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.

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: Biotin labeled platelets

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 Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98102
      • Recruiting
      • Bloodworks Northwest Research Institute
      • Contact: Patricia L Klotz, BSN; Phone Number: 206-568-2238; Email: pklotz@bloodworksnw.org
      • Principal Investigator: Moritz Stolla, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biotin labeled platelets; Donor platelets labeled with biotin,	Biological: Biotin labeled platelets; Biotin labeled platelets stored at room temperature for 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bloodworks

Publications and helpful links

General 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.
• Zempleni J, Wijeratne SS, Hassan YI. Biotin. Biofactors. 2009 Jan-Feb;35(1):36-46. doi: 10.1002/biof.8.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BR-PROSPECT 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No