Efficacy and Safety of Sodium Heparin in Patients (Cristália)

NCT00894998 | Completed Phase 3

• 2 other identifiers: HEPSBCCV0109_CRIHeparin Cristália (Version 8)
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Surgery

Keywords

heparin cardiac surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adverse reactions

  Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative

Study Arms (2)

1

EXPERIMENTAL

Heparin sodium 5.000 UI - Cristália

Biological: heparin sodium - Cristália

2

ACTIVE COMPARATOR

Heparin Sodium 5.000 USP - APP

Biological: Heparin sodium APP

Interventions

heparin sodium - Cristália BIOLOGICAL

Heparin sodium 5000UI - Cristália

1

Heparin sodium APP BIOLOGICAL

Heparin Sodium 5.000 USP - APP

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

LAL Clinica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, 13276-245, Brazil

Location

Study Officials

• Alexandre Frederico, Doctor

  LAL Clinical Reseach e Development Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 7, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2011
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

BR (1)