Efficacy and Safety of Sodium Heparin (Hipolabor) in Patients (HEPSBCCV0109)

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 Hipolabor; Biological: Heparin sodium APP

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

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Valinhos, SP, Brazil, 13270-000
      • LAL Clínica Pesquisa e Desenvolvimento Ltda
    • Valinhos, SP, Brazil, 13270000
      • LAL Clínica

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
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Heparin sodium Hipolabor	Biological: Heparin sodium Hipolabor; Heparin sodium Hipolabor 5.000 UI/mL
ACTIVE_COMPARATOR: 2; Heparim Sodium APP 5.000 USP	Biological: Heparin sodium APP; Heparin sodium APP 5.000 USP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of heparin of porcine origin in patients undergoing cardiovascular surgery	Patients undergoing cardiovascular surgery and who require the assistance of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of coagulation markers ACT, aPTT, anti-Xa heparin serum and excessive blood loss (hemorrhage ) after the final surgery.	48 hours after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the average dose and and safety of porcine heparin.	Evaluate the mean dose of heparin used in surgery and its relationship to the dose of protamine chloride and the need for blood transfusions and blood products during and after the process	48 hours after surgery.

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ACTUAL): July 1, 2011
• 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_HIP; (Version 8)