Cold Apheresis Platelets in PAS (CAPP)
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98102
- Recruiting
- Bloodworks Northwest (formerly Puget Sound Blood Center)
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Contact:
- Lynda B Fitzpatrick, RN
- Phone Number: 206-689-6285
- Email: lyndaf@BloodWorksNW.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Healthy Volunteers
Autologous, cold stored, PAS/plasma suspended platelets stored for various periods (3 to 20 days).
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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.
The apheresis platelet unit will be stored, without agitation, at 4°C, for up to 20 days.
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.
Tests to evaluate platelet function will be performed on the platelet unit on day of collection and end of storage
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal storage time with acceptable recovery and survival (as defined below)
Time Frame: up to 20 days storage at 4°C
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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.
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up to 20 days storage at 4°C
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016 - 01
- CAPI (Other Identifier: BloodworksNW)
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