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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL098032-09 | U.S. NIH Grant/Contract | View source |
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Due to enrollment challenges related to COVID and lack of coordinator support
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biotin-Labeled Red Blood Cells Infusion | Experimental | Each participant will receive 2 transfusions of biotin labeled red blood cells. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotin-Labeled Red Blood Cells | Biological | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Biotin Labeled Red Blood Cells | 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. | 24 hours, 30 days and 60 days after transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Storage Hemolysis | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darrell Triulzi, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biotin-Labeled Red Blood Cells Infusion | Each participant will receive 2 transfusions of biotin labeled red blood cells. 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Biotin-Labeled Red Blood Cells Infusion | Each participant will receive 2 transfusions of biotin labeled red blood cells. 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). |
| 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 | Percentage of Biotin Labeled Red Blood Cells | 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. | The blood sample at 24 hours from one of the 4 completed subjects was not collected. | Posted | Mean | 95% Confidence Interval | percentage of biotin labeled RBC | 24 hours, 30 days and 60 days after transfusion |
|
Day 125-150 post blood transfusion
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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 Cells Infusion | Each participant will receive 2 transfusions of biotin labeled red blood cells. 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weakly positive antibodies | Blood and lymphatic system disorders | CTCAE 4.0 | Non-systematic Assessment | Subject developed transient antibiotin antibodies without evidence of hemolysis. The test was weakly positive at Visit 8 and was undetected at Visit 10. |
The clinical trial was terminated early due to challenges with enrollment and lack of study coordinator support. Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Darrell J. Triulzi, MD | University of Pittsburgh | 412-209-7304 | triudj@upmc.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 | Apr 30, 2021 | Jan 11, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2021 | Jan 11, 2022 | ICF_001.pdf |
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| 5-7 days and 35-42 days following blood donation |
| The Percentage of Red Blood Cell Osmotic Hemolysis | 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 and 35-42 days following blood donation |
| The Percentage of Red Blood Cell Oxidative Hemolysis | 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 and 35-42 days following blood donation |
| 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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| Secondary | The Percentage of Storage Hemolysis | 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. | Posted | Mean | Standard Deviation | percentage of storage hemolysis | 5-7 days and 35-42 days following blood donation |
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| Secondary | The Percentage of Red Blood Cell Osmotic Hemolysis | 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. | Posted | Mean | Standard Deviation | percentage of osmotic hemolysis | 5-7 days and 35-42 days following blood donation |
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| Secondary | The Percentage of Red Blood Cell Oxidative Hemolysis | 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. | Posted | Mean | Standard Deviation | percentage of oxidative hemolysis | 5-7 days and 35-42 days following blood donation |
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| Post-Hoc | Length of Time Biotin-labeled Red Blood Cells Can be Detected Following Infusion | 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. | The fresh stored blood sample from one participant was not collected and analyzed. | Posted | Mean | Standard Deviation | days | up to 165 days |
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| 6 |
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