Transfusion of Biotin-Labeled Red Blood Cells
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|ClinicalTrials.gov Identifier: NCT03364686|
Recruitment Status : Not yet recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Biological: Biotin-Labeled Red Blood Cells||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Transfusion of Biotin-Labeled Red Blood Cells for the Evaluation of Genetic Factors That Contribute to Donor Differences in Red Blood Cell Storage Outcomes|
|Anticipated Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||June 30, 2023|
Experimental: Experimental - Biotin-Labeled Red Blood Cells Infusion
Each participant will receive 2 transfusions of biotin labeled red blood cells.
Biological: Biotin-Labeled Red Blood Cells
We will collect 500 mL of blood. The blood will be processed and split into two bags and labeled with a naturally occurring vitamin, biotin. The blood will then be re-infused back into the same participant at 2 time points (5-7 days and 35-42 days after storage).
- Length of time biotin-labeled RBCs can be detected following infusion [ Time Frame: up to 165 days ]This will be determined using enumeration of biotinylated RBCs obtained by flow cytometry from blood samples obtained at various time points from subjects.
- The percentage of storage hemolysis [ Time Frame: 5-7 days and 35-42 days following blood donation ]This will be quantified as percent hemolysis, which accounts for the levels of RBC-derived free hemoglobin in response to cold storage. We will define the associations between the primary endpoints and the quantification of storage hemolysis.
- The percentage of red blood cell osmotic hemolysis [ Time Frame: 5-7 days and 35-42 days following blood donation ]This will be quantified by the evaluation of osmotic stress assays. We will define the associations between the primary endpoints and the quantification of osmotic hemolysis.
- The percentage of red blood cell oxidative hemolysis [ Time Frame: 5-7 days and 35-42 days following blood donation ]This will be quantified by the evaluation of oxidative stress assays. We will define the associations between the primary endpoints and the quantification of oxidative hemolysis.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364686
|Contact: Nicole Helbling, RN, BSN, MSfirstname.lastname@example.org|
|Principal Investigator:||Michael Risbano, MD||University of Pittsburgh|