RECESS suggests RBC age doesn’t affect outcomes

November 4, 2014|Hematology and Oncology

Outcomes

The study’s primary outcome was the change in multi-organ dysfunction score (ΔMODS) at 7 days. The MODS system includes assessments of respiratory, renal, hepatic, cardiovascular, hematologic, and neurologic function.

“The MODS system was chosen as the primary endpoint because the data elements are objective and readily available,” Dr Stein said. “MODS also incorporates organ dysfunction and not just frank organ failure. It correlates with mortality, with length of stay, and does incorporate death. MODS has been validated in other studies and has been used in other transfusion trials, including TRICC.”

To calculate 7-day ΔMODS, the researchers identified the worst score for each organ system through day 7 after surgery, discharge, or death. The 7-day MODS was the sum of the worst score for each organ system, and the 7-day ΔMODS was the pre-surgery MODS subtracted from the 7-day MODS.

Secondary outcomes were the 28-day ΔMODS, 28-day mortality, and the incidence of serious adverse events.

There was no significant difference between the arms with regard to 7-day or 28-day ΔMODS.

For the 7-day ΔMODS, the mean was 8.5±3.6 in the newer RBC arm and 8.7±3.6 in the older RBC arm. The unadjusted difference and the difference adjusted for baseline MODS were both -0.02.

For the 28-day ΔMODS, the mean was 8.7±4.0 in the newer RBC arm and 9.1±4.2 in the older RBC arm. The unadjusted difference and the difference adjusted for baseline MODS were both -0.3.

There was no significant difference between the arms in time to death (P=0.50), 7-day mortality (P=0.43), or 28-day mortality (P=0.57). The rate of 7-day mortality was 2.8% in the newer RBC arm and 2.0% in the older RBC arm. The 28-day mortality was 4.4% and 5.3%, respectively.

There was no significant difference in the percentage of subjects with 1 or more serious adverse events. The rate was 53% in the newer RBC arm and 51% in the older RBC arm (P=0.72).

Taking these results together, Dr Stein concluded that differences in the storage duration of RBCs did not translate to significant differences in “key clinical outcomes.”