Efficacy and Safety of Sodium Heparin
This study has been completed.
Sponsor:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT00894985
First received: May 5, 2009
Last updated: February 22, 2013
Last verified: February 2013
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Purpose
The objective of this study is to verify, through a randomized, open, 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 | Intervention | Phase |
|---|---|---|
|
Cardiac Surgery |
Biological: heparin sodium - blausiegel Biological: heparin sodium - APP |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass |
Resource links provided by NLM:
Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Primary Outcome Measures:
- Comparison of TTPA, Anti-Xa and ACT [ Time Frame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative ] [ Designated as safety issue: No ]
- Comparison of bleeding [ Time Frame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- adverse reactions [ Time Frame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative ] [ Designated as safety issue: Yes ]
| Enrollment: | 104 |
| Study Start Date: | June 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Heparin 5.000UI
|
Biological: heparin sodium - blausiegel
heparin sodium 5.000UI
|
|
Active Comparator: 2
Heparin 5.000USP - APP
|
Biological: heparin sodium - APP
heparin sodium 5.000 USP - APP
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 More Information
No publications provided
| Responsible Party: | Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda |
| ClinicalTrials.gov Identifier: | NCT00894985 History of Changes |
| Other Study ID Numbers: | HEPSBCCV0109_BLA2, Heparin Blausiegel 2, (Version 8) |
| Study First Received: | May 5, 2009 |
| Last Updated: | February 22, 2013 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
|
heparin cardiac surgery |
Additional relevant MeSH terms:
|
Calcium heparin Heparin Anticoagulants Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013