Efficacy and Safety of Sodium Heparin in Patients (Cristália)

Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass

The objective of this study is to 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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Biological: heparin sodium - Cristália; Biological: Heparin sodium APP

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Valinhos, São Paulo, Brazil, 13276-245
      • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Heparin sodium 5.000 UI - Cristália	Biological: heparin sodium - Cristália; Heparin sodium 5000UI - Cristália
Active Comparator: 2; Heparin Sodium 5.000 USP - APP	Biological: Heparin sodium APP; Heparin Sodium 5.000 USP - APP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of TTPA, Anti-Xa and ACT	Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
Comparison of bleeding	Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse reactions	Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative

Collaborators and Investigators

• Sponsor: Azidus Brasil
• Investigators: Principal Investigator: Alexandre Frederico, Doctor, LAL Clinical Reseach e Development Ltda

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 5, 2009
• First Submitted That Met QC Criteria: May 6, 2009
• First Posted (Estimate): May 7, 2009

Study Record Updates

• Last Update Posted (Estimate): February 25, 2013
• Last Update Submitted That Met QC Criteria: February 22, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: heparin cardiac surgery
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: HEPSBCCV0109_CRI; Heparin Cristália (Version 8)