A RANDOMIZED, DOUBLE-BLIND COMPARISON OF DONOR TOLERANCE OF 400 ML, 200 ML, AND SHAM RED-CELL DONATION

Background: Volume replacement could allow the safe collection of twic e the normal amount of red cells In a standard donation. Studies in sm all numbers of donors have shown that a temporary decrease in red cell mass is well tolerated when donors give twice the usual amount (170-2 25 mL) of red cells in a standard 405- to 495-mL donation. Sham-donati on control groups have not been included in previews studies of increa sed red cell donation, and perceptions of donation effects could have been biased. Study Design and Methods: In the study reported here, 17 male and 13 female volunteers were randomly assigned to make a sham do nation, 1-unit donation, or 2-unit donation on an automated blood cell separator. Donor tolerance was assessed by ambulatory heart rate moni toring and by a poststudy interview. Hemoglobin, hematocrit, ferritin, serum iron, total iron-binding capacity, red cell 2,3 DPG, and serum erythropoietin were measured before and after donation for comparison of the erythropoietic responses in the three study groups. Results: Re d cells collected totaled 206 +/- 10 mL in the 1-unit group and 414 +/ - 21 mL in the 2-unit group. Changes in heart rate, systolic blood pre ssure, and diastolic blood pressure with donation and changes in heart rate recorded by ambulatory monitoring did not differ for the experim ental groups. Postdonation changes from baseline values were evaluated on Days 2, 7, and 14. Changes in hemoglobin were significantly differ ent between groups (p<0.017) in all postdonation tests. There were dif ferences between groups in erythropoietin response, red cell 2,3 DPG, ferritin levels, and hemoglobin synthesis. Hemoglobin synthesis and me an changes in 2,3 DPG, erythropoietin, ferritin, and postdonation hemo globin were greater in the 2-unit group than in the 1-unit group. Conc lusion: Donor tolerance of red cell donations of 414 +/- 21 mL, a volu me of red cells twice that in a standard 450-mL blood donation, does n ot differ from donor tolerance of standard or sham donations. Physiolo gic adjustments and the hematopoietic response to reduced red cell mas s were greater in the 2-unit group, but the donation of 1 unit or 2 un its did not cause detectable symptoms of reduced oxygen-carrying capac ity.