Cold Apheresis Platelets in PAS

NCT02754414 | Unknown Phase 1

• 2 other identifiers: 2016 - 01CAPI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

platelets; transfusion; cold storage; apheresis

Outcome Measures

Primary Outcomes (1)

• Maximal storage time with acceptable recovery and survival (as defined below)

  Tables of recovery and survival summary statistics will display values by group from fresh and stored platelets. Recovery and survival of stored platelets as percentage of corresponding fresh platelets will be plotted against days stored. Regression methods will be used to determine if there is evidence of any trend in the mean storage or recovery of 4°C stored platelets with respect to storage time as a percentage of each subject's fresh platelet results. Histograms of recovery and survival as percentage of 4°C stored platelet measurements will be plotted, and corresponding confidence intervals will be calculated.

  up to 20 days storage at 4°C

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

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

Procedure: Apheresis platelet collection; Other: Refrigerated storage of apheresis platelets in PAS/plasma; Radiation: Infusion of aliquot of autologous radiolabeled platelets; Other: In vitro tests

Interventions

Apheresis platelet collection PROCEDURE

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.

Healthy Volunteers

Refrigerated storage of apheresis platelets in PAS/plasma OTHER

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

Healthy Volunteers

Infusion of aliquot of autologous radiolabeled platelets RADIATION

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.

Healthy Volunteers

In vitro tests OTHER

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

Healthy Volunteers

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bloodworks: lead

Study Sites (1)

Bloodworks Northwest (formerly Puget Sound Blood Center)

Seattle, Washington, 98102, United States

RECRUITING

MeSH Terms

Interventions

In Vitro Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Lynda Fitzpatrick, RN

CONTACT

206-689-6285; lyndaf@BloodWorksNW.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Platelet Transfusion Research

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 28, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

US (1)