Biotin (vitamin B7) labeling of platelets to track their survival and recovery
BR-PROSPECT: Biotin and Radiolabeling for the Platelet Recovery, Survival, and Post-transfusion Evaluation of Changes
This study will try using biotin (vitamin B7) to label donated platelets so researchers can track how long they survive and recover in healthy volunteers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bloodworks Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT07513532 on ClinicalTrials.gov |
What this trial studies
Healthy adult donors will give platelets by apheresis and units will be labeled with biotin and stored for three days. On day 3 a small portion of the stored biotin-treated platelets will be radiolabeled and returned to the donor alongside a fresh radiolabeled platelet sample to compare recovery and survival. Serial blood draws over 12 days will measure circulating labeled platelets, function, metabolomics, and antibody coating, and participants will be followed for six months for platelet counts and antibody/biotin testing. The primary goal is to determine whether biotinylation yields equivalent in vivo recovery and survival results to standard radiolabeling for both fresh and 3-day stored platelets.
Who should consider this trial
Good fit: Healthy adults who meet Bloodworks Northwest autologous apheresis donor criteria, are not pregnant or lactating, and are off platelet-inhibiting medications for the required windows are ideal candidates.
Not a fit: People with significant medical conditions, recent participation in other trials, splenectomy, positive anti-biotin or antiplatelet antibodies, pregnancy, or recent use of aspirin or platelet-inhibiting drugs would not be expected to benefit or be eligible.
Why it matters
Potential benefit: If successful, biotin labeling could provide a non-radioactive way to track platelet survival that is safer and more convenient for donors and researchers.
How similar studies have performed: Prior smaller studies have used biotinylation as a non-radioactive platelet label with promising results, but direct head-to-head comparisons with radiolabeling are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seattle, Washington
- Bloodworks Northwest Research Institute — Seattle, Washington, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.