Status:
COMPLETED
Efficacy and Safety of Sodium Heparin in Patients (Cristália)
Lead Sponsor:
Azidus Brasil
Conditions:
Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00894998
Start Date
June 1 2009
End Date
December 1 2011
Last Update
February 25 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13276-245