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
|Condition or disease||Intervention/treatment||Phase|
|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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|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|
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.
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.
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.
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).
- 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 ]
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|