Cold Apheresis Platelets in PAS

Last updated: May 8, 2018
Sponsor: Bloodworks
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02754414
2016 - 01
CAPI
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 andcommit to the study follow-up schedule. The ability to read and speak English isrequired for participation.

  • Subjects must have good veins for apheresis platelet collection and drawing bloodsamples.

  • Subjects of child-bearing potential (either male or female) must agree to use aneffective method of contraception during the course of the study. The followingmethods of contraception are be considered effective; abstinence, intrauterinecontraception devices, hormonal methods, barrier methods or history of sterilization.

Exclusion

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 (apheresismachine) configuration parameters.

  • Ever received radiation therapy.

  • Already participated in 4 research studies involving radioisotopes within thecontemporaneous calendar-year.

  • Taken aspirin, non-steroidal anti-inflammatory, or other platelet affecting drugswithin 72 hours of collection or infusion. Subjects who have ever been prescribedanti-platelet medications (e.g. clopidogrel) will be excluded from study participationregardless of the interval to their last dose.

  • Currently pregnant or nursing as assessed during interview. A urine pregnancy testprior 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

Total Participants: 80
Study Start date:
April 01, 2016
Estimated Completion Date:
January 31, 2019

Study Description

A single hyperconcentrated 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. The platelet unit will be stored, not-agitated, for up to 20 days at 4°C in a suspension of 35% plasma and 65% PAS (Platelet Additive Solution).

At the end of the storage period, the subject will return to receive an 111Indium Oxine (Indium 111, In-111) radiolabeled aliquot of their 4°C stored platelets. Follow-up samples from the subject will be collected approximately 2 hours post-infusion and on Days 1 (2X), 2 (2X), and 3 to calculate recovery and survival of the subject's 4°C stored platelets. The Day 1 and Day 2 the sample draws will be 2 - 10 hours apart.

In addition to radiolabeled platelet recovery and survival measurements, various in vitro assays will be performed on the day of collection at the end of 4°C storage.

One week after the infusion of the radiolabeled aliquot, the subject will return to receive a second radiolabeled aliquot of fresh platelets. To facilitate this, on the morning of the second infusion, the subject will return for collection of a 43 mL blood sample. The blood will be processed to obtain a fresh sample of the subject's platelets to serve as a control comparator. The platelets will be radiolabeled with In-111. The subject will return later in the day for infusion of the radiolabeled fresh 'control' comparator aliquot. Follow-up blood samples will be drawn at ~2 hours after the infusion on Day 0 and then on Days 1, 2, 3, 4 or 5, and 6 or 7 day post infusion to calculate recovery and survival of the subject's fresh vs. stored platelets.

Connect with a study center

  • Bloodworks Northwest (formerly Puget Sound Blood Center)

    Seattle, Washington 98102
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.