Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Comparison of TTPA, Anti-Xa and ACT
研究概览
简要总结
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.
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 (Participant)
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 aged above 18 years;
- •Patients with cardiac surgery and requiring movement; AND
- •Extracorporeal.
排除标准
- •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.
结局指标
主要结局
Comparison of TTPA, Anti-Xa and ACT
时间窗: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
Comparison of bleeding
时间窗: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
次要结局
- adverse reactions(Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative)