18 and older, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Biotin Labeled Red Blood CellsPrimary· 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.
Percentage of Fresh Biotin Labeled Red Blood Cells at 24 Hours
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
99.2
99.2 – 99.3
Percentage of Fresh Biotin Labeled Red Blood Cells at Day 30
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
77.2
74.7 – 79.6
Percentage of Fresh Biotin Labeled Red Blood Cells at Day 60
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
54.3
49.5 – 59.2
Percentage of Aged Biotin Labeled Red Blood Cells at 24 Hours
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
99.2
99.1 – 99.3
Percentage of Aged Biotin Labeled Red Blood Cells at Day 30
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
75.9
72.9 – 78.9
Percentage of Aged Biotin Labeled Red Blood Cells at Day 60
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
51.9
45.9 – 57.8
The Percentage of Storage HemolysisSecondary· 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. Quantification of storage hemolysis is based on this equation: (sample hematocrit x levels of free hemoglobin obtained after centrifugation measured in the supernatant / the total amount of sample hemoglobin before centrifugation) x 100.
5-7 days
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
0.27
± 0.09
35-42 days
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
0.21
± 0.14
The Percentage of Red Blood Cell Osmotic HemolysisSecondary· 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 percent osmotic hemolysis is determined by this equation: (supernatant cell-free hemoglobin of pink test-treated RBCs / total amount of hemoglobin) x 100.
5-7 days
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
7.4
± 4.66
35-42 days
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
7.9
± 6.86
The Percentage of Red Blood Cell Oxidative HemolysisSecondary· 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. The percent osmotic hemolysis is determined by this equation: (supernatant cell-free hemoglobin of 2,2'-azobis-2-methyl-propanimidamide, dihydrochloride treated RBCs - supernatant cell-free hemoglobin of untreated red blood cells / total amount of hemoglobin) x 100.
5-7 days
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
39.93
± 12.45
35-42 days
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
46.90
± 21.92
Length of Time Biotin-labeled Red Blood Cells Can be Detected Following InfusionSecondary· up to 165 days
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.
Fresh Stored Cells
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
135
± 12
Stored Cells
Group
Value
95% CI
Biotin-Labeled Red Blood Cells Infusion
104
± 12
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 125-150 post blood transfusion.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gladwin, Mark, MD
Last refreshed: 21 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03364686.