EUCTR2005-003639-30-GB进行中（未招募）1 期
Enhancement of Tissue Preservation During Cardiopulmonary Bypasswith HemoPure®
Biopure Corporation0 个研究点目标入组 60 人开始时间: 2005年9月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •Candidates for this study must meet ALL of the following criteria:
- •Subject is between the ages of 18 and 85.
- •Subject is an acceptable candidate for CABG.
- •Subject is scheduled for CABG (with or without planned valvular repair or replacement) by cardiopulmonary bypass.
- •Subject signs informed consent
- •Subject and the treating physician agree that subject can comply with all study procedures and follow-up visits at time of subject screening.
- •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
- •Candidates will be excluded from this study if ANY of the following criteria are present:
- •Pre-operative myocardial infarction, defined as CK level > 2 times upper limit of site normal 24 hours prior to CABG surgery.
- •Renal failure defined as serum creatinine greater than 220 umol/L
- •Subject has an ejection fraction = 30% (as measured by Echocardiography within 30 days of study enrollment).
- •Active infection.
- •History of prior stroke within last six months or history of prior stroke with residual neurological deficit.
- •Transient Ischemic attack within last 6 months.
- •Subject has a history of coagulopathy.
- •Subject is pregnant or currently breastfeeding.
- •History of allergy to beef products.
- •Pre-operative cardiogenic shock defined as cardiac index = 1.8.mL/min/m2 despite the use of vassopressors.
- •Underlying medical conditions that would limit subject’s life expectancy to less than 12 months.
- •Severe pulmonary impairment (e.g., emphysema) that may interfere with weaning subject from ventilator.
- •History of acute central nervous disorder (e.g., seizure or traumatic injury).
- •Severe hypertension (160/90 mm Hg) that cannot be medically controlled despite treatment with two antihypertensive therapies.
- •Severe liver dysfunction as defined by total bilirubin = 51 umol/L or 2 times the site normal limit of AST or ALT activity.
- •Subject has systemic mastocytosis.
- •Subject has any condition that pre-disposes the subject to systemic mast cell degranulation or hypersensitivity reactions or a history of severe allergic reactions to drugs or environmental allergens.
- •Subject has participated in another investigational drug, biologic or device study within 30 days prior to study enrollment.
研究者
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