Cardiac Surgery
Conditions
Keywords
heparin cardiac surgery
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 at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding) at the end of the surgery.
Interventions
BIOLOGICALHeparin sodium Hipolabor
Heparin sodium Hipolabor 5.000 UI/mL
BIOLOGICALHeparin sodium APP
Heparin sodium APP 5.000 USP
Sponsors
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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; AND * Extracorporeal.
Exclusion criteria
* 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); * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of heparin of porcine origin in patients undergoing cardiovascular surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the average dose and and safety of porcine heparin. | 48 hours after surgery. | 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 |
Countries
Brazil
Outcome results
None listed