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This is a platelet transfusion study. The primary purpose of this study is to determine if Biotin, vitamin B7 is an effective way to label platelets in survival and recovery studies. This study involves using a radioactive material as well as Biotin added to platelets to track platelets in the blood. The platelets will be collected using an apheresis procedure, labeled with biotin, and stored for 3 days. After the storage period, a radioactive material will be added to a small amount of the stored biotin-treated platelets. The radiolabeled platelets will be given back to donor and follow-up blood draws will be done to see how many of the platelets are circulating.
To evaluate the hypothesis that biotinylation of platelets stored at room temperature for 3 days is equivalent for the assessment of in vivo recovery and survival to radiolabeled platelets. The post-transfusion recovery and survival of autologous biotinylated 3-day platelets will be measured in comparison with those of autologous radiolabeled 3-day platelets from the same source. In the same fashion, "fresh" autologous biotinylated platelets, will be compared to "fresh" radiolabeled platelets according to Food and Drug Administration, FDA guidance for platelet testing.
Healthy volunteers will be asked to donate a platelet unit, which will be stored for 3 days. On the day of radiolabeling, the investigators will collect samples for metabolomics and functional assessment. The volunteers will return on day 3 and receive a radiolabeled and biotinylated aliquot of the stored unit, as well as a fresh radiolabeled platelet aliquot. The investigators will collect blood samples over the following 12 days to determine recovery, survival, function, metabolomic changes, and antibody coating of the stored platelets. During a 6-month follow-up period, the investigators will collect samples for platelet count, biotin, and platelet antibody detection, and biotin levels if antibodies are present at 1, 3, and 6 months to exclude harmful effects of the biotin-labeled platelets on healthy individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biotin labeled platelets | Experimental | Donor platelets labeled with biotin, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotin labeled platelets | Biological | Biotin labeled platelets stored at room temperature for 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint Recovery and Survival | Post-transfusion recovery and survival of biotinylated platelets will be assessed using flow cytometry. | 12 days post infusion |
| Primary Endpoint Recovery and Survival | Post-transfusion recovery and survival of biotinylated platelets will be assessed using platelet levels. | 12 days post infusion |
| Primary Endpoint Recovery and Survival | Post-transfusion recovery and survival of biotinylated platelets will be assessed using blood gas values | 12 days post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint Platelet function | Platelet function markers will be assessed using flow cytometry. | 12 days post infusion |
| Secondary Endpoint Platelet function | Platelet function markers will be assessed using platelet levels |
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Inclusion Criteria:
Normal health status Meet Bloodworks Northwest guidelines for autologous apheresis platelet donation Screening chemistry/hematology lab results within normal limits negative blood donor screening panel for HIV, Hepatitis B and hepatitis C agreeable to birth control measures during the study.
Exclusion Criteria:
Clinically significant acute or chronic disease Pregnant or lactating females Participation in a clinical research study within 30 days of the platelet collection Treatment with aspirin-containing meds within 7 days of platelet collection Treatment with platelet-inhibiting meds within 14 days of platelet collection Splenectomized donor Presence of anti-biotin or antiplatelet antibody at screening
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bloodworks Northwest Research Institute | Recruiting | Seattle | Washington | 98102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38757806 | Background | Bailey SL, Bochenek M, Chauhan A, Miller B, Stolla M. Biotin labeling allows for post-transfusion functional assessment of stored human platelets in mice. Transfusion. 2024 Jul;64(7):1306-1314. doi: 10.1111/trf.17879. Epub 2024 May 17. | |
| 19319844 | Background | Zempleni J, Wijeratne SS, Hassan YI. Biotin. Biofactors. 2009 Jan-Feb;35(1):36-46. doi: 10.1002/biof.8. |
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Up to 18 participants to achieve a total of 12 participants with evaluable stored biotinylated and radiolabeled and fresh radiolabeled recovery and survival data.
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| 12 days post infusion |
| Secondary Endpoint Platelet function | Platelet function markers will be assessed using blood gas values | 12 days post infusion |
| Secondary Endpoint Platelet function | Platelet function markers will be assessed using glucose values | 12 days post infusion |
| Secondary Endpoint Platelet function | Platelet function markers will be assessed using lactate values | 12 days post infusion |
| Secondary Endpoint Metabolomic markers | Metabolomic Markers will be measured using mass spectroscopy. | 12 days post infusion |
| Secondary Endpoint Antibody coating | Antibody coating of platelets | 6 months post infusion |
| 24969019 | Background | Mock DM, Widness JA, Veng-Pedersen P, Strauss RG, Cancelas JA, Cohen RM, Lindsell CJ, Franco RS. Measurement of posttransfusion red cell survival with the biotin label. Transfus Med Rev. 2014 Jul;28(3):114-25. doi: 10.1016/j.tmrv.2014.03.003. Epub 2014 Apr 5. |