An In Vivo 24-Hour Recovery Study of Leukoreduced RBCs After Automated Separation of Whole Blood by the Reveos System and Storage With Non-DEHP Disposables.
- Conditions
- Anemie10038158
- Registration Number
- NL-OMON56734
- Lead Sponsor
- Terumo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 26
Inclusion criteria for participant selection:
1. Healthy volunteers
2. Age >= 18 years < 60 years
3. Normal health status as per Sanquin National Blood Bank criteria for healthy
donors
4. Able to commit to the study schedule
5. Participants of childbearing potential must agree to use a medically
acceptable method of contraception throughout of the study
6. Participants of childbearing potential must be willing to take a pregnancy
test prior to WB donation
7. Signed and dated informed consent form within 30 days of the Day 0 visit
Exclusion criteria for participant selection:
1. Pregnant or nursing females
2. Serum ferritin <12 ng/mL
3. Has previously completed this study with evaluable data points
4. Participation currently, or within the past 30 days, in another
investigational trial that would potentially interfere with the analysis of
this investigation (e.g. pharmaceutical)
5. Participants who are deferred from volunteer community donations as per
Sanquin National Blood Bank criteria for healthy donors
6. As determined by the Investigator a. Has been diagnosed with a blood
disorder(s) affecting RBC characteristics (e.g. G6PD deficiency). b. Reported
history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies
c. Clinically significant acute or chronic disease d. Reported history or known
hypersensitivity to biotin and iodine e. Treatment with any medication as
specified in site deferral list f. Current drug use g. Currently abusing
alcohol. Alcohol abuse is defined for men, consuming more than 4 drinks on any
day or more than 14 drinks per week and for women, consuming more than 3 drinks
on any day or more than 7 drinks per week
7. Previously transfused with RBCs within the last 120 days
8. A positive biotin antibody test if they have received any biotin labeled
blood products in the past
9. Blood loss of more than 500 mL < 3 months, including blood donation
10. Other unspecified reasons that, in the opinion of the investigator make the
subject unsuitable for enrollment
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate whether the RBCs derived from WB and processed with the Reveos<br /><br>system using the non-DEHP disposable sets meet the US criteria for 24-hour<br /><br>recovery after 42 days of storage. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objective: To ensure RBCs derived from WB and processed with the<br /><br>Reveos system using the non-DEHP disposable set meet the European Directorate<br /><br>for the Quality of Medicines; Health Care (EDQM) criteria for a transfusable<br /><br>RBC product.</p><br>