FREQUENCY OF IMMEDIATE ADVERSE-EFFECTS ASSOCIATED WITH APHERESIS DONATION

BACKGROUND: Apheresis donation is considered safe, but the incidence o f adverse effects has not been determined in a large multicenter serie s of donations with modern instruments. STUDY DESIGN AND METHODS:The H emapheresis Committee of the American Association of Blood Banks devis ed a uniform questionnaire that asked about 32 specific adverse effect s. Transient paresthesia and mild vasovagal events were excluded. A su rvey was conducted in 1995; 17 centers returned 19,611 responses conce rning 250 to 2,000 consecutive apheresis donations per center. RESULTS : Six hundred adverse effects were reported in 428 donations (2.18% of donations). Pain or hematoma at a venipuncture site was the most comm on response (1.15% of donations); only 203 donations had other (nonven ipuncture) adverse effects (1.04%). Total and nonvenipuncture rates we re, respectively, 4.84 and 2.92 percent for 2,295 first donations and 1.78 and 0.77 percent for 17,303 repeat donations (p<0.001). Rates of nonvenipuncture symptoms in first and repeat donations were, respectiv ely, citrate-induced nausea and/or vomiting, 0.87 and 0.27 percent; te tany, 0.09 and 0.04 percent; palter and/or diaphoresis, 1.87 and 0.32 percent; vasovagal nausea and/or vomiting, 0.87 and 0.13 percent; sync ope and/or seizure, 0.39 and 0.04 percent; and chills and/or rigors, 0 .31 and 0.01 percent. The overall rate of donor unconsciousness was 0. 08 percent. Hemolysis was reported twice. Clotting or leakage occurred in 0.08 percent of donations, and inability to return blood occurred in 0.16 percent. No life-threatening adverse effects were reported. Pr ocedure-specific nonvenipuncture rates were 1.05 percent of 17,584 pla telet donations, 0.67 percent of 594 white cell donations, and 0.37 pe rcent of 1,354 plasma donations. Center-specific rates varied from 0.3 2 to 6.81 percent of donations for total adverse effects and from 0.11 to 2.92 percent of donations for nonvenipuncture events. CONCLUSION: Apheresis donation is a safe undertaking, suitable for voluntary blood donors, with a very low risk of serious adverse effects. The risk of unconsciousness is lower than that found in many studies of whole-bloo d donation.