Cardiac SurgeryPhase 3HEPSBCCV0109NCT00894673

Efficacy and Safety of Sodium Heparin (Hipolabor) in Patients

A Phase 3 study testing Heparin sodium Hipolabor and Heparin sodium APP in people with Cardiac Surgery, run by Azidus Brasil at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after… 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 Hipolabor and Heparin sodium APP
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 2 sitesBrazil
Study dates: Jul 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; AND
Extracorporeal.

Who cannot join

Patients with hematological disorders that compromise the surgical changes (eg 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 (eg 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; OR
Use of non-fractioned heparin for less than 12 hours.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

Lal Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, 13270-000
LAL Clinica
Valinhos, São Paulo, 13270000

Other trials in Brazil

About this study

Official title: Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass

Conditions: Cardiac Surgery
Being tested: Heparin sodium Hipolabor, Heparin sodium APP
Keywords: heparin cardiac surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Heparin sodium HipolaborBiological
Heparin sodium Hipolabor 5.000 UI/mL
Heparin sodium APPBiological
Heparin sodium APP 5.000 USP

Study groups in NCT00894673
Study group	Role	What they receive
1	Experimental	Heparin sodium Hipolabor Receives: Biological: Heparin sodium Hipolabor
2	Active comparator	Heparim Sodium APP 5.000 USP Receives: Biological: Heparin sodium APP

What is being measured

The primary outcome is the main question the study is designed to answer.

Effectiveness of heparin of porcine origin in patients undergoing cardiovascular surgery
Patients undergoing cardiovascular surgery and who require the assistance of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of coagulation markers ACT, aPTT, anti-Xa heparin serum and excessive blood loss (hemorrhage ) after the final surgery.
Measured: 48 hours after surgery.

Secondary outcomes (1)

Evaluation of the average dose and and safety of porcine heparin.
Evaluate the mean dose of heparin used in surgery and its relationship to the dose of protamine chloride and the need for blood transfusions and blood products during and after the process
Measured: 48 hours after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Dec 2011

First posted7 May 2009 (estimated)
Study startJul 2009
Primary completionJul 2011
Study completionDec 2011

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 (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00894673
Sponsor's protocol ID: HEPSBCCV0109_HIP
Other IDs: (Version 8)
Acronym: HEPSBCCV0109
Status last verified: Feb 2013
First submitted: 5 May 2009
Last updated: 25 Feb 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiac Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2013. 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: NCT00894673
Acronym / sponsor ID: HEPSBCCV0109 / HEPSBCCV0109_HIP
Conditions: Cardiac Surgery
Keywords: heparin cardiac surgery
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Azidus BrasilIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Jul 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 7 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: Heparin sodium HipolaborHeparin sodium Hipolabor
2	Active comparator	Biological: Heparin sodium APPHeparim Sodium APP 5.000 USP

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 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; AND
Extracorporeal.

Key exclusion criteria (14 listed)

Patients with hematological disorders that compromise the surgical changes (eg 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 HipolaborHeparin sodium Hipolabor 5.000 UI/mL	Biological	1
Heparin sodium APPHeparin sodium APP 5.000 USP	Biological	2

Primary outcome

Effectiveness of heparin of porcine origin in patients undergoing cardiovascular surgery
Time frame: 48 hours after surgery.
Patients undergoing cardiovascular surgery and who require the assistance of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of coagulation markers ACT, aPTT, anti-Xa heparin serum and excessive blood loss (hemorrhage ) after the final surgery.

1 secondary outcome

Evaluation of the average dose and and safety of porcine heparin.
Time frame: 48 hours after surgery.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.

Related trials for Cardiac Surgery

Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction

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.

2 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 Hipolabor and Heparin sodium APP in people with Cardiac Surgery, run by Azidus Brasil at 2 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 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: finished, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Effectiveness of heparin of porcine origin in patients undergoing cardiovascular surgery (time frame: 48 hours after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00894673.

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 25 Feb 2013.