Efficacy And Safety Of Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Azidus Brasil.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Azidus Brasil
Information provided by:
Azidus Brasil
ClinicalTrials.gov Identifier:
NCT01072955
First received: February 19, 2010
Last updated: January 27, 2011
Last verified: January 2011
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072955
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | February 19, 2010 |
| Last Updated: | January 27, 2011 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Additional relevant MeSH terms:
|
Calcium heparin Heparin Thromboembolism Venous Thromboembolism Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 26, 2016