protocolSection identificationModule nctId: NCT06313398, orgStudyIdInfo id: 10001883, secondaryIdInfos id: 001883-H, briefTitle: Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-05-01, completionDateStruct date: 2029-06-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Heart, Lung, and Blood Institute (NHLBI), class: NIH, collaborators name: Children's National Research Institute, descriptionModule briefSummary: Background:Sickle cell disease (SCD) is an inherited disorder of the blood. SCD causes red blood cells (RBCs) to die early. This can lead to a shortage of healthy cells. SCD and other blood disorders can be managed with drugs or cured with a bone marrow transplant. Researchers want to know how long RBCs survive in people with SCD and other blood disorders before and after treatment compared to those who had a bone marrow transplant.Objective:To learn how long RBCs survive in the body in people with SCD and other blood disorders compared to those whose disease was cured with a bone marrow transplant.Eligibility:People aged 18 years or older with SCD or another inherited blood disorder. People whose SCD or blood disorder was cured with a bone marrow transplant are also needed.Design:Participants will be screened. They will have a physical exam with blood and urine tests.Participants will have about 7 tablespoons of blood drawn. In the lab, this blood will be mixed with a vitamin called biotin. Biotin sticks to the outside of RBCs. This process is called "biotin labeling of RBCs." The next day, the participant s own biotin-labeled RBCs will be returned to their bloodstream.Participants will return regularly to have smaller blood samples (about 2 teaspoons) drawn. These samples will be tested to detect the percentage of cells that have biotin labels. These visits may be every 2 weeks, 4 weeks, or some other interval. Participants will continue this schedule for up to 20 weeks or until biotin can no longer be detected...., conditionsModule conditions: Sickle Cell Disease, conditions: Thalassemia, conditions: Hemoglobinopathy, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Biotin-labeled red blood cells, outcomesModule primaryOutcomes measure: To determine and compare red blood cell survival, by virtue of the mean number of days of detectable biotin-labeled RBCs, in participants with SCD and/or other hemoglobinopathies., secondaryOutcomes measure: Validate the association of RBC survival with known markers of increased survival., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, status: RECRUITING, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: NIH Clinical Center Office of Patient Recruitment (OPR), role: CONTACT, phone: 800-411-1222, phoneExt: TTY dial 711, email: ccopr@nih.gov, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False