Neonatal Anemia Clinical Trial
Official title:
Red Blood Cell Survival Following Transfusion in Infants
Verified date | August 2021 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | March 2, 2018 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Months |
Eligibility | Adult Study: Inclusion Criteria: - 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. Exclusion Criteria: - 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: 1. >/= 24 weeks gestation 2. mothers who deliver through the birth canal or by c-section can be included in the study. Exclusion Criteria: 1. Pregnant with fetus with major congenital anomaly. 2. Clinically suspected or documented maternal chorioamnionitis (This only applies to infant study subjects receiving autologous RBCs from the placenta). 3. 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.) 4. 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: 1) Are being treated with the expectation of survival. Exclusion Criteria: 1. 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.) 2. Need of emergent blood transfusion as determined by the subject's medical care team. 3. Hematological diseases (except for anemia associated with phlebotomy loss and prematurity) 4. Alloimmune hemolytic anemia, diffuse intravascular coagulation, and thrombosis. 5. Major congenital anomaly. 6. Sepsis with positive blood or spinal fluid culture. 7. Receiving treatment with erythropoietin (r-HuEPO) or cardiorespiratory bypass support (ECMO). 8. Overt clinical bleeding. |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa | Iowa City | Iowa |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
John A Widness | National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Thrasher Research Fund |
United States,
Mock DM, Lankford GL, Matthews NI, Burmeister LF, Kahn D, Widness JA, Strauss RG. Accelerated removal of antibody-coated red blood cells from the circulation is accurately tracked by a biotin label. Transfusion. 2012 May;52(5):1097-105. doi: 10.1111/j.153 — View Citation
Mock DM, Matthews NI, Strauss RG, Burmeister LF, Schmidt R, Widness JA. Red blood cell volume can be independently determined in vitro using sheep and human red blood cells labeled at different densities of biotin. Transfusion. 2009 Jun;49(6):1178-85. doi — View Citation
Mock DM, Matthews NI, Zhu S, Burmeister LF, Zimmerman MB, Strauss RG, Schmidt RL, Nalbant D, Cress GA, Widness JA. Red blood cell (RBC) volume can be independently determined in vivo in humans using RBCs labeled at different densities of biotin. Transfusi — View Citation
Mock DM, Matthews NI, Zhu S, Strauss RG, Schmidt RL, Nalbant D, Cress GA, Widness JA. Red blood cell (RBC) survival determined in humans using RBCs labeled at multiple biotin densities. Transfusion. 2011 May;51(5):1047-57. doi: 10.1111/j.1537-2995.2010.02 — View Citation
Mock DM, Widness JA, Strauss RG, Franco RS. Posttransfusion red blood cell (RBC) survival determined using biotin-labeled RBCs has distinct advantages over labeling with (51) Cr. Transfusion. 2012 Jul;52(7):1596-8. doi: 10.1111/j.1537-2995.2012.03588.x. — View Citation
Nalbant D, Bhandary P, Matthews NI, Schmidt RL, Bogusiewicz A, Cress GA, Zimmerman MB, Strauss RG, Mock DM, Widness JA. Comparison of multiple red cell volume methods performed concurrently in premature infants following allogeneic transfusion. Pediatr Re — View Citation
Schmidt RL, Mock DM, Franco RS, Cohen RM, North AK, Cancelas JA, Geisen C, Strauss RG, Vlaar AP, Nalbant D, Widness JA. Antibodies to biotinylated red blood cells in adults and infants: improved detection, partial characterization, and dependence on red b — View Citation
Widness JA, Kuruvilla DJ, Mock DM, Matthews NI, Nalbant D, Cress GA, Schmidt RL, Strauss RG, Zimmerman MB, Veng-Pedersen P. Autologous Infant and Allogeneic Adult Red Cells Demonstrate Similar Concurrent Post-Transfusion Survival in Very Low Birth Weight — View Citation
Widness JA, Nalbant D, Matthews NI, Strauss RG, Schmidt RL, Cress GA, Zimmerman MB, Mock DM. Tracking donor RBC survival in premature infants: agreement of multiple populations of biotin-labeled RBCs with Kidd antigen-mismatched RBCs. Pediatr Res. 2013 De — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Discrete Biotinylated RBC Densities (up to 5 Discrete Densities) That Can be Accurately Measured by Flow Cytometry, i.e., Without Overlap. | The biotin-labeled RBCs that were studied were: 2, 6, 18, 54, and 162 µg NHS-biotinylating reagent per mL of packed RBCs. Here we report the number of discrete biotin densities without overlap as determined in vitro. | from day of blood draw this can be accomplished in 4 hours | |
Primary | RBC Survival (Life Span) in Days of Multiple, Distinct BioRBC Density Populations of Transfused Autologous RBCs in Adults and Premature Infants. | Using flow cytometry was measured for each RBC biotin density in days as determined when RBC measurement was no longer detectable. | for up to 5 months | |
Primary | RBC Survival (Life Span) in Days of Multiple, Distinct BioRBC Density Populations of Transfused Allogeneic RBCs in Premature Infants. | Using flow cytometry was measured for each RBC biotin density in days as determined when RBC measurement was no longer detectable. | for up to 4 months | |
Secondary | Number of Participants With Positive Antibody Screen in Response to Biotin-labeled RBCs. | IgG gel card agglutination test that was developed in our laboratory | 4 to 5 mo post transfusion of biotin RBCs | |
Secondary | Survival of Allogeneic RBCs in Days as Measured by the Antigenic Method Using Flow Cytometry for Comparison With BioRBC in Premature Infants | 4 months |
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