To evaluate whether the RBCs derived from WB and processed with the Reveos system using the non-DEHP disposable sets meet the US criteria for 24-hour recovery after 42 days of storage.
ID
Source
Brief title
Condition
- Red blood cell disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate whether the RBCs derived from WB and processed with the Reveos
system using the non-DEHP disposable sets meet the US criteria for 24-hour
recovery after 42 days of storage.
Secondary outcome
Secondary objective: To ensure RBCs derived from WB and processed with the
Reveos system using the non-DEHP disposable set meet the European Directorate
for the Quality of Medicines; Health Care (EDQM) criteria for a transfusable
RBC product.
Background summary
Poly-vinyl-chloride (PVC), a type of plastic, is commonly used in the medical
industry to produce flexible products such as blood bags. To make PVC flexible,
plasticizers are added, with di(2-ethylhexyl)phthalate (DEHP) being the most
widely used plasticizer worldwide. DEHP has been used in medical devices,
including blood bags, since 1955 due to its ability to preserve the quality of
red blood cells during storage. Years ago, concerns about the toxic effects of
DEHP on fertility were raised due to animal studies. Consequently, the European
Union (EU) implemented bans on DEHP use in toys and cosmetics, and restrictions
on its use in the food industry. More recently, the EU decided to ban DEHP
plasticizers in medical equipment, including blood bags, with expected sun
setting in 2030. Consequently, blood bag system manufacturers are now exploring
alternative plasticizers. Laboratory (pre-clinical) research using the Reveos
Blood Bag Set shows comparable results to current "plastic" DEHP blood bags in
terms of red blood cell quality. However, it is important to show that the red
blood cells also function after being transfused into individuals. Beside the
EU, the blood bags may also be used in the United States (US) after approval.
Therefore, the maximum accepted shelf life will be tested according to the US
directive (42 days of storage).
Study objective
To evaluate whether the RBCs derived from WB and processed with the Reveos
system using the non-DEHP disposable sets meet the US criteria for 24-hour
recovery after 42 days of storage.
Study design
This is a prospective, open-label study to evaluate WB derived RBCs processed
using the Reveos system with an investigational non-DEPH disposable set
(LR-EXT). This study will be conducted in one phase, addresses the main
objective, which is to assess the autologous in vivo recovery of biotin labeled
LR-RBCs derived from WB processed using the Reveos system and stored in PAGGSM
for 42 days.
Intervention
Phase I: biotinylated RBCs stored for 35 days.
Phase II: biotinylated RBCs stored for 42 days.
Study burden and risks
Recently, it was shown that the use of biotin labelled RBCs for transfusion
(METC protocol 2012-299) is safe in healthy volunteers. Transfusions will be
prepared and transfused using the standard clinical protocols by Sanquin blood
bank and the Amsterdam UMC, location AMC.
West Collins Avenue 10811
Lakewood CO 80215
US
West Collins Avenue 10811
Lakewood CO 80215
US
Listed location countries
Age
Inclusion criteria
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
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84333.000.23 |