Prevention of Venous ThromboembolismPhase 3NCT01072955
Efficacy And Safety Of Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass
A Phase 3 study testing Bovine Heparin and Porcine heparin in people with Prevention of Venous Thromboembolism, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Eurofarma Laboratory product when compared to porcine heparin APP Pharmaceutical in patients undergoing surgery cardiovascular disease and who require cardiopulmonary bypass… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention of Venous Thromboembolism
- What is being tested?
- Bovine Heparin and Porcine heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Oct 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 over the age of 18 years;
- Patients with indication for cardiac surgery requiring cardiopulmonary bypass.
Who cannot join
- Patients with hematological disorders that compromise the surgical outcome (eg, myeloproliferative disorders, anemia, Hb <11.0 g / dL, platelets <100,000 mm3);
- Patients with disorders of hemostasis (INR> 1.40) (APTTr> 1.40);
- Patients with renal impairment (creatinine> 1.50);
- Patients with deep hyperthermia;
- Liver disease (AST and ALT> 2 times that of the reference value);
- Patients with a history of allergy to heparin or protamine;
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- Patients with a history of heparin-induced thrombocytopenia;
- infection (eg endocarditis, septicemia and pneumonia);
- Reoperations;
- Use of antiplatelet agents (clopidogrel and ticlopidine) for less than 7 days;
- Use of aspirin for less than 5 days;
- Use of heparin, low molecular weight less than 24 hours;
- Use of unfractionated 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, 13276-245
Karina Guerra, +551938293822, karina@lalclinica.com.br
About this study
The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Eurofarma Laboratory product when compared to porcine heparin APP Pharmaceutical in patients undergoing surgery cardiovascular disease and who require cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of markers of coagulation ACT, aPTT, anti-Xa heparin levels and the excessive blood loss (hemorrhage) after the end of surgery.
- Conditions
- Prevention of Venous Thromboembolism
- Being tested
- Bovine Heparin, Porcine heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine HeparinBiological
5.000UI/mL bottle with 5mL
Porcine heparinBiological
5000 USP Heparin Units / mL vial with 10 mL vial
| Study group | Role | What they receive |
|---|---|---|
| heparin of bovine origin | Experimental | 5.000UI/mL bottle with 5mL Receives: Biological: Bovine Heparin |
| heparin of porcine origin | Active comparator | 5000 USP Heparin Units / mL vial with 10 mL vial Receives: Biological: Porcine heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa
Measured: (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative
Secondary outcomes (1)
Value of the total dose of heparin used, the activity and adequate reversal with the use of protamine.
Measured: (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2010 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072955
- Sponsor's protocol ID
- HEPSBCCV1109BOV_EUR
- Other IDs
- version 2
- Status last verified
- Jan 2011
- First submitted
- 19 Feb 2010
- 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
- Efficacy And Safety Of Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT01072955
- Acronym / sponsor ID
- HEPSBCCV1109BOV_EUR
- Conditions
- Prevention of Venous Thromboembolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 22 Feb 2010 (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 of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Eurofarma Laboratory product when compared to porcine heparin APP Pharmaceutical in patients undergoing surgery cardiovascular disease and who require cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of markers of coagulation ACT, aPTT, anti-Xa heparin levels and the excessive blood loss (hemorrhage) after the end of surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heparin of bovine origin | Experimental | Biological: Bovine Heparin5.000UI/mL bottle with 5mL |
| heparin of porcine origin | Active comparator | Biological: Porcine heparin5000 USP Heparin Units / mL vial with 10 mL vial |
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 over the age of 18 years;
- Patients with indication for cardiac surgery requiring cardiopulmonary bypass.
Key exclusion criteria (13 listed)
- Patients with hematological disorders that compromise the surgical outcome (eg, myeloproliferative disorders, anemia, Hb <11.0 g / dL, platelets <100,000 mm3);
- Patients with disorders of hemostasis (INR> 1.40) (APTTr> 1.40);
- Patients with renal impairment (creatinine> 1.50);
- Patients with deep hyperthermia;
- Liver disease (AST and ALT> 2 times that of the reference value);
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 |
|---|---|---|
| Bovine Heparin5.000UI/mL bottle with 5mL | Biological | heparin of bovine origin |
| Porcine heparin5000 USP Heparin Units / mL vial with 10 mL vial | Biological | heparin of porcine origin |
Primary outcome
Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa
Time frame: (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative
1 secondary outcome
Value of the total dose of heparin used, the activity and adequate reversal with the use of protamine.
Time frame: (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (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 Bovine Heparin and Porcine heparin in people with Prevention of 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 13 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, Dr. (+551938293822, alexandre@lalclinica.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa (time frame: (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (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.