Healthy VolunteersPhase 1NCT07513532
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.
A Phase 1 study testing Biotin labeled platelets in people with Healthy Volunteers, run by Bloodworks at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Biotin labeled platelets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2026to 10 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Bloodworks Northwest Research Institute
Seattle, Washington, 98102
About this study
Official title: BR-PROSPECT: Biotin and Radiolabeling for the Platelet Recovery, Survival, and Post-transfusion Evaluation of Changes
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Biotin labeled platelets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biotin labeled plateletsBiological
Biotin labeled platelets stored at room temperature for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Biotin labeled platelets | Experimental | Donor platelets labeled with biotin, Receives: Biological: Biotin labeled platelets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint Recovery and Survival
Post-transfusion recovery and survival of biotinylated platelets will be assessed using flow cytometry.
Measured: 12 days post infusion
Primary Endpoint Recovery and Survival
Post-transfusion recovery and survival of biotinylated platelets will be assessed using platelet levels.
Measured: 12 days post infusion
Primary Endpoint Recovery and Survival
Post-transfusion recovery and survival of biotinylated platelets will be assessed using blood gas values
Measured: 12 days post infusion
Secondary outcomes (7)
Secondary Endpoint Platelet function
Platelet function markers will be assessed using flow cytometry.
Measured: 12 days post infusion
Secondary Endpoint Platelet function
Platelet function markers will be assessed using platelet levels
Measured: 12 days post infusion
Secondary Endpoint Platelet function
Platelet function markers will be assessed using blood gas values
Measured: 12 days post infusion
Secondary Endpoint Platelet function
Platelet function markers will be assessed using glucose values
Measured: 12 days post infusion
Secondary Endpoint Platelet function
Platelet function markers will be assessed using lactate values
Measured: 12 days post infusion
Secondary Endpoint Metabolomic markers
Metabolomic Markers will be measured using mass spectroscopy.
Measured: 12 days post infusion
Secondary Endpoint Antibody coating
Antibody coating of platelets
Measured: 6 months post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start6 Apr 2026
- Primary completion10 Jul 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bloodworks
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513532
- Sponsor's protocol ID
- BR-PROSPECT 1.0
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38757806Zempleni J, Wijeratne SS, Hassan YI. Biotin. Biofactors. 2009 Jan-Feb;35(1):36-46. doi: 10.1002/biof.8.
PubMed 19319844Mock 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.
PubMed 24969019
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BR-PROSPECT: Biotin and Radiolabeling for the Platelet Recovery, Survival, and Post-transfusion Evaluation of Changes
- ClinicalTrials.gov ID
- NCT07513532
- Acronym / sponsor ID
- BR-PROSPECT 1.0
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- BloodworksUniversity, hospital or other
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Biotin labeled platelets | Experimental | Biological: Biotin labeled plateletsDonor platelets labeled with biotin, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biotin labeled plateletsBiotin labeled platelets stored at room temperature for 3 days. | Biological | Biotin labeled platelets |
Primary outcome
Primary Endpoint Recovery and Survival
Time frame: 12 days post infusion
Post-transfusion recovery and survival of biotinylated platelets will be assessed using flow cytometry.
Primary Endpoint Recovery and Survival
Time frame: 12 days post infusion
Post-transfusion recovery and survival of biotinylated platelets will be assessed using platelet levels.
Primary Endpoint Recovery and Survival
Time frame: 12 days post infusion
Post-transfusion recovery and survival of biotinylated platelets will be assessed using blood gas values
7 secondary outcomes
Secondary Endpoint Platelet function
Time frame: 12 days post infusion
Secondary Endpoint Platelet function
Time frame: 12 days post infusion
Secondary Endpoint Platelet function
Time frame: 12 days post infusion
Secondary Endpoint Platelet function
Time frame: 12 days post infusion
Secondary Endpoint Platelet function
Time frame: 12 days post infusion
Secondary Endpoint Metabolomic markers
Time frame: 12 days post infusion
Secondary Endpoint Antibody coating
Time frame: 6 months post infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 38757806Bailey 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.
- Background: PubMed 19319844Zempleni J, Wijeratne SS, Hassan YI. Biotin. Biofactors. 2009 Jan-Feb;35(1):36-46. doi: 10.1002/biof.8.
- Background: PubMed 24969019Mock 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.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biotin labeled platelets in people with Healthy Volunteers, run by Bloodworks at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint Recovery and Survival (time frame: 12 days post infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07513532, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.