Efficacy And Safety Of Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prevention of Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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heparin of bovine origin

5.000UI/mL bottle with 5mL

Group Type EXPERIMENTAL

Bovine Heparin

Intervention Type BIOLOGICAL

5.000UI/mL bottle with 5mL

heparin of porcine origin

5000 USP Heparin Units / mL vial with 10 mL vial

Group Type ACTIVE_COMPARATOR

Porcine heparin

Intervention Type BIOLOGICAL

5000 USP Heparin Units / mL vial with 10 mL vial

Interventions

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Bovine Heparin

5.000UI/mL bottle with 5mL

Intervention Type BIOLOGICAL

Porcine heparin

5000 USP Heparin Units / mL vial with 10 mL vial

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No