Prestorage Leukoreduction of Red Cells in Elective Cardiac Surgery: Results of a Double Blind Randomized Controlled Trial.

Between November 1999 and August 2002, consenting adult elective cardiac surgery patients at Oregon Health & Science University, Portland Veteran’s Administration Medical Center, and St. Vincent’s Hospital who were undergoing cardiopulmonary bypass (CPB) were randomized at admission to receive either prestorage leukoreduced red cells (PSL-RBCs) or standard red cells (S-RBCs) in a prospective double-blind fashion. Only data from those transfused were analyzed. Outcome measures included death at 60 days, 60 day infection rate, and length of hospital stay (LOS). Patients at all 3 institutions were operated on by the same group of cardiovascular surgeons. Given higher baseline infection rates for coronary artery bypass grafts (CABG) randomization was stratified by CABG vs valve replacement (VR). All RBCs were issued with blinding hoods. All platelet transfusion were prestorage leukoreduced. RBC transfusion rates were 30% for CABG, 38 % for VR, and 63% for CABG + VR. Infections were determined by infection control nurses using standardized Centers for Disease Control criteria from hospital surveillance and records and follow-up phone calls. Deaths were determined from hospital records and follow-up calls, and verified by National Death Index data. The PSL-RBC arm included 304 patients and the S-RBC arm 258 patients. The two groups were well-matched demographically and by cardiovascular risk factors. Intent-to-treat analysis showed a 60 day mortality of 9.7% in the S-RBC arm and of 4.9% in the PSL-RBC arm (p=0.029). Heart failure as the sentinel cause of death accounted for most of the difference (45.5% of deaths in the S-RBC group vs 13.3% in the PSL-LR group). Death rates were procedure specific: CABG alone > CABG + VR > VR alone. There was no significant difference between the S-RBC and PSL-RBC groups with regard to overall infection rate at 60 days. Most infections were superficial wound infections in the CABG patients; however groups did not differ in more serious infections such as bacteremia (p=0.369) or pneumonia (p=0.360). There was no significant difference between the groups with respect to LOS exclusive of in-hospital deaths. Our results essentially replicate in a North American context those of a previous European trial (