NCT00301535Unknown2 期
Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study)
Biopure Corporation3 个研究点 分布在 3 个国家目标入组 60 人开始时间: 2006年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Rate of peak CK-MB elevation ≥ 5X upper limit of normal
研究概览
简要总结
The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.
详细描述
The primary objective is to determine the safety and feasibility of administering Hemopure® (HBOC-201) to reduce myocardial necrosis, as measured by CK-MB enzyme elevation, and enhance tissue preservation during cardiopulmonary bypass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between the ages of 18 and
- •Subject is an acceptable candidate for CABG.
- •Subject is scheduled for CABG (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 visit at time of subject screening.
排除标准
- •Pre-operative myocardial infarction, defined as CK-MB level > 2 times upper limit of normal 24 hours prior to CABG surgery.
- •Renal failure defined as serum creatinine greater 220 µmol/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.L/min/m2 despite the use of vasopressors.
- •Underlying medical conditions that would limit subject's life expectancy to less than 12 months.
- •Severe pulmonary disease [based upon clinical diagnosis or pulmonary function tests (FEV <1 liter), if available] 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 µmol/L or 2 times the site normal limit of AST or ALT activity.
- •Subject has systemic mastocytosis.
- •Subject has any condition that predisposes 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.
研究组 & 干预措施
1
Experimental
干预措施: HBOC-201 (hemoglobin glutamer-250 bovine) (Drug)
结局指标
主要结局
Rate of peak CK-MB elevation ≥ 5X upper limit of normal
时间窗: Baseline; Peri-op; Days 1,2,3 post procedure; Discharge or Day 6 post procedure(whichever is earlier)
次要结局
- MACE @ discharge and 30 days post surgery; Change in renal function; Renal failure; Increased Cardiac Troponin T; Death rate; MI/stroke; Supplemental RBC transfusions; Total units RBC and HBOC-201; Intra Aortic Balloon Pump use, pump time; New onset CHF(Duration of the study)
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
1 期
Enhancement of Tissue Preservation During Cardiopulmonary Bypasswith HemoPure®EUCTR2005-003639-30-GBBiopure Corporation60
进行中（未招募）
不适用
XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)Failure, Heart TransplantHeart FailureNCT05881278XVIVO Perfusion141
已完成
不适用
Cardioprotective Effects of Endogenous Erythropoietin in Patients Undergoing Coronary Artery Bypass SurgeryCardiac SurgeryNCT00854217Cliniques universitaires Saint-Luc- Université Catholique de Louvain40
招募中
不适用
Haemoadsorption During Heart TransplantationHeart TransplantationNCT05270902Medical University of Vienna40
终止
2 期
Study of Albumin to Reduce Inflammation Following SurgeryCardiopulmonary BypassSystemic Inflammatory Response SyndromeNCT00773110Imperial College London232