NL-OMON56734招募中不适用
An In Vivo 24-Hour Recovery Study of Leukoreduced RBCs After Automated Separation of Whole Blood by the Reveos System and Storage With Non-DEHP Disposables. - HYBRID-study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Terumo
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational invasive
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Inclusion criteria for participant selection:
- •1. Healthy volunteers
- •2. Age >= 18 years < 60 years
- •3. Normal health status as per Sanquin National Blood Bank criteria for healthy
- •4. Able to commit to the study schedule
- •5. Participants of childbearing potential must agree to use a medically
- •acceptable method of contraception throughout of the study
- •6. Participants of childbearing potential must be willing to take a pregnancy
- •test prior to WB donation
- •7. Signed and dated informed consent form within 30 days of the Day 0 visit
排除标准
- •Exclusion criteria for participant selection:
- •1. Pregnant or nursing females
- •2. Serum ferritin <12 ng/mL
- •3. Has previously completed this study with evaluable data points
- •4. Participation currently, or within the past 30 days, in another
- •investigational trial that would potentially interfere with the analysis of
- •this investigation (e.g. pharmaceutical)
- •5. Participants who are deferred from volunteer community donations as per
- •Sanquin National Blood Bank criteria for healthy donors
- •6. As determined by the Investigator a. Has been diagnosed with a blood
- •disorder(s) affecting RBC characteristics (e.g. G6PD deficiency). b. Reported
- •history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies
- •c. Clinically significant acute or chronic disease d. Reported history or known
- •hypersensitivity to biotin and iodine e. Treatment with any medication as
- •specified in site deferral list f. Current drug use g. Currently abusing
- •alcohol. Alcohol abuse is defined for men, consuming more than 4 drinks on any
- •day or more than 14 drinks per week and for women, consuming more than 3 drinks
- •on any day or more than 7 drinks per week
- •7. Previously transfused with RBCs within the last 120 days
- •8. A positive biotin antibody test if they have received any biotin labeled
- •blood products in the past
- •9. Blood loss of more than 500 mL < 3 months, including blood donation
- •10. Other unspecified reasons that, in the opinion of the investigator make the
- •subject unsuitable for enrollment
研究者
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