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

Primary Purpose

Prevention of Venous Thromboembolism

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Bovine Heparin
Porcine heparin
Sponsored by
Azidus Brasil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Venous Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • LAL Clinica Pesquisa e Desenvolvimento LtdaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

heparin of bovine origin

heparin of porcine origin

Arm Description

5.000UI/mL bottle with 5mL

5000 USP Heparin Units / mL vial with 10 mL vial

Outcomes

Primary Outcome Measures

Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa

Secondary Outcome Measures

Value of the total dose of heparin used, the activity and adequate reversal with the use of protamine.

Full Information

First Posted
February 19, 2010
Last Updated
January 27, 2011
Sponsor
Azidus Brasil
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1. Study Identification

Unique Protocol Identification Number
NCT01072955
Brief Title
Efficacy And Safety Of Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Azidus Brasil

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Venous Thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
heparin of bovine origin
Arm Type
Experimental
Arm Description
5.000UI/mL bottle with 5mL
Arm Title
heparin of porcine origin
Arm Type
Active Comparator
Arm Description
5000 USP Heparin Units / mL vial with 10 mL vial
Intervention Type
Biological
Intervention Name(s)
Bovine Heparin
Intervention Description
5.000UI/mL bottle with 5mL
Intervention Type
Biological
Intervention Name(s)
Porcine heparin
Intervention Description
5000 USP Heparin Units / mL vial with 10 mL vial
Primary Outcome Measure Information:
Title
Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa
Time Frame
(T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative
Secondary Outcome Measure Information:
Title
Value of the total dose of heparin used, the activity and adequate reversal with the use of protamine.
Time Frame
(T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Frederico, Dr.
Phone
+551938293822
Email
alexandre@lalclinica.com.br
Facility Information:
Facility Name
LAL Clinica Pesquisa e Desenvolvimento Ltda
City
Valinhos
State/Province
São Paulo
ZIP/Postal Code
13276-245
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karina Guerra
Phone
+551938293822
Email
karina@lalclinica.com.br

12. IPD Sharing Statement

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

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