EUCTR2011-004666-15-DE进行中（未招募）1 期
A Phase II, double-blind, parallel group, dose-selection study to compare antifibrinolytic MDCO-2010 vs. placebo and tranexamic acid in reducing blood loss in patients undergoing primary cardiac surgery
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •In Stage 1: Planned primary isolated CABG surgery
- •In Stage 2: Planned primary isolated CABG surgery, OR Planned primary combined CABG and aortic valve replacement surgery
- •Men, aged 18 to 85 years, OR
- •Women, aged 18 to 85 years, either of postmenopausal status, defined as =1 year since last menstrual period, or with a medical history of hysterectomy or bilateral oophorectomy
- •Written informed consent
- •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 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 135
排除标准
- •Off-pump surgery or hybrid procedures
- •Patients undergoing repeat sternotomy
- •Planned deep hypothermic circulatory arrest (<28°C)
- •Known allergy, sensitivity or contraindications to tranexamic acid
- •Epileptiform disorders, history of seizure activity or anticonvulsive medication
- •Administration of clopidogrel, ticagrelor or ticlopidine within 5 days prior to surgery or prasugrel within 7 days prior to surgery
- •Administration of low molecular weight heparin, glycoprotein IIb/IIIa inhibitors or fondaparinux within 12 hours prior to surgery
- •Known history of coronary stent thrombosis within the last 3 months
- •History of stroke or transient ischemic attack within 3 months prior to surgery
- •Left ventricular ejection fraction (LVEF) =35% or Grade III or IV
- •Body mass index <20 or >35
- •Known active gastrointestinal (GI) or other non-catheterization bleeding within 7 days prior to surgery
- •Preoperative coagulation abnormalities defined as:
- •–Platelet count <100,000/?L or >350,000/?L, or
- •–International normalized ratio (INR) >1.5, or
- •–Hematocrit <36%, or
- •–Activated partial thromboplastin time (aPTT) >1.5 x the upper limit of normal (ULN)
- •Major surgical procedures within 30 days prior to surgery
- •Patient inability or refusal to receive donor blood products if necessary
- •Creatinine >2 mg/dL or estimated glomerular filtration rate (eGFR) (calculated using Modification of Diet in Renal Disease [MDRD] equation) <30 mL/min
- •Known heparin-induced thrombocytopenia type II
- •Known history of thrombophilia, such as AT-III, Protein C or Protein S deficiency, Factor V Leiden, anti-phospholipid syndrome
- •Known active liver disease
- •Any condition requiring ongoing chronic immunosuppressive medication
- •Malignancy within 5 years prior to surgery
- •Receipt of an investigational drug or device within 60 days prior to surgery
- •Any other condition which, in the opinion of the Principal Investigator, would put the subject at increased risk from participating in the study or otherwise prevent a patient’s participation in the study
研究者
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