NCT00816023已完成2 期
CONSERV-1 (Clinical Outcomes and Safety Trial to Investigate Ecallantide's Effect on Reducing Surgical Blood Loss Volume) A Phase 2 Randomized Placebo-controlled Dose-ranging Study in Subjects Exposed to Cardio-pulmonary Bypass During Primary Coronary Artery Bypass Graft Surgery
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)29 个研究点 分布在 2 个国家目标入组 276 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 29
- 主要终点
- Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery
研究概览
简要总结
The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent (by study subject or appropriate legal representative) prior to any study-related procedure not part of normal medical care
- •Planned primary CABG surgery including the use of cardio-pulmonary bypass.
排除标准
- •Planned concomitant surgery including ASD repair, valve replacement, carotid endarterectomy, CABG combined procedures or any repeat sternotomy;
- •Body weight <55 kg;
- •Planned hypothermia (<28ºC);
- •Planned transfusion in the peri-operative or post-operative periods;
- •Planned transfusion of pre-operatively donated autologous blood;
- •Female subjects who are pregnant or lactating;
- •Planned use of desmopressin, lysine analogs, atrial natriuretic hormone or recombinant activated Factor VII;
- •Planned use of corticosteroids in the pump prime solution;
- •Ejection fraction <30% within 90 days prior to surgery;
- •Evidence of a myocardial infarction within 5 days prior to surgery;
- •History of stroke or transient ischemic attack within 3 months prior to surgery;
- •Hypotension or heart failure requiring the use of inotropes or mechanical devices within 24 hours prior to surgery;
- •Serum creatinine >2.0 mg/dL within 48 hours prior to surgery;
- •Serum hepatic enzymes above 2.5 times the upper limit of normal for the applicable laboratory;
- •Hematocrit <32% within 48 hours prior to surgery;
- •Platelet count below the normal range for the applicable laboratory within 14 days prior to surgery;
- •History of, or family history of, bleeding or clotting disorder or thrombophilia;
- •History of heparin-induced thrombocytopenia;
- •Prothrombin time and/or activated partial thromboplastin time >1.5 X normal range;
- •Serious intercurrent illness or active infection;
- •Any previous exposure to ecallantide;
- •Receipt of an investigational drug or device 30 days prior to participation in the current study;
- •Known allergy to any agent expected to be used in the intra-operative or post-operative periods; and
- •Administration of: Eptifibatide within 6 hours prior to surgery, Tirofiban HCl within 6 hours prior to surgery, *Enoxaparin sodium or other low-molecular-weight heparin <24 hours prior to surgery, Clopidogrel within 5 days prior to surgery, Ticlopidine within 7 days prior to surgery, Abciximab within 5 days prior to surgery, *Bivalirudin, argatroban or lepirudin within 6 hours prior to surgery, *Fondaparinux within 72 hours prior to surgery, Prasugrel within 10 days prior to surgery [*Prophylactic use permitted for the prevention of deep vein thrombosis.]
研究组 & 干预措施
Ecallantide Low Dose
Experimental
target steady state concentration of 0.15 mg/L
干预措施: ecallantide (Drug)
Ecallantide Medium Dose
Experimental
target steady state concentration of 0.75 mg/L
干预措施: ecallantide (Drug)
Ecallantide High Dose
Experimental
target steady state concentration of 2.25 mg/L
干预措施: ecallantide (Drug)
Placebo
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery
时间窗: Start of surgery up to 12 hours after the end of surgery
次要结局
- Treatment-emergent Adverse Events(Over the duration of the study.)
研究者
研究点 (29)
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