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.

NCT07513532 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BR-PROSPECT 1.0
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Secondary Endpoint Platelet function

  12 days post infusion

• Secondary Endpoint Platelet function

  12 days post infusion

• Secondary Endpoint Platelet function

  12 days post infusion

• Secondary Endpoint Platelet function

  12 days post infusion

• Secondary Endpoint Platelet function

  12 days post infusion

Study Arms (1)

Biotin labeled platelets

EXPERIMENTAL

Donor platelets labeled with biotin,

Biological: Biotin labeled platelets

Interventions

Biotin labeled platelets BIOLOGICAL

Biotin labeled platelets stored at room temperature for 3 days.

Biotin labeled platelets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bloodworks: lead

Study Sites (1)

Bloodworks Northwest Research Institute

Seattle, Washington, 98102, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 38757806 BACKGROUND

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

  PMID: 19319844 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.

  PMID: 24969019 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Up to 18 participants to achieve a total of 12 participants with evaluable stored biotinylated and radiolabeled and fresh radiolabeled recovery and survival data.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: April 7, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)