NCT00888940已完成2 期
CONSERV - 2 (Clinical Outcomes and Safety Trial to Investigate Ecallantide's Effect on Reducing Surgical Blood Loss Volume) - A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)34 个研究点 分布在 3 个国家目标入组 243 人开始时间: 2009年6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
- 243
- 试验地点
- 34
- 主要终点
- Cumulative Volume of Packed Red Blood Cells Transfused
研究概览
简要总结
A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
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) prior to any study-related procedure not part of normal medical care;
- •Male or female between the ages of 18 and 85 years old, inclusive; and
- •Planned cardiac surgery using cardio-pulmonary bypass, for one of the following procedures: any repeat sternotomy; surgery to repair or replace more than one valve; combined CABG plus repair or replacement of at least one valve
- •If female, subject is non-lactating, and is either:Not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy;Of childbearing potential but is not pregnant as confirmed by negative pregnancy test at time of screening (based on the β-subunit of HCG), and is practicing the barrier method of birth control along with one of the following methods: oral or parenteral contraceptives for three months prior to study drug administration, a vasectomized partner, or abstinence from sexual intercourse.
排除标准
- •Planned primary CABG, single valve repair or replacement surgery, or any off pump procedure;
- •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 (other than study medication), 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 (aspartate aminotransferase or alanine aminotransferase) 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 (e.g. von Willebrand's Disease, idiopathic thrombocytopenia purpura) or thrombophilia such as anti-thrombin III deficiency or Factor V Leiden mutation;
- •History of heparin-induced thrombocytopenia;
- •Prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) >1.5 X normal range unless subject received heparin within 24 hours of test;
- •Serious intercurrent illness or active infection (e.g. endocarditis, sepsis, active malignancy requiring treatment);
- •Any previous exposure to ecallantide;
- •Receipt of an investigational drug or device 30 days prior to participation in the current study;
- •Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study;
- •Inability to comply with the protocol for the duration of the 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 hydrochloride within 6 hours prior to surgery, (Enoxaparin sodium or other low-molecular-weight heparin <24 hours prior to surgery), Prasugrel within 10 days prior to surgery, Clopidogrel within 3 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), Chlorpromazine within 7 days prior to surgery (Prophylactic use permitted for the prevention of deep vein thrombosis.)
- •Planned use of heparin bonded bypass circuits;
- •Known allergy or hypersensitivity to tranexamic acid or any of the other ingredients;
- •Disturbance of color sense;
- •Evidence of hematuria or any acute thromboses or thromboembolic diseases such as deep vein thrombosis, pulmonary embolism, or vertebral vein thrombosis.
研究组 & 干预措施
ecallantide
Experimental
干预措施: Ecallantide (Drug)
Cyklokapron(R)
Active Comparator
干预措施: Cyklokapron(R) (Drug)
结局指标
主要结局
Cumulative Volume of Packed Red Blood Cells Transfused
时间窗: 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 (34)
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