Efficacy and Safety of Sodium Heparin in Patients

• Sponsor: Azidus Brasil (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00894959
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

The objective of this study is 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery	Biological: Heparin sodium Blausiegel 1; Biological: Heparin sodium APP	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Heparin Sodium Blausiegel 1	Biological: Heparin sodium Blausiegel 1; Heparin sodium Blausiegel 1 5.000 UI
Experimental: Active Comparator heparin sodium - APP 5.000 USP	Biological: Heparin sodium APP; Heparin sodium APP 5.000 USP

Outcome Measures

Primary Outcome Measures

1. Comparison of TTPA, Anti-Xa and ACT [Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative]

2. Comparison of bleeding [Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative]

Secondary Outcome Measures

1. Adverse reactions [Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LAL clinica pesquisa e desenvolvimento ltda	Valinhos	SP	Brazil	13270000

Sponsors and Collaborators

• Azidus Brasil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00894959
• Other Study ID Numbers: HEPSBCCV0109_BLA1; Heparin Blausiegel 1; (Version 8)
• First Posted: May 7, 2009
• Last Update Posted: Feb 25, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by , ,: heparin cardiac surgery
• Additional relevant MeSH terms: Heparin; Calcium heparin

Study Results

No Results Posted as of Feb 25, 2013