NCT01072747Unknown3 期
Randomized, Blind and Comparative Clinical Trial of Efficacy and Security of Unfractioned Heparin Sodium of Bovine Origin in Patients Submitted to Cardiovascular Surgery With Cardiopulmonary Bypass
适应症
试验速览
- 阶段
- 3 期
- 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
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 Bergamo Laboratory ACTIPARIN ® 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
- Treatment
- 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
研究点 (2)
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