Hip Fracture Surgery.
The primary objective and endpoints of the study is compare the efficacy of two products containing heparin sodium, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.
Read the detailed description
The primary objective of the study is to assess the efficacy of unfractionated heparin sodium of porcine origin (Eurofarma) in the prophylaxis of VTE relative to unfractionated heparin sodium of porcine origin from APP Pharmaceuticals. The primary endpoint will be the frequency of DVT determined by Doppler ultrasound (DUS).
- Conditions
- Hip Fracture Surgery
- Being tested
- Heparin Sodium - Eurofarma, Heparin Sodium - APP Pharmaceuticals
- Keywords
- Heparin Sodium, Thromboprophylaxis, Hip Fracture Surgery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin Sodium - EurofarmaBiological
Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI
Heparin Sodium - APP PharmaceuticalsBiological
Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI
| Study group | Role | What they receive |
|---|---|---|
| Heparin Sodium - Eurofarma | Experimental | Not described Receives: Biological: Heparin Sodium - Eurofarma |
| Heparin Sodium - APP Pharmaceuticals | Active comparator | Not described Receives: Biological: Heparin Sodium - APP Pharmaceuticals |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS).
Measured: 6 months
Secondary outcomes (1)
The Secundary endpoint will be proximal and distal DVT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Fracture SurgeryStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352039
- Sponsor's protocol ID
- EF098 - HEP-SC
- Acronym
- HEP-SC
- Status last verified
- Oct 2012
- First submitted
- 10 May 2011
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Non-inferiority, Randomized, Double-blind Trial Comparing Eurofarma Unfractionated Sodium Heparin 5,000 IU to APP Pharmaceuticals Unfractionated Sodium Heparin 5,000 IU in the Thromboprophylaxis of Geriatric Patients Who Underwent Hip Fracture Surgery.
- ClinicalTrials.gov ID
- NCT01352039
- Acronym / sponsor ID
- HEP-SC / EF098 - HEP-SC
- Conditions
- Hip Fracture Surgery
- Keywords
- Heparin Sodium, Thromboprophylaxis, Hip Fracture Surgery.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 544 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 May 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 primary objective and endpoints of the study is compare the efficacy of two products containing heparin sodium, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.
Detailed description
The primary objective of the study is to assess the efficacy of unfractionated heparin sodium of porcine origin (Eurofarma) in the prophylaxis of VTE relative to unfractionated heparin sodium of porcine origin from APP Pharmaceuticals. The primary endpoint will be the frequency of DVT determined by Doppler ultrasound (DUS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin Sodium - Eurofarma | Experimental | Biological: Heparin Sodium - Eurofarma |
| Heparin Sodium - APP Pharmaceuticals | Active comparator | Biological: Heparin Sodium - APP Pharmaceuticals |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ICF signing;
- Aged 60 to 85 years old;
- Indication of hip orthopedic surgery due to fracture occurred within the last 5 days;
- Normal coagulation profile or with alterations up to 25% of normal values.
Key exclusion criteria (15 listed)
- Previous hip surgery;
- Fracture secondary to the presence of metastasis;
- Recent traumatic brain, thoracic, or abdominal injury (up to 30 days before study start);
- Recent occurrence (up to 30 days before study start) of cerebrovascular accident;
- Serum concentration of hemoglobin below 9 g/dL;
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 - EurofarmaHeparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI | Biological | Heparin Sodium - Eurofarma |
| Heparin Sodium - APP PharmaceuticalsHeparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI | Biological | Heparin Sodium - APP Pharmaceuticals |
Primary outcome
The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS).
Time frame: 6 months
1 secondary outcome
The Secundary endpoint will be proximal and distal DVT
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
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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.
5 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 Heparin Sodium - Eurofarma and Heparin Sodium - APP Pharmaceuticals in people with Hip Fracture Surgery, run by Eurofarma Laboratorios S.A. at 5 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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 was stopped early. 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?
The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS). (time frame: 6 months). 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 16 Oct 2012.