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临床试验/EUCTR2015-001127-24-FI
EUCTR2015-001127-24-FI进行中(未招募)1 期

Pharmacokinetics of enoxaparin after coronary artery bypass graft surgery

Tampere Heart Hospital0 个研究点目标入组 80 人开始时间: 2015年5月18日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Age: 18 to 90 years
  • BMI between 18-33 kg/m2
  • Elective on-pump CABG operation
  • Indication for post-operative pharmacological thromboprophylaxis
  • Written informed consent obtained from the patient or his/her legal representative
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 80
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 80

排除标准

  • -Other indications for anticoagulant therapy than thromboprophylaxis
  • -Known heparin induced thrombocytopenia (HIT), or hypersensitivity to enoxaparin or heparin
  • -Any long-term anticoagulant medication, expect low-dose aspirin
  • -Major bleeding within the last week unless definitively treated
  • Blood platelet count <20, P-TT <20 % or INR >1.7
  • -GFR less than 30 ml/min/1.73 m2 estimated from serum creatinine by applying Cockcroft–Gault equation 13 or chronic dialysis
  • Known HIV, HBV, or HCV infection

研究者

发起方
Tampere Heart Hospital

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