NCT02118428已完成不适用
AIMS Study: African Investigation of Mirasol System for Whole Blood. Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria
Terumo BCTbio1 个研究点 分布在 1 个国家目标入组 227 人开始时间: 2014年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Incidence of Transfusion-transmitted Malaria
研究概览
简要总结
The trial will evaluate the efficacy of the Mirasol Pathogen Reduction Technology for Whole Blood to prevent Malaria transmission by transfusion of whole blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patient is blood group O+
- •Anticipated to be hospitalized for at least 3 consecutive days after initial study transfusion
- •Expected to require no more than 2 units of Fresh Whole Blood in the 3 days following randomization
- •Agree to return to the hospital for the follow-up visits
- •Women of Child Bearing Potential must have a negative pregnancy test within 72 hours before randomization when warranted and must agree to practice a medically acceptable contraception regimen or agree to abstain from heterosexual intercourse during their study participation.
- •Patient or legally authorized representative has given written informed consent
排除标准
- •Symptoms of clinical malaria (confirmed by microscopy)
- •Patient has received antimalarial treatment within 7 days prior to randomization
- •Fever (Central body temperature greater than 38.5°C)
- •Massive bleeding expected to require more than two Fresh Whole Blood units within 3 days from randomization
- •Transfusion(s) of a blood product within 1 month prior to randomization
- •Acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the patient to receive protocol treatment
- •Previous treatment with other pathogen-reduced blood products
- •Females who are pregnant
研究组 & 干预措施
Mirasol
Experimental
Transfusions with Mirasol-treated whole blood
干预措施: Mirasol-treated Whole Blood (Device)
Control
Active Comparator
Transfusions with untreated whole blood
干预措施: Untreated Whole Blood (Biological)
结局指标
主要结局
Percentage of Participants With Incidence of Transfusion-transmitted Malaria
时间窗: Up to 28 (+4) days after the initial whole blood transfusion (measured within 24 hours prior to each transfusion and at 24 (± 4) hours, 2 days, 3 days, 7 (+1) days, and 28 (+4) days after the initial whole blood transfusion)
Percentage of Participants who contracted transfusion-transmitted malaria (TTM)
次要结局
- Bacterial Contamination of Fresh Whole Blood (FWB) Products(immediately post-blood product collection & within 7 days before transfusion, post-Mirasol treatment (within 24 hours post-blood product collection) & within 7 days before transfusion)
- Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin(Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion))
- Hematology Parameter in Patients - Hematocrit(Days 0, 1, 2, 3, 7, 28)
- Hematology Parameter in Patients - White Blood Cell (WBC) Count(Days 0, 1, 2, 3, 7, 28)
- Coagulation Parameter in Patients - Prothrombin Time(Days 0, 1, 2, 3)
- Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit(Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion))
- Hematology Parameter in Fresh Whole Blood Products - Platelet Count(Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion))
- Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count(Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion))
- Hematology Parameter in Patients - Red Blood Cell (RBC) Count(Days 0, 1, 2, 3, 7, 28)
- Biochemistry Parameter in Patients - Potassium(Days 0, 1, 2, 3)
- Coagulation Parameter in Patients - International Normalized Ratio (INR)(Days 0, 1, 2, 3)
- Hematology Parameter in Patients - Platelet Count(Days 0, 1, 2, 3, 7, 28)
- Hematology Parameter in Patients - Total Hemoglobin(Days 0, 1, 2, 3, 7, 28)
- Coagulation Parameter in Patients - Activated Partial Thromboplastin Time(Days 0, 1, 2, 3)
- Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count(Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion))
- Biochemistry Parameter in Fresh Whole Blood Products - Potassium(Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion))
研究者
研究点 (1)
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