Cardiac SurgeryPhase 3NCT00905216
Efficacy and Safety of Sodium Heparin in Patients Submitted to Heart Surgery Using Bypass
A Phase 3 study testing heparin sodium - Bergamo and heparin sodium - APP in people with Cardiac Surgery, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The objective of this study is to verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery that require the aid of cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- heparin sodium - Bergamo and heparin sodium - APP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2009to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who agree with all aspects of the study and sign the FICT;
- Patients of both sexes;
- Patients aged above 18 years;
- Patients with cardiac surgery and requiring movement Extracorporeal.
Who cannot join
- Patients with hematological disorders that compromise the surgical changes (e.g., myeloproliferative syndromes, anemia Hb < 11.0 g/dL,
- Platelets < 150,000 mm3);
- Patients with disorders of hemostasis (INR > 1.40) (rTTPA > 1.40);
- Patients with renal dysfunction (creatinine > 1.50);
- Patients with deep hyperthermia;
- Liver disease (AST and ALT > 2 times that of the reference value);
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- Patients with a history of allergy to heparin or protamine;
- Patients with history of heparin-induced thrombocytopenia;
- Tables infection (e.g., endocarditis, infection of immune human (HIV), hepatitis B and C, septicemia and pneumonia);
- Reoperations;
- Use of antiplatelet (clopidogrel and ticlopidine) for less than 7 days;
- Use of acetylsalicylic acid is less than 5 days;
- Use of low molecular weight heparin for less than 24 hours;
- Use of non-fractioned heparin for less than 12 hours.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, 13270000
Alexandre Frederico, Physician, 55 19 3829-3822, dr.alexandre@alclinica.com.br
alexandre Frederico, Physician
About this study
Official title: Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass
The objective of this study is to verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery that require the aid of cardiopulmonary bypass. The effectiveness will be determined through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation trichloroacetic acid (TCA), alpha-tocopherol transfer protein (TTPA), Anti-Xa, heparin bioavailability and excessive loss of blood (bleeding) at the end of the surgery.
- Conditions
- Cardiac Surgery
- Being tested
- heparin sodium - Bergamo, heparin sodium - APP
- Keywords
- heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparin sodium - BergamoDrug
5.000 UI/mL
heparin sodium - APPDrug
5.000 USP
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Heparin sodium - Bergamo Receives: Drug: heparin sodium - Bergamo |
| Comparator | Active comparator | Heparin APP Receives: Drug: heparin sodium - APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of TTPA, Anti-Xa and ACT Comparison of bleeding
Measured: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
Secondary outcomes (1)
adverse reactions
Measured: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2009 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905216
- Sponsor's protocol ID
- HEPSBCCV0109_BER
- Other IDs
- Heparin Bergamo, (Version 8)
- Status last verified
- Jan 2011
- First submitted
- 5 May 2009
- Last updated
- 28 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass
- ClinicalTrials.gov ID
- NCT00905216
- Acronym / sponsor ID
- HEPSBCCV0109_BER
- Conditions
- Cardiac Surgery
- Keywords
- heparin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 20 May 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 objective of this study is to verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery that require the aid of cardiopulmonary bypass. The effectiveness will be determined through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation trichloroacetic acid (TCA), alpha-tocopherol transfer protein (TTPA), Anti-Xa, heparin bioavailability and excessive loss of blood (bleeding) at the end of the surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: heparin sodium - BergamoHeparin sodium - Bergamo |
| Comparator | Active comparator | Drug: heparin sodium - APPHeparin APP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who agree with all aspects of the study and sign the FICT;
- Patients of both sexes;
- Patients aged above 18 years;
- Patients with cardiac surgery and requiring movement Extracorporeal.
Key exclusion criteria (14 listed)
- Patients with hematological disorders that compromise the surgical changes (e.g., myeloproliferative syndromes, anemia Hb < 11.0 g/dL,
- Platelets < 150,000 mm3);
- Patients with disorders of hemostasis (INR > 1.40) (rTTPA > 1.40);
- Patients with renal dysfunction (creatinine > 1.50);
- Patients with deep hyperthermia;
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 - Bergamo5.000 UI/mL | Drug | Test |
| heparin sodium - APP5.000 USP | Drug | Comparator |
Primary outcome
Comparison of TTPA, Anti-Xa and ACT Comparison of bleeding
Time frame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
1 secondary outcome
adverse reactions
Time frame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
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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.
1 site 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 - Bergamo and heparin sodium - APP in people with Cardiac Surgery, 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 28 Jan 2011. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact alexandre Frederico, physician (55 19 3829-3822, dr.alexandre@alclinica.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of TTPA, Anti-Xa and ACT Comparison of bleeding (time frame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative). 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 28 Jan 2011.