Recovery and survival of stem cell originated red cells
- Conditions
- Blood transfusionNot Applicable
- Registration Number
- ISRCTN42886452
- Lead Sponsor
- HS Blood and Transplant R&D Office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 15
Participant Inclusion Criteria (blood donors)
Blood donors must satisfy all the following criteria to be eligible for the study:
1. Born after 1st January 1996
2. Able to donate whole blood
3. Fulfil all requirements to donate whole blood for transfusion according to UK Blood Services definition at the time of donation
4. Previous successful whole blood donation
5. Willing to consent to their blood donations being used for the trial, including scheduling donation appointments to suit the needs of the trial
Participant Inclusion Criteria (recipients)
The participants (recipients) must satisfy all the following criteria to be eligible for the study:
1. Over 18 years of age
2. In good general health
3. Female and of no child-bearing potential (sterilised, post-hysterectomy or post-menopausal) or male
4. Has a blood group profile that is compatible with one of the donors who will donate units of blood for the study
5. Willing to accept that participation in the trial will prevent them from becoming a blood donor or donating blood in the future, as is the case for individuals who have received a blood transfusion. Willing to accept that participation in the trial may affect their ability to donate organs or tissues in the future.
6. Able and willing to keep to the trial schedule
7. Able and willing to provide informed consent to participate
8. Female participants will need to have a negative pregnancy test on the day of infusion, even though they will have confirmed they have no child-bearing potential. Based on the dose of radiation received, there is no requirement for male participants to use contraception or for any recipients to avoid proximity with pregnant women
Current exclusion criteria as of 13/02/2024:
Participant Exclusion Criteria (blood donors)
Blood donors may not donate for the study if ANY of the following apply:
1. Confirmed positive for any microbiological tests performed on blood donors on a sample tested at the time of donation (Hepatitis B (HBV), Hepatitis C (HCV), Hepatitis E (HEV), Human Immunodeficiency Virus (HIV), Human T-cell Lymphotropic Virus (HTLV), syphilis)
2. A positive direct antiglobulin test (DAT)
3. The presence of Sickle Cell Trait (HbAS), glucose-6-phosphate dehydrogenase (G6PD) deficiency, pseudohyperkalaemia
4. Have plans to travel in regions that would justify their deferral as a blood donor at the time of donation
5. Within 30 days of participating in another clinical trial, at the CI’s discretion
6. Unable to use videoconferencing for study visits, at the CI's discretion
Participant Exclusion Criteria (recipients)
Potential participants (recipients) may not enter the study if ANY of the following apply:
screening tests.
2. Previous splenectomy.
3. Participation in another clinical trial within the last 30 days or currently participating in another clinical trial.
4. Receipt of radio-isotopes within the last 12 months, unless given as part of the RESTORE trial.
5. Past or present occupational exposure to radiation that necessitates or necessitated the wearing of a monitoring badge
6. Known allergy to Cr-51
7. Known allergies warranting the use of adrenaline (EpiPen)
8. Positive for clinically significant red cell alloantibodies, as detected by routine serological methods, including 3 cell screen.
9. Positive for any other cross-match reactivity on screening.
10. Positive pregnancy test
11. Females that are breastfeeding
12. Surgery planned for the period of study participation unless the CI/screening physician deems the risk of the participant experiencing substantial blood loss during that surgery as very low and unlikely to require a blood transfusion.
13. Subject to enhanced COVID-19 restrictions at the time of recruitment, due to clinical status, at the physician’s discretion (e.g. shielding” or clinically vulnerable”).
14. Unable to use videoconferencing for study visits, at the CI/trial physician’s discretion.
Previous exclusion criteria:
Participant Exclusion Criteria (blood donors)
Blood donors may not donate for the study if ANY of the following apply:
1. Confirmed positive for any microbiological tests performed on blood donors on a sample tested at the time of donation (Hepatitis B (HBV), Hepatitis C (HCV), Hepatitis E (HEV), Human Immunodeficiency Virus (HIV), Human T-cell Lymphotropic Virus (HTLV), syphilis)
2. A positive direct antiglobulin test (DAT)
3. The presence of Sickle Cell Trait (HbAS), glucose-6-phosphate dehydrogenase (G6PD) deficiency, pseudohyperkalaemia
4. Have plans to travel in regions that would justify their deferral as a blood donor at the time of donation
5. Within 30 days of participating in another clinical trial, at the CI’s discretion
Participant Exclusion Criteria (recipients)
Potential participants (recipients) may not enter the study if ANY of the following apply:
1. Any clinically relevant abnormality on history, physical examination or laboratory screening tests
2. Previous splenectomy
3. Participation in another clinical trial within the last 30 days or currently participating in another clinical trial
4. Receipt of radio-isotopes within the last 12 months
5. Past or present occupational exposure to radiation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Co-primary outcome measures:<br>1. Safety as assessed by:<br>1.1. Serological detection of new red cell alloantibodies against standard and/or manufactured red blood cells at 120 days after the first infusion of red blood cells and at up to 180 days after the second infusion of red blood cells. <br>1.2. Description of all serious adverse reactions that occur from day of infusion of RBCs until up to 180 days after the second infusion of red blood cells.<br>2. Survival of Red Blood Cells is measured as the time it takes for 50% of the radiolabelled RBCs to be cleared from the circulation (T50). Blood samples are taken at 5, 7.5, 10, 12.5, 15, 30 and 60 minutes post transfusion of the radiolabelled RBCs and then at 24 hours and then on days 2, 3, 7, 14, 21, 28, 35, 42, 49 75, 100 and 120.
- Secondary Outcome Measures
Name Time Method Post-transfusion recovery of Red Blood Cells at 24 hours (PTR24) is measured by calculating the proportion of red blood cells infused that remain in the circulation at 24 hours following infusion