NCT03364686终止2 期
Transfusion of Biotin-Labeled Red Blood Cells for the Evaluation of Genetic Factors That Contribute to Donor Differences in Red Blood Cell Storage and Post-Transfusion Red Blood Cell Recovery
Gladwin, Mark, MD2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2019年9月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Percentage of Biotin Labeled Red Blood Cells
研究概览
简要总结
The purpose of this research is to evaluate the impact of genetic and biologic factors in blood donors on red blood cell storage stability after autologous transfusion over the different range of storage period of 5-7 days and 35-42 days in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Ages 18 years and older
- •Weight ≥110 lbs
- •Hemoglobin ≥ 12.5 g/dL or hematocrit ≥ 38% for women and hemoglobin ≥ 13.0 g/dL or hematocrit ≥ 39% for men.
- •Meet criteria for autologous blood donation
排除标准
- •Subjects with a past medical history or symptoms of blood dyscrasia, diabetes mellitus, hyperlipidemia, obstructive sleep apnea, renal disease, congestive heart failure, significant cardiac disease and / or known peripheral arterial disease.
- •Moderate to severe systemic hypertension (systolic blood pressure >140 mmHg and/or diastolic blood pressure > 95 mmHg
- •Systolic blood pressure <100 mmHg and/or diastolic blood pressure < 60 mmHg on the study day.
- •Positive Direct Antiglobulin Test
- •Consumption of biotin supplements or raw eggs within 30 days
- •Treatment with antibiotics in the week before initiating study participation to avoid suppression of erythropoiesis, which may accompany infection.
- •Blood loss in the previous 8 weeks due to epistaxis, trauma, hemoptysis, gastrointestinal bleeding, diagnostic phlebotomy (> 30 ml)
- •Subjects who report tobacco or marijuana smoking within 6 months of study.
- •Cognitively impaired subjects, or institutionalized persons and subjects unable or unwilling to complete written informed consent
- •Subjects with a history of blood donation within the last 56 days.
- •Use of other investigational drugs/devices within 30 days of screening.
- •Subjects taking any medication for the treatment of diabetes including insulin
- •Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with positive pregnancy testing on screening day will be excluded.
- •History of prior transfusion reaction to blood products.
- •Allergic reaction to biotin
- •Donors with naturally occurring antibodies against BioRBCs will be excluded from the study
结局指标
主要结局
Percentage of Biotin Labeled Red Blood Cells
时间窗: 24 hours, 30 days and 60 days after transfusion
This will be determined using enumeration of biotinylated red blood cells obtained by flow cytometry from blood samples obtained at various time points from subjects with specified genetic mutations, compared with control subjects without the specified mutation. Percentage of Biotin Labeled Red Blood Cells is determined by Biotin Labeled Red Blood Cells in circulation at each time point/baseline Biotin Labeled Red Blood Cells in circulation x 100.
次要结局
- The Percentage of Red Blood Cell Oxidative Hemolysis(5-7 days and 35-42 days following blood donation)
- The Percentage of Red Blood Cell Osmotic Hemolysis(5-7 days and 35-42 days following blood donation)
- The Percentage of Storage Hemolysis(5-7 days and 35-42 days following blood donation)
研究者
Darrell Triulzi MD
Professor
University of Pittsburgh
研究点 (2)
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