Trial Outcomes & Findings for Transfusion of Biotinylated Red Blood Cells (NCT NCT02757898)
NCT ID: NCT02757898
Last Updated: 2023-05-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
70 days post-intervention
Results posted on
2023-05-09
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transfusion of Biotinylated Red Blood Cells
Baseline characteristics by cohort
| Measure |
Biotin-Labeled Red Blood Cell (RBC) Infusion
n=5 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 70 days post-interventionThe 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
Outcome measures
| Measure |
Biotin-Labeled Red Blood Cell (RBC) Infusion
n=5 Participants
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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|---|---|
|
Number of Participants That Had bRBC Detectable at 70 Days Post-intervention
|
5 participants
|
PRIMARY outcome
Timeframe: Up to 112 daysPopulation: For technical reasons, the investigators could not effectively label multiple red cell populations with different concentrations of biotin and this outcome was not collected.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsThe 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.
Outcome measures
| Measure |
Biotin-Labeled Red Blood Cell (RBC) Infusion
n=5 Participants
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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|---|---|
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Number of Participants Experiencing Adverse Events
|
0 Participants
|
Adverse Events
Biotin-Labeled Red Blood Cell (RBC) Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place