NCT02684474No Longer Available不适用
Expanded Access Protocol Using HBOC-201 to Treat Patients With Life Threatening Anemia, for Whom Blood is Not an Option
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom allogeneic blood transfusion is not an option. HBOC 201 [hemoglobin glutamer - 250 (bovine)] has been previously studied as an alternative to blood transfusions in severely anemic patients needing a way to enhance tissue oxygenation. HBOC-201 is purified, cross-linked and polymerized acellular bovine hemoglobin in a modified lactated Ringer's solution, and does not require blood compatibility.
研究设计
- 研究类型
- Expanded Access
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
- •Critically ill patients with hemoglobin ≤ 6 g/dL (or 7-8 g/dL with significant active bleeding), and physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or evidence of central nervous system acute deficits
- •Patients or their Legally Authorized Representative who are able and willing to provide informed consent
- •Blood is not an option due to:
- •refusal of transfusion
- •lack of compatible red blood cells
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*
- •Patients who are eligible for blood transfusions
- •Patients who are > 80 years old*
- •on a case by case and quality of life determination
研究者
研究点 (1)
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