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

Randomized, Blind and Comparative Clinical Trial of Efficacy and Security of Unfractioned Heparin Sodium of Bovine Origin in Patients Submitted to Cardiovascular Surgery With Cardiopulmonary Bypass

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01072747

Enrollment

104

Registered

2010-02-22

Start date

2010-04-30

Completion date

2011-11-30

Last updated

2011-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Venous Thromboembolism

Brief summary

The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Bergamo Laboratory ACTIPARIN ® 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.

Interventions

BIOLOGICALbovine heparin

5.000UI/mL bottle with 5mL

BIOLOGICALPorcine heparin

5000 USP Heparin Units / mL vial with 10 mL vial

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa	(T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative

Secondary

Measure	Time frame
Value of the total dose of heparin used, the activity and adequate reversal with the use of protamine.	(T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative

Countries

Brazil

Contacts

Primary ContactAlexandre Frederico, Physician

alexandre@lalclinica.com.br55 19 3829-3822

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026