Efficacy And Safety Of Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass

Azidus Brasil2 个研究点分布在 1 个国家目标入组 104 人开始时间: 2010年4月最近更新: 2011年1月28日

适应症

试验速览

阶段: 3 期
发起方: Azidus Brasil
入组人数: 104
试验地点: 2
主要终点: Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Eurofarma Laboratory product when compared to porcine heparin APP Pharmaceutical in patients undergoing surgery cardiovascular disease and who require cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of markers of coagulation ACT, aPTT, anti-Xa heparin levels and the excessive blood loss (hemorrhage) after the end of surgery.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Single (Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients who agree with all aspects of the study and sign the FICT;
•Patients of both sexes;
•Patients over the age of 18 years;
•Patients with indication for cardiac surgery requiring cardiopulmonary bypass.

排除标准

•Patients with hematological disorders that compromise the surgical outcome (eg, myeloproliferative disorders, anemia, Hb <11.0 g / dL, platelets <100,000 mm3);
•Patients with disorders of hemostasis (INR> 1.40) (APTTr> 1.40);
•Patients with renal impairment (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 a history of heparin-induced thrombocytopenia;
•infection (eg endocarditis, septicemia and pneumonia);
•Reoperations;
•Use of antiplatelet agents (clopidogrel and ticlopidine) for less than 7 days;
•Use of aspirin for less than 5 days;
•Use of heparin, low molecular weight less than 24 hours;
•Use of unfractionated heparin for less than 12 hours.

结局指标

主要结局

Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa

时间窗: (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative

次要结局

Value of the total dose of heparin used, the activity and adequate reversal with the use of protamine.((T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative)

研究者

发起方

Azidus Brasil

申办方类型

Industry

研究点 (2)

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