Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HL148151-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Funding not renewed
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Columbia University | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
This study will address if red blood cells transfused to a sickle cell patient from a donor with a glucose-6-phosphate-dehydrogenase (G6PD) enzyme deficiency have a different lifespan as measured by the percentage of red blood cells that survive post-transfusion compared to red blood cells transfused to a sickle cell patient from a donor without a G6PD enzyme deficiency.
This prospective, phase II, crossover, single-blind, randomized transfusion order study will address if red blood cells from donors with a G6PD enzyme deficiency have a different lifespan once transfused into a patient with sickle cell disease than red blood cells from an otherwise normal donor. Results of this critical study will guide future research and donor testing policies to ensure that patients receive the most appropriate units of blood for their condition. Each patient randomized to the study will receive 2 blood transfusions, one from a G6PD deficient donor and one from an otherwise normal donor. Half the patients (8) will receive G6PD deficient blood first while the other half (8) will receive non-G6PD deficient blood first. Patients will have a wash-out period of at least 4 months before receiving the opposite type of blood transfusion. The blood transfusion order will be randomized. There is currently no standard of testing in place to screen blood donations for G6PD enzyme deficiency. It is believed that up to 10% of the antigen-matched donors for patients with sickle cell disease are G6PD deficient, and the lifespan is unknown in the sickle cell population.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G6PD Deficient Red Blood Cell Transfusion, then Non-G6PD deficient Red Blood Cell Transfusion | Experimental | Transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity. |
|
| Non-G6PD deficient Red Blood Cell Transfusion, then G6PD Deficient Red Blood Cell Transfusion, | Active Comparator | Transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G6PD Deficient Red Blood Cell Transfusion | Biological | Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Red Blood Cells Surviving | Post-Transfusion Recovery | 24 hours post-transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Hemoglobin A | Hemoglobin A | 1 hour post-transfusion, 4 weeks post-transfusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew Karafin, MD, MS | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
9 to 36 months following publication
Investigator proposing to use the data has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | G6PD Deficient Red Blood Cell Transfusion, Then Non-G6PD Deficient Red Blood Cell Transfusion | Transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in glucose-6-phosphate-dehydrogenase (G6PD) enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity. G6PD Deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient. Non-G6PD deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient. |
| FG001 | Non-G6PD Deficient Red Blood Cell Transfusion, Then G6PD Deficient Red Blood Cell Transfusion, | Transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity G6PD Deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient. Non-G6PD deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Intervention |
| |||||||||||||
| Washout (4 Months) |
| |||||||||||||
| Second Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | G6PD Deficient Red Blood Cell Transfusion, Then Non-G6PD Deficient Red Blood Cell Transfusion | Transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity. G6PD Deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient. Non-G6PD deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Red Blood Cells Surviving | Post-Transfusion Recovery | Posted | Mean | Standard Deviation | percentage of surviving red cells | 24 hours post-transfusion |
|
From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | G6PD Deficient Red Blood Cell Transfusion | Transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity. G6PD Deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shortness of Breath due to Heart Palpitations | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew S. Karafin MD MS | University of North Carollina at Chapel Hill | 984-974-1583 | matthew.karafin@unchealth.unc.edu |
Not provided
| 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 | Jan 12, 2023 | May 15, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 12, 2023 | Oct 30, 2024 | ICF_000.pdf |
Not provided
Not provided
Not provided
Not provided
Patients will not be told which type of blood they are receiving first. There is no way to tell if blood has enzyme deficiencies by looking at it.
| Non-G6PD deficient Red Blood Cell Transfusion | Biological | Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient. |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Non-G6PD Deficient Red Blood Cell Transfusion, Then G6PD Deficient Red Blood Cell Transfusion, | Transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity G6PD Deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient. Non-G6PD deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Mean Percent Change in Hemoglobin A | Hemoglobin A | Posted | Mean | Standard Deviation | Percentage of Hemoglobin A | 1 hour post-transfusion, 4 weeks post-transfusion |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Non-G6PD Deficient Red Blood Cell Transfusion | Transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity. Non-G6PD deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient. | 0 | 5 | 0 | 5 | 1 | 5 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Stuffy Nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinus Headache | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided