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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL095479-06 | U.S. NIH Grant/Contract | View source | |
| P01HL086773-06A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this research is to study how red blood cells (RBCs) survive in a person's circulation, and how that survival may be different in red blood cells that are donated and stored prior to being transfused. Investigators will study this by collecting blood samples from participants, "labeling" RBCs with a naturally occurring vitamin, biotin. The RBCs will then be re-infused back into the participant and blood samples will be taken weekly for 10 weeks to assess the number of labeled cells in the samples.
The purpose of this research is to study how red blood cells (RBCs) survive in a person's circulation, and how that survival may be different in red blood cells that are donated and stored prior to being transfused.
In this study, blood is collected from healthy subjects, processed into packed red blood cell units, and either immediately afterwards or 40-42 days later the packed red blood cells are labeled with biotin. The biotin-labeled red blood cells are then re-infused back to the donor (autologous transfusion). Blood samples are then taken from the subject every week for up to 70 days (10 weeks) to track survival of the labeled red blood cells.
This study also seeks to demonstrate that biotin-labeled RBCs can be safely transfused back to autologous subjects without any adverse reactions. All participants will be followed to watch for the development of antibodies against biotin-labeled RBCs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biotin-Labeled Red Blood Cell (RBC) Infusion | Experimental | Blood will be drawn from participants and labeled with biotin before being re-infused back to the participant. Blood samples will be obtained weekly over 10 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotin-Labeled Red Blood Cells (RBCs) | Drug | 500 mL of blood will be drawn from each participant. The blood will be processed into a packed RBC unit. For participants 1 and 2, the RBCs will be labeled with biotin at three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and the labeled RBCs will be re-infused into the participant on the same day of collection. For participants 3 through 8, the RBCs will be stored at 2-6 C for 40-42 days before being labeled with three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and re-infused into the participant. Participants will have a 5 mL blood sample drawn within a few minutes of the re-infusion, the day after the re-infusion and then weekly for 70 days (10 weeks) to track the survival of the infused biotin labeled RBCs. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Had bRBC Detectable at 70 Days Post-intervention | The length of time biotin-labeled RBCs can be detected following re-infusion. The number of participants was determined at day 70 by taking blood samples from each of them | 70 days post-intervention |
| Length of Time Differentially Labeled Biotin-labeled RBCs Can be Distinguished From One Another | The length of time that the three different concentrations of biotin labeling on the RBCs can be distinguished from one another will be determined by taking blood samples from each participant for 70 days | Up to 112 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | The total number of participants who experience adverse events, including development of anti-biotin-RBC antibodies will be determined. In previous studies, antibodies for biotin-labeled RBCs have been seen in a small number of people for up to 12 months. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John D Roback, MD, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biotin-Labeled Red Blood Cell (RBC) Infusion | Blood will be drawn from participants and labeled with biotin before being re-infused back to the participant. Blood samples will be obtained weekly over 10 weeks. Biotin-Labeled Red Blood Cells (RBCs): 500 mL of blood will be drawn from each participant. The blood will be processed into a packed RBC unit. For participants 1 and 2, the RBCs will be labeled with biotin at three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and the labeled RBCs will be re-infused into the participant on the same day of collection. For participants enrolled after the first two participants, the RBCs will be stored at 2-6 C for 40-42 days before being labeled with three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and re-infused into the participant. Participants will have a 5 mL blood sample drawn within a few minutes of the re-infusion, the day after the re-infusion and then weekly for 70 days (10 weeks) to track the survival of the infused biotin labeled RBCs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Biotin-Labeled Red Blood Cell (RBC) Infusion | Blood will be drawn from participants and labeled with biotin before being re-infused back to the participant. Blood samples will be obtained weekly over 10 weeks. Biotin-Labeled Red Blood Cells (RBCs): 500 mL of blood will be drawn from each participant. The blood will be processed into a packed RBC unit. For participants 1 and 2, the RBCs will be labeled with biotin at three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and the labeled RBCs will be re-infused into the participant on the same day of collection. For participants enrolled after the first two participants, the RBCs will be stored at 2-6 C for 40-42 days before being labeled with three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and re-infused into the participant. Participants will have a 5 mL blood sample drawn within a few minutes of the re-infusion, the day after the re-infusion and then weekly for 70 days (10 weeks) to track the survival of the infused biotin labeled RBCs. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Had bRBC Detectable at 70 Days Post-intervention | The length of time biotin-labeled RBCs can be detected following re-infusion. The number of participants was determined at day 70 by taking blood samples from each of them | Posted | Number | participants | 70 days post-intervention |
|
Up to 12 months after infusion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biotin-Labeled Red Blood Cell (RBC) Infusion | Blood will be drawn from participants and labeled with biotin before being re-infused back to the participant. Blood samples will be obtained weekly over 10 weeks. Biotin-Labeled Red Blood Cells (RBCs): 500 mL of blood will be drawn from each participant. The blood will be processed into a packed RBC unit. For participants 1 and 2, the RBCs will be labeled with biotin at three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and the labeled RBCs will be re-infused into the participant on the same day of collection. For participants 3 through 5, the RBCs will be stored at 2-6 C for 40-42 days before being labeled with three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and re-infused into the participant. Participants will have a 5 mL blood sample drawn within a few minutes of the re-infusion, the day after the re-infusion and then weekly for 70 days (10 weeks) to track the survival of the infused biotin labeled RBCs. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Roback | Emory University | 404-712-1774 | jroback@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2018 | Mar 30, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2023 | Apr 21, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Length of Time Differentially Labeled Biotin-labeled RBCs Can be Distinguished From One Another | The length of time that the three different concentrations of biotin labeling on the RBCs can be distinguished from one another will be determined by taking blood samples from each participant for 70 days | For technical reasons, the investigators could not effectively label multiple red cell populations with different concentrations of biotin and this outcome was not collected. | Posted | Up to 112 days |
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| Secondary | Number of Participants Experiencing Adverse Events | The total number of participants who experience adverse events, including development of anti-biotin-RBC antibodies will be determined. In previous studies, antibodies for biotin-labeled RBCs have been seen in a small number of people for up to 12 months. | Posted | Count of Participants | Participants | Up to 12 months |
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| 5 |
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| 5 |
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