Recruiting
Phase 1

Cold Apheresis Platelets

Sponsor:

Bloodworks

Code:

NCT02754414

Conditions

Platelet Transfusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Apheresis platelet collection

Refrigerated storage of apheresis platelets in PAS/plasma

Infusion of aliquot of autologous radiolabeled platelets

In vitro tests

Study Details

Brief summary:

This is a platelet transfusion study. The purpose of this study is to measure the life span and quality of platelets stored in a refrigerator. Participants will give platelets by apheresis. Platelets will be stored for 3 -20 days. A small portion of the subject's own stored platelets will be tagged with a radioactive isotope and infused back into the participant. This will enable us to track how many transfused platelets survive after storage in the refrigerator.

Conditions

Platelet Transfusion

Study ID

NCT02754414

Start date

Apr, 2016

Status verified date

May, 2018

Completion date

Jan, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Weight: ≥ 110 pounds
  • Platelet count: ≥ 150X10\^3/mL
  • Hematocrit: 38% for females, 39% for males, but not >55%
  • Temperature: ≤ 99.5 F
  • Resting blood pressure: systolic ≤180 mmHg; diastolic ≤ 100 mmHg
  • Resting heart rate: 40 to 100 beats per minute
  • Subjects must be: at least 18 years old, of either sex
  • Subjects must be able to read, understand and sign the informed consent document and commit to the study follow-up schedule. The ability to read and speak English is required for participation.
  • Subjects must have good veins for apheresis platelet collection and drawing blood samples.
  • Subjects of child-bearing potential (either male or female) must agree to use an effective method of contraception during the course of the study. The following methods of contraception are be considered effective; abstinence, intrauterine contraception devices, hormonal methods, barrier methods or history of sterilization.

Exclusion Criteria:

Healthy subjects will be excluded from the study for any of the following reasons:

  • Unable to achieve target platelet yield of 3.0 X 1011/unit per Trima Accel (apheresis machine) configuration parameters.
  • Ever received radiation therapy.
  • Already participated in 4 research studies involving radioisotopes within the contemporaneous calendar-year.
  • Taken aspirin, non-steroidal anti-inflammatory, or other platelet affecting drugs within 72 hours of collection or infusion. Subjects who have ever been prescribed anti-platelet medications (e.g. clopidogrel) will be excluded from study participation regardless of the interval to their last dose.
  • Currently pregnant or nursing as assessed during interview. A urine pregnancy test prior to radioisotope infusion is required for women of childbearing potential.
  • Unable to comply with the protocol in the opinion of the investigator.
  • Donated granulocytes within the last 2 days.
  • Donated whole blood within the last 7 days.
  • Donated platelets or plasma within the last 28 days.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Healthy Volunteers

Autologous, cold stored, PAS/plasma suspended platelets stored for various periods (3 to 20 days).

Interventions

Apheresis platelet collection

A single apheresis platelet unit will be collected from a healthy adult volunteer subject using the Trima Accel® Automated Blood Collection System. Concurrent plasma will be collected.

Refrigerated storage of apheresis platelets in PAS/plasma

The apheresis platelet unit will be stored, without agitation, at 4°C, for up to 20 days.

Infusion of aliquot of autologous radiolabeled platelets

Fresh and stored aliquots will be labeled with Indium-111. We are administering ≤30 microcuries in both infusions for a total dose of 0.8 mSv.

In vitro tests

Tests to evaluate platelet function will be performed on the platelet unit on day of collection and end of storage

Primary outcome measure

  • Maximal storage time with acceptable recovery and survival (as defined below) [ Time Frame: up to 20 days storage at 4°C ]

Central Contacts and Locations

Central contacts

Lynda Fitzpatrick, RN

206-689-6285lyndaf@BloodWorksNW.org

Locations

Bloodworks Northwest (formerly Puget Sound Blood Center)

Recruiting

Seattle, Washington, United States, 98102

Contacts

Lynda B Fitzpatrick, RN

206-689-6285lyndaf@BloodWorksNW.org

More Information

Sponsor

Bloodworks

Last update posted

May 14, 2018

Last verified

May, 2018

Keywords

  • platelets
  • transfusion
  • cold storage
  • apheresis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bloodworks on 2018-05-14.