Improving White Blood Cell Collection From Healthy Donors (NCT01553214) | Clinical Trial Compass
RecruitingPhase 4
Improving White Blood Cell Collection From Healthy Donors
United States1,000 participantsStarted 2012-12-31
Plain-language summary
Background:
\- White blood cells called granulocytes help the body fight infection. People who have had chemotherapy or bone marrow transplants may have very low numbers of these cells. Transfusions of these cells can help improve the body's ability to fight infection. However, most of the cells are located in the bone marrow or spleen, and are hard to collect from healthy donors. Two drugs, filgrastim and dexamethasone, can help move the cells to the bloodstream to be collected by apheresis. Researchers want to study the best ways to collect these white blood cells. They also want to monitor the effects of the injections and donations on the volunteer donors.
Objectives:
\- To improve the amount and quality of granulocytes (white blood cells) collected by apheresis for donation.
Eligibility:
\- Healthy volunteers between 18 and 75 years of age.
Design:
* Participants will be screened with a physical exam and medical history. Initial blood tests will be done to check for eligibility.
* Participants will donate granulocytes by apheresis a maximum of 12 times in 1 year. Donations will not usually be requested more often than every 4 weeks. Donors will be allowed to decline participation at any time.
* Participants will have one injection of filgrastim 12 to 24 hours before donation. They will also have two tablets of dexamethasone 12 hours before donation.
* White blood cells will be collected through apheresis. The apheresis will last about 2 hours.
* Participants will be eligible to donate until they reach their 76th birthday.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Donors shall meet all donor eligibility criteria for allogeneic blood donors, as defined in the most recent editions of the AABB Standards and FDA Code of Federal Regulations (21CFR640). In addition, donors shall meet the following restrictions:
* Age greater than or equal to18 and less than or equal to 75 years
* If hypertension is present, must be well-controlled on medications
* If peptic ulcer disease has been diagnosed in the past, symptoms must be well-controlled on medications
* If cataracts have been diagnosed in the past, records from subject s ophthalmologist must be obtained indicating type of cataract. If PSC was diagnosed in the past, subject may receive G-CSF but not dexamethasone. The only exception to this is a history of bilateral cataract extractions due to PSC.
EXCLUSION CRITERIA:
* Information obtained from health history screen that does not meet the allogeneic donor eligibility criteria of the AABB Standards or the FDA CFR.
* Weight less than 50 kg (110 lbs).
* History of coronary heart disease
* Uncontrolled hypertension (systolic BP \>160, diastolic BP \>100)
* Diabetes mellitus requiring insulin
* Active, symptomatic peptic ulcer disease
* History of iritis or episcleritis
* Sickle cell disease (sickle trait is acceptable). Testing for hemoglobin S is not required.
* Lithium therapy
* Pregnancy or nursing (breast feeding)
* Renal function eGFR \< 45 ml/min/1.73m(2)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Operational feasibility and impact of managing a volunteer community donor granulocytapheresis program
Timeframe: Annually
Trial details
NCT IDNCT01553214
SponsorNational Institutes of Health Clinical Center (CC)