Status:
COMPLETED
Red Blood Cell (RBC) Survival Following Transfusion in Infants
Lead Sponsor:
John A Widness
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Neonatal Anemia
Eligibility:
All Genders
1-6 years
Phase:
PHASE2
Brief Summary
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 mod...
Detailed Description
Phase I: Includes only Aim #1 from Thrasher Foundation Grant in which adult subjects will be studied. SPECIFIC AIM #1 (Thrasher Foundation Grant): To develop in vitro and validate in vivo in adult hu...
Eligibility Criteria
Inclusion
- Adult Study:
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2018
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00731588
Start Date
June 1 2008
End Date
March 2 2018
Last Update
August 13 2021
Active Locations (2)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
2
University of Iowa
Iowa City, Iowa, United States, 52242