Efficacy and Safety of Sodium Heparin in Patients Submitted to Heart Surgery Using Bypass
Phase 3
- Conditions
- Cardiac Surgery
- Interventions
- Registration Number
- NCT00905216
- Lead Sponsor
- Azidus Brasil
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 104
Inclusion Criteria
- 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.
Exclusion Criteria
- 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);
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test heparin sodium - Bergamo Heparin sodium - Bergamo Comparator heparin sodium - APP Heparin APP
- Primary Outcome Measures
Name Time Method Comparison of TTPA, Anti-Xa and ACT Comparison of bleeding Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
- Secondary Outcome Measures
Name Time Method adverse reactions Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
Trial Locations
- Locations (1)
Lal Clinica Pesquisa E Desenvolvimento Ltda
🇧🇷Valinhos, SP, Brazil