Red cell storage studies on deck or underway
RECESS or Red Cells Storage Duration study. This U.S.-based study is a large, multicenter, randomized trial of red blood cell storage time and postoperative outcomes. “It will randomize 1,800 cardiac surgery patients, including some pediatric patients, at 15 blood centers, who will be receiving either red blood cells of 10 days’ age or 21 days’ age or longer,” says Dr. Dan Waxman of Indiana Blood Center. “The primary outcome will be change in composite MODS or multiorgan dysfunction score.” An ancillary study called MARS (Mechanism and Repository Study), funded jointly with the Department of Defense, will examine the mechanism by which stored blood may cause vascular problems.
INFORM Pilot study. This study is a single-center pilot performed at an acute care hospital in Hamilton, Ontario. This feasibility randomized controlled trial aimed to randomize more than 80 percent of the transfused patients in a 1:2 ratio to receive the freshest ABO compatible blood or standard-issue (oldest) blood in the blood bank inventory. Feasibility outcomes include proportion of eligible patients randomized, contrast in age of blood between randomized treatment groups, real-time data acquisition, and impact of trial on blood outdating. In-hospital mortality was also captured; this will be the primary outcome for a larger study. The pilot is complete and will be presented at the AABB meeting this month. The investigators plan to move forward with a 25,000-patient international multicenter RCT, which should be completed in about three years.
ABLE study (Age of Blood Evaluation). In this Canadian-based international blinded controlled trial, 2,510 adult ICU patients in Canada, France, and Scotland are being randomized to receive either standard-issue red blood cells or RBCs stored seven or fewer days. Ninety-day all-cause mortality and morbidity are being compared.
ARIPI Trial (Age of Red Blood Cells in Premature Infants). This multicenter randomized Canadian trial is evaluating the effectiveness of stored versus fresh RBCs in neonates requiring transfusion.
Efficacy and Safety of Frozen RBCs for Transfusion in Trauma Patients study. A randomized trial at Oregon Health and Science University, this study is comparing outcomes of trauma patients transfused with RBCs of 0–14 days, RBCs of 15–42 days, and frozen RBCs.
ABC-PICU study (Age of Blood in Children). This randomized controlled blinded trial is being planned and will determine if RBCs less than seven days old improve outcomes compared with standard-issue RBCs. It is a 1,502-patient study in at least 30 centers in the U.S. and Canada. The study is under review for joint funding by the NHLBI and Canadian Institutes of Health Research.
An additional eight NHLBI studies will include more basic research about what happens at the cellular level when RBCs are stored. Among the topics to be examined: disruption of nitric oxide homeostasis; blood flow through capillaries; nitric oxide levels, blood flow, and oxygen absorption by patients’ tissues; the function of S-nitrosothiol in tissue oxygenation; RBC supernatant including hemoglobin, microparticles, and lipid mediators; microparticles’ role in transfusion complications; the immune effects of stored versus fresh RBCs; and hemoglobin-derived iron and the inflammatory response.
In two other studies funded by the Department of Defense, researchers will examine whether RBC storage time affects inflammatory markers, immune function, hypercoagulation, microparticles, and the incidence and magnitude of microchimerism from patients in both the ABLE and RECESS trials. A large repository will also be developed from both trials that will allow for future analysis of patient samples at five different time points out to 180 days posttransfusion.