EUCTR2008-008354-23-PL进行中（未招募）不适用
CONSERVTM – 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 - CONSERV-2
Cubist Pharmaceuticals,INC0 个研究点目标入组 300 人开始时间: 2009年3月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •1.Written informed consent (by study subject) prior to any study-related procedure not part of normal medical care;
- •2.Male or female between the ages of 18 and 85 years old, inclusive; and
- •3.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
- •4.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 historectomy;
- •Of childbearing potential but is not pregnant as confirmed by negative pregnancy test at time of screening (based on the ß-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.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Planned primary CABG, single valve repair or replacement surgery, or any off pump procedure;
- •2.Body weight <55 kg;
- •3.Planned hypothermia (<28ºC);
- •4.Planned transfusion in the peri-operative or post-operative periods;
- •5.Planned transfusion of pre-operatively donated autologous blood;
- •6.Female subjects who are pregnant or lactating;
- •7.Planned use of desmopressin, lysine analogs (other than study medication), atrial natriuretic hormone or recombinant activated Factor VII;
- •8.Planned use of corticosteroids in the pump prime solution;
- •9.Ejection fraction <30% within 90 days prior to surgery;
- •10.Evidence of a myocardial infarction within 5 days prior to surgery;
- •11.History of stroke or transient ischemic attack within 3 months prior to surgery;
- •12.Hypotension or heart failure requiring the use of inotropes or mechanical devices within 24 hours prior to surgery;
- •13.Serum creatinine >2.0 mg/dL within 48 hours prior to surgery;
- •14.Serum hepatic enzymes (aspartate aminotransferase or alanine aminotransferase) above 2.5 times the upper limit of normal for the applicable laboratory;
- •15.Hematocrit <32% within 48 hours prior to surgery;
- •16.Platelet count below the normal range for the applicable laboratory within 14 days prior to surgery;
- •17.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;
- •18.History of heparin-induced thrombocytopenia;
- •19.Prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) >1.5 X normal range unless subject received heparin within 24 hours of test;
- •20.Serious intercurrent illness or active infection (e.g. endocarditis, sepsis, active malignancy requiring treatment);
- •21.Any previous exposure to ecallantide;
- •22.Receipt of an investigational drug or device 30 days prior to participation in the current study;
- •23.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;
- •24.Inability to comply with the protocol for the duration of the study;
- •25.Known allergy to any agent expected to be used in the intra-operative or post-operative periods; and
- •26.Administration of:
- •a. Eptifibatide within 6 hours prior to surgery
- •b.Tirofiban hydrochloride within 6 hours prior to surgery
- •c.*Enoxaparin sodium or other low-molecular-weight heparin <24 hours prior to surgery
- •d.Prasugrel within 10 days prior to surgery
- •e.Clopidogrel within 3 days prior to surgery
- •f.Ticlopidine within 7 days prior to surgery
- •g.Abciximab within 5 days prior to surgery
- •h.*Bivalirudin, argatroban or lepirudin within 6 hours prior to surgery
- •i.*Fondaparinux within 72 hours prior to surgery
- •j.Chlorpromazine within 7 days prior to surgery
- •*Prophylactic use permitted for the prevention of deep vein thrombosis.
- •27.Planned use of heparin bonded bypass circuits;
- •28.Known allergy or hypersensitivity to tranexamic acid or any of the other ingredients;
- •29.Disturbance of color sense;
- •30.Evidence of hematuria or any acute thromboses or thromboembolic diseases such as deep vein thrombosis, pulmonary embolism, or vertebral vein thrombosis.
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