Cold Apheresis Platelets in PAS

Status unconfirmed · Phase 1

Conditions studied: Platelet Transfusion

In brief

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.

Key facts

Study ID

NCT02754414

Run by

Bloodworks

People needed

80

Starts

2016-04-01

Expected to finish

2019-01-01

Last updated by the study team

2018-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Bloodworks Northwest (formerly Puget Sound Blood Center) — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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