Efficacy And Safety Of Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Azidus Brasil.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Azidus Brasil
ClinicalTrials.gov Identifier:
NCT01072955
First Posted: February 22, 2010
Last Update Posted: January 28, 2011
Information provided by:
Azidus Brasil
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Prevention of Venous Thromboembolism | Biological: Bovine Heparin Biological: Porcine heparin | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Prevention |
Resource links provided by NLM:
Further study details as provided by Azidus Brasil:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 104 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: heparin of bovine origin
5.000UI/mL bottle with 5mL
|
Biological: Bovine Heparin
5.000UI/mL bottle with 5mL
|
|
Active Comparator: heparin of porcine origin
5000 USP Heparin Units / mL vial with 10 mL vial
|
Biological: Porcine heparin
5000 USP Heparin Units / mL vial with 10 mL vial
|
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072955
Contacts
| Contact: Alexandre Frederico, Dr. | +551938293822 | alexandre@lalclinica.com.br |
Locations
| Brazil | |
| LAL Clinica Pesquisa e Desenvolvimento Ltda | Recruiting |
| Valinhos, São Paulo, Brazil, 13276-245 | |
| Contact: Karina Guerra +551938293822 karina@lalclinica.com.br | |
Sponsors and Collaborators
Azidus Brasil
More Information
| Responsible Party: | Dr. Alexandre Frederico, LAL Clinica |
| ClinicalTrials.gov Identifier: | NCT01072955 History of Changes |
| Other Study ID Numbers: |
HEPSBCCV1109BOV_EUR version 2 |
| First Submitted: | February 19, 2010 |
| First Posted: | February 22, 2010 |
| Last Update Posted: | January 28, 2011 |
| Last Verified: | January 2011 |
Additional relevant MeSH terms:
|
Thromboembolism Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Calcium heparin |
Heparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |