Expanded Access Protocol for the Treatment Use of HBOC-201
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- survival
研究概览
简要总结
The purpose of this expanded access study is to be able to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option.
HBOC-201 is not FDA approved for use in the United States, but is approved as an oxygen carrier in South Africa and Russia.
详细描述
i. Initial Dose
For patients with a hemoglobin level less than 6 mg/dl, an initial dose of 32.5 g (one unit) of HBOC 201 is recommended, to be followed by infusion of additional units as necessary to achieve and maintain a total hemoglobin concentration above 6 g/dl, provided that the patient's circulatory volume is properly controlled and will not impose an inappropriate risk.
ii. Subsequent Doses
The need for additional dose administration should be assessed after each infusion as clinically indicated.
Dosing will be stopped if any one of the following occurs:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients > = 18 years of age
- •Patients with hemoglobin < = 8g/dL with with active bleeding, physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or central nervous system supply dependency
- •Patients or their Legally Authorized Representatives who are able and willing to provide informed consent
排除标准
- •Patients with known hypersensitivity or allergy to beef products
- •Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis (on a case by case and quality of life determination)
- •Patients > 80 years of age (on a case by case and quality of life determination)
- •Patients who are eligible for blood transfusions
研究组 & 干预措施
All subjects
all qualifying subjects will receive HBOC-201 (Hemopure) to treat their life-threatening anemia
干预措施: HBOC-201 (Biological)
结局指标
主要结局
survival
时间窗: 1 week
subjects will receive HBOC-201 to treat life-threatening anemia
次要结局
未报告次要终点