Efficacy and Safety of Sodium Heparin in Patients

Azidus

Status and phase

Completed

Phase 3

Conditions

Cardiac Surgery

Treatments

Biological: Heparin sodium Blausiegel 1

Biological: Heparin sodium APP

Study type

Interventional

Funder types

Industry

Identifiers

NCT00894959

(Version 8)

Heparin Blausiegel 1

HEPSBCCV0109_BLA1

Details and patient eligibility

About

The objective of this study is 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.

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.