Assessment of Whole Blood Cold Stored Platelets

Completed · Not applicable

Conditions studied: Healthy

In brief

The purpose of this study is to determine the life span and functional characteristics of platelets derived from whole blood that has been stored in a refrigerator for up to 21 days. Currently, platelets are separated from red cells shortly after donation and stored at room temperature for no longer than 5 days. This study is considered experimental because; 1) we will be keeping platelets in the original whole blood donor unit in the refrigerator, and 2) we will be reinfusing a small portion of that donation back into the study-subject-donor and tracking how many of the transfused platelets from that unit circulate in the study-subject-donor in the hours and days after transfusion.

Key facts

Study ID: NCT02006368
Run by: Bloodworks
People needed: 31
Starts: 2013-10-01
Expected to finish: 2015-03-01
Last updated by the study team: 2017-08-04

Who can join

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

You may qualify if…

The subject is in good health, is taking no excluded medications, and satisfies the Blood Center's criteria to donate blood products. Criteria will also include the following guidelines:
Meets whole blood/platelet donor suitability requirements as defined in 21 CFR 640.3 and set forth by the AABB (Reference Standard 5.4.1A, 2006). Past travel restrictions do not apply for this study.
Weight ≥50 kg (110 pounds)
Hemoglobin/hematocrit: ≥12.5 g/dL/38%
Temperature: less than or equal to 37.5 degrees C
Resting blood pressure: systolic less than or equal 180 mmHg; diastolic ≥100 mmHg
Resting heart rate: 50 to 100 beats per minute
Age ≥ 18 years, of either sex;
Able to read, understand and sign the informed consent document and commit to the study follow-up schedule;
Subjects must have good veins for whole blood collection and follow-up blood draws;
Subjects of child-bearing potential must agree to use an effective contraceptive during the course of the study;
Those subjects who will be reinfused within 10 days of their 500 mL WB collection must meet the criteria for donating a double RBC unit to accommodate the sampling volume that will occur shortly thereafter:
Male subjects must weigh a minimum of 130 lbs and be at least 5'1" tall
Female subjects must weigh a minimum of 150 lbs and be at least 5'5" tall
Both male and female subjects must have a Hematocrit of ≥ 40%;

You may not qualify if…

Any serious medical illness and/or therapy, including: abnormal bleeding episodes, clotting or bleeding disorder, evidence of anemia, myocardial infarction, uncontrolled hypertension, heart disease, surgery with bleeding complications, epilepsy or any major surgery (with general or spinal anesthesia) within the last 6 months;
Taking aspirin, Alka-Seltzer™, clopidogrel, or other "anti-platelet" drugs within 7 days prior to donation.
Taking any nonsteroidal anti-inflammatory drug (for example: Motrin™, Advil™, or ibuprofen) within 3 days prior to donation.
Taking any anticoagulant medications (for example Coumadin, dabigatran, rivaroxaban or any medications chemically related to heparin).
Currently pregnant or nursing within the 6 weeks prior to enrollment as assessed during interview. Current status is confirmed by pregnancy test prior to radioisotope infusion.
Inability to comply with the protocol in the opinion of the investigator.
Participation in another investigational trial that would potentially interfere with the analysis of this investigation (e.g., pharmaceutical);
Have participated in ≥ 4 research studies involving radioisotopes within the last 12 months.

Where it is running

Puget Sound Blood Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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