IMPROVE: Inactivation of Whole Blood With Mirasol (R): Performance in Red Blood Cells, Platelets and Plasma Investigation
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Red Blood Cell (RBC) Recovery
研究概览
简要总结
Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood
详细描述
Radiolabeling of red blood cells (RBCs) followed by infusion back to the donor is commonly used to test the quality of RBCs in a person. By measuring the level of radioisotope in a blood sample, these tests evaluate what percentage of the RBCs remain in the bloodstream after 24 hours (recovery) and can predict how long the RBCs will remain in circulation (survival). The IMPROVE trial is a feasibility trial to evaluate these parameters in RBCs obtained from whole blood units that have been treated with the Mirasol System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adults who meet AABB (formerly known as the American Association of Blood Banks) criteria for whole blood donation
- •females incapable of becoming pregnant
- •males agreeing to use contraception during trial
排除标准
- •pregnancy or nursing
- •abnormal medical history (bleeding disorders, anemia, myocardial ischemia, uncontrolled hypertension, heart disease, epilepsy)
- •major surgery
- •use of drugs affecting coagulation or RBC function
- •recent participation in other trials which may confound results
结局指标
主要结局
Red Blood Cell (RBC) Recovery
时间窗: 24-hour post autologous infusion of RBCs
The 24-hour recovery calculation was conducted to evaluate the percentage of labeled RBCs remaining in the circulation 24 hours after re-infusion of the cells, as compared to Time 0 measurements (time of re-infusion). FDA requires at least 75% recovery for new RBC processes.
次要结局
- Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival(28-days post autologous infusion of RBCs)
- Count of Participants With Serious Adverse Events (SAE)(28-days post autologous infusion of RBCs)