Red Blood Cell (RBC) Survival Following Transfusion in Infants
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ClinicalTrials.gov Identifier: NCT00731588 |
Recruitment Status
:
Completed
First Posted
: August 11, 2008
Last Update Posted
: December 25, 2014
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Condition or disease | Intervention/treatment | Phase |
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Neonatal Anemia | Biological: Transfused Biotin RBCs - Adults Phase I Biological: Transfused Biotin RBCs - Infants Phase II Biological: Transfused Biotin RBCs - Infants Phase III | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 140 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Red Blood Cell Survival Following Transfusion in Infants |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |

Arm | Intervention/treatment |
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Experimental: PPG1A - Adults
Phase I completed: Healthy male and post-menopausal female volunteers between the ages of 18 and 65. Volunteers must not have donated blood in the previous 8 weeks.
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Biological: Transfused Biotin RBCs - Adults Phase I
A 3 mL venous blood sample is obtained. 250 mL of blood will be drawn to a blood collection bag containing the anticoagulant CPD. Separate equal volumes of RBCs are labeled with up to five different densities of biotin. The biotinylated RBCs are resuspended in autologous plasma to achieve a 60 to 70% hematocrit. An IV is inserted for the reinfusion of the biotinylated RBCs. Three mL aliquots of blood are sampled at 5, 10, 20, and 60 minutes after infusion. The subject returns ~24 hours and 3 days after the RBC infusion to obtain a 3 mL venous blood sample. Subjects return for weekly 3 mL blood sampling.
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Experimental: PPG1B - Infants
Phase II in progress: Newborns >= 24 weeks gestation who are patients in the Neonatal Intensive Care Unit at the University of Iowa Hospitals and Clinics that are being treated with the expectation of survival.
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Biological: Transfused Biotin RBCs - Infants Phase II
After the infant's clinical care team decides that a RBC transfusion is needed, a 15mL/kilogram of body weight is ordered. Transfusion will be given in 2 parts: 1) approximately 80% of the total transfusion to be transfused over 3-4 hours and 2) approximately 20% of the total transfusion will be marked with biotin to be transfused upon completion of the first part. The bedside nurse maintains constant observation of the infant as appropriate for the infant's condition, assessing for signs and symptoms of a transfusion reaction.
Biological: Transfused Biotin RBCs - Infants Phase III
Phase III (infants) to be determined upon completion of Phase II (infants).
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- Measurement of biotinylated RBCs at up to 5 discrete densities by flow cytometry. [ Time Frame: from date of transfusion to disappearance of biotinylated RBCs in blood samples, typically 4 months. ]
- RBC survival in days of multiple, distinct populations of transfused RBCs in premature infants. [ Time Frame: 20 minutes - 4 months ]
- Long-term survival of transfused adult donor and fetal/placental RBCs in days in anemic newborn infants. [ Time Frame: 20 min - 6 months ]
- Positive antibody screen in response to biotin-labeled RBCs. [ Time Frame: 5 min - 6 mo post transfusion of biotin RBCs ]
- Survival of RBCs in days as measured by the differential agglutination, antigenic method [ Time Frame: 5 min to 5 months ]

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Ages Eligible for Study: | up to 6 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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
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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 birthcanal 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:
1) 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)
- Alloimmune hemolytic anemia, diffuse intravascular coagulation, and thrombosis.
- Major congenital anomaly.
- Sepsis with positive blood or spinal fluid culture.
- Receiving treatment with erythropoietin (r-HuEPO) or cardiorespiratory bypass support (ECMO).
- Overt clinical bleeding.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731588
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Iowa City, Iowa, United States, 52242 | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | John A Widness, MD | University of Iowa |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00731588 History of Changes |
Other Study ID Numbers: |
200710747 2P01HL046925 ( U.S. NIH Grant/Contract ) |
First Posted: | August 11, 2008 Key Record Dates |
Last Update Posted: | December 25, 2014 |
Last Verified: | December 2014 |
Additional relevant MeSH terms:
Anemia, Neonatal Anemia Hematologic Diseases Infant, Newborn, Diseases Biotin |
Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |