Red Blood Cell (RBC) Survival Following Transfusion in Infants - Full Text View

Purpose

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.

Condition	Intervention	Phase
Neonatal Anemia	Biological: Transfused Biotin RBCs	Phase I

MedlinePlus related topics:

Anemia Blood Transfusion and Donation

Drug Information available for:

Biotin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study

Official Title:	Red Blood Cell Survival Following Transfusion in Infants

Further study details as provided by University of Iowa:

Primary Outcome Measures:

To develop in vitro and validate in vivo in adults the capability for biotinylating RBCs at up to 5 discrete densities that are measurable by flow cytometry. [ Time Frame: 5 min - 6 mo post transfusion of biotin RBC's ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess if antibodies to biotin-labeled RBCs may develop and to assess if the biotinylated RBCs may be removed ot destroyed by the subject's circulatory system. [ Time Frame: 5 min - 6 mo post transfusion of biotin RBCs ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

PPG1A: Experimental

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

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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731588

Contacts


Contact: Gretchen Cress	319-356-2151	gretchen-cress@uiowa.edu

Locations


United States, Iowa
	University of Iowa	Recruiting
	Iowa City, Iowa, United States, 52242
	University of Iowa Hospitals and Clinics	Recruiting
	Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

University of Iowa

National Institutes of Health (NIH)

Thrasher Research Fund

Investigators


Principal Investigator:	John A Widness, MD	University of Iowa

More Information

Responsible Party:	University of Iowa ( Dr. John A. Widness, Professor )
Study ID Numbers:	200710747, 2P01HL046925-11
First Received:	August 5, 2008
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00731588
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hematologic Diseases

Anemia

Infant, Newborn, Diseases

Biotin

Anemia, Neonatal

ClinicalTrials.gov processed this record on October 31, 2008

Sponsors and Collaborators:	University of Iowa National Institutes of Health (NIH) Thrasher Research Fund
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00731588