Red Blood Cell (RBC) Survival Following Transfusion in Infants

Completed · Phase 2

Conditions studied: Neonatal Anemia

In brief

OUR OVERALL HYPOTHESIS is that post-transfusion survival of allogeneic and autologous RBCs can be accurately quantified in anemic human infants using biotin-labeled RBCs combined with mathematical modeling that adjusts for confounding factors commonly encountered in neonates. These confounding factors include 1) dilution of labeled RBC as a result of growth stimulated erythropoiesis, anemia stimulated erythropoiesis, and blood transfusion; 2) loss of labeled RBC due to laboratory phlebotomy; and 3) variable RBC life spans resulting from RBCs having been produced at different developmental periods and under varying rates of erythropoiesis. In contrast to infants, adjustment for these factors is not necessary in healthy adults under conditions of steady state erythropoiesis. Instead in adults, RBC survival is typified by a linear decline in concentration of labeled RBCs over time. When this line is extrapolated to zero concentration, the intercept with the time axis represents the mean potential lifespan (MPL) of RBCs. (\<7 d) and stored (\>21 d) allogeneic adult RBCs transfused in the same infant.

Key facts

Study ID

NCT00731588

Run by

John A Widness

People needed

140

Starts

2008-06-01

Expected to finish

2018-03-02

Last updated by the study team

2021-08-13

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or post-menopausal females
• 18-65 years of age.
• Weight >110 lbs.
• Healthy- the subject feels well and can perform normal activities.
• Hemoglobin at or above 12.5 g/dL or hematocrit at or above 38%.
• Note: Members of the research team that are not supervised or under the employee of the PI may participate in the study.

You may not qualify if…

• Presence of chronic illness unless the subject is being treated and the condition is under control.
• Consumption of biotin supplements or raw eggs.
• Premenopausal women.
• Blood donation in the previous 8 weeks (single donation) or 16 weeks (double red cell donation).
• Blood loss in the previous 8 weeks due to epistaxis, gastrointestinal blood loss, trauma, significant diagnostic phlebotomy loss (i.e., > 30 mL total), or other significant bleeding
• Treatment with antibiotics within the last 7 days. Antibiotics for prevention of an infection or treatment of acne are not exclusion criteria.
• Note: If study subjects experience any of these conditions associated with blood loss or donate any blood products, they will not be included in the primary analysis but will be replaced.
• Infant Study:
• MOTHERS FOR PLACENTAL BLOOD COLLECTION AND MOTHERS OF INFANT STUDY SUBJECTS
• Inclusion Criteria:
• >/= 24 weeks gestation
• mothers who deliver through the birth canal or by c-section can be included in the study.
• Exclusion Criteria:
• Pregnant with fetus with major congenital anomaly.
• Clinically suspected or documented maternal chorioamnionitis (This only applies to infant study subjects receiving autologous RBCs from the placenta).
• Viral or bacterial infection (e.g. HIV, Hepatitis B, Hepatitis C, Primary Herpes, Tuberculosis) based on clinically available prenatal or postnatal test results in the mother's medical record. (This only applies to infant study subjects receiving autologous RBCs from the placenta.)
• minor mothers (<18 years old) are excluded from the study.
• INFANT STUDY SUBJECTS
• Inclusion Criteria:
• Newborns >/=24 weeks gestation who are patients in the Neonatal Intensive Care Unit (NICU) at UIHC that:
• Are being treated with the expectation of survival.
• Exclusion Criteria:
• Difference of more than 5% in the percentage of HbF cells (measured by flow cytometry in the Widness lab) between blood harvested from the placenta and that from discarded neonatal blood in the first day of life and before the first neonatal blood transfusion. This is done to exclude the rare possibility of transfusing newborns with blood that is contaminated with a significant proportion of their mother's blood if a maternal-to-placenta bleed occurs after umbilical cord clamping is done. (This only applies to infant study subjects receiving autologous RBCs from the placenta.)
• Need of emergent blood transfusion as determined by the subject's medical care team.
• Hematological diseases (except for anemia associated with phlebotomy loss and prematurity)

Where it is running

• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Iowa — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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