A prospective, double-blind, randomized clinical feasibility trial of controlling the storage age of red blood cells for transfusion in cardiac surgical patients

Abstract

Background: Recent evidence demonstrates an association between duration of storage of red blood cells (RBC) and morbidity and mortality after cardiac surgery. We studied the feasibility of two different schemes for categorizing and randomizing age of RBC units transfused in cardiac surgical patients.

Study design and methods: In Phase 1, 20 subjects were randomly assigned to standard of care (SOC) versus no RBCs with more than 21 days' storage duration. In Phase 2, 23 subjects were randomized to RBCs of 7 +/- 4 versus 21 +/- 4 days' storage duration. The age of study RBC units was masked.

Results: In Phase 1, no patients received RBCs 31 days or older in SOC, and there was overlap in storage age shared in both arms so the predefined feasibility criteria were not met. In Phase 2, it was feasible to deliver specified age RBCs to the 7-day arm (achieved in 100% of subjects), but feasibility was not demonstrated for the 21-day arm (only 50% of subjects transfused with target age RBCs). Significant differences, however, were observed between the 7 +/- 4- and 21 +/- 4-day arms with respect to age of all RBC units (6 +/- 2 vs. 18 +/- 7, p = 0.0002) and maximum age (7 +/- 2 vs. 20 +/- 7, p < 0.0001).

Conclusion: Given the current storage age distribution of available RBC inventory, use of a SOC arm in future studies is unlikely to result in a large exposure to "old" blood. It is feasible to randomize patients to "younger" RBCs (3-11 days) but design strategies are needed to provide "intermediate-aged" or "old" blood as a comparator.