title: Using Hematology Data from Malaria Vaccine Research Trials in Humans and Rhesus Macaques (Macaca mulatta) To Guide Volume Limits for Blood Withdrawal.
abstract: Guidelines on safe volume limits for blood collection from research participants in both humans and laboratory animals vary widely between institutions. The main adverse event that may be encountered in large blood volume withdrawal is iron-deficiency anemia. Monitoring various parameters in a standard blood panel may help to prevent this outcome. To this end, we analyzed the Hgb and MCV values from 43 humans and 46 macaques in malaria vaccine research trials. Although the percentage of blood volume removed was greater for macaques than humans, macaques demonstrated an overall increase of MCV over time, indicating the ability to respond appropriately to frequent volume withdrawals. In contrast, humans showed a consistent declining trend in MCV. These declines in human MCV and Hgb were significant from the beginning to end of the study despite withdrawals that were smaller than recommended volume limits. Limiting the volume withdrawn to no more than 12.5% seemed to be sufficient for macaques, and at 14% or more individual animals tended to fail to respond appropriately to large-volume blood loss, as demonstrated by a decrease in MCV. The overall positive erythropoietic response seen in macaques was likely due to the controlled, iron-fortified diet they received. The lack of erythropoietic response in the human subjects may warrant iron supplementation or reconsideration of current blood volume withdrawal guidelines.
authors.affiliation: Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland;, Email: sara.hegge@usuhs.edu.
authors.forename: Sara R
authors.initials: SR
authors.lastname: Hegge
authors.affiliation: Clinical Trials Center, Naval Medical Research Center, Silver Spring, Maryland.
authors.forename: Bradley W
authors.initials: BW
authors.lastname: Hickey
authors.affiliation: Translational Biomedicine, Andover, Massachusetts.
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Mcgrath
authors.affiliation: Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland.
authors.forename: V Ann
authors.initials: VA
authors.lastname: Stewart
mesh_terms: D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000517:prevention & control; D000818:Animals; D000830:Animals, Laboratory; D035843:Biomedical Research / Q000592:standards*; D001810:Blood Volume; D001811:Blood Volume Determination; D002986:Clinical Trials as Topic; D005260:Female; D006405:Hematology / Q000592:standards*; D006801:Humans; D008253:Macaca mulatta; D017780:Malaria Vaccines; D008297:Male; D008875:Middle Aged; D018962:Phlebotomy / Q000009:adverse effects* / Q000592:standards; D012015:Reference Standards; D055815:Young Adult
chemical_list: D017780:Malaria Vaccines