Healthy Volunteers
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALBiotin labeled platelets
Biotin labeled platelets stored at room temperature for 3 days.
Sponsors
Bloodworks
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Up to 18 participants to achieve a total of 12 participants with evaluable stored biotinylated and radiolabeled and fresh radiolabeled recovery and survival data.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint Recovery and Survival | 12 days post infusion | Post-transfusion recovery and survival of biotinylated platelets will be assessed using flow cytometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint Platelet function | 12 days post infusion | Platelet function markers will be assessed using flow cytometry. |
| Secondary Endpoint Metabolomic markers | 12 days post infusion | Metabolomic Markers will be measured using mass spectroscopy. |
| Secondary Endpoint Antibody coating | 6 months post infusion | Antibody coating of platelets |
Countries
United States
Outcome results
None listed