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 : April 23, 2018
|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 and Post-Transfusion Red Blood Cell Recovery|
|Estimated Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||June 30, 2023|
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 with specified genetic mutations, compared with control subjects without the specified mutation.
- 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.
- Number of Membrane microvesicle formation [ Time Frame: 5-7 days and 35-42 days following blood donation ]This will be quantified by centrifugation and collection of supernatants from stored red blood cell units.
- Percentage of biotin labeled red blood cells [ Time Frame: 24 hours following blood transfusion ]This will be determined as the percentage of biotin-labeled cells remaining in the circulation 24 hours after transfusion relative to the 20-minute post-infusion blood sample.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|