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Efficacy And Safety Of Unfractionated 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

About this trial

This is an interventional treatment 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

Laboratory Bergamo Ltda. 5.000UI/mL bottle with 5mL

APP Pharmaceuticals

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

NCT ID

NCT01072747

First Posted

February 19, 2010

Last Updated

January 27, 2011

Sponsor

Azidus Brasil

1. Study Identification

Unique Protocol Identification Number

NCT01072747

Brief Title

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

Official Title

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

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 2011 (Anticipated)

Study Completion Date

November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Azidus Brasil

4. Oversight

Data Monitoring Committee

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 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.

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

Treatment

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

Laboratory Bergamo Ltda. 5.000UI/mL bottle with 5mL

Arm Title

heparin of porcine origin

Arm Type

Active Comparator

Arm Description

APP Pharmaceuticals

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

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, Physician

Phone

55 19 3829-3822

alexandre@lalclinica.com.br

Facility Information:

Facility Name

LAL Clinica Pesquisa e Desenvolvimento Ltda

City

Valinhos

State/Province

ZIP/Postal Code

13270000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandre Frederico, Physician

Phone

55 19 3829-3822

alexandre@lalclinica.com.br

12. IPD Sharing Statement

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

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