ABLE-NL

Rationale

Donated red cells in the Netherlands can be stored up to 35 days. The standard procedure is to deliver the oldest available unit when a red cell transfusion is being ordered, to keep waste to a minimum. However some laboratory and clinical data suggest that giving older units could be detrimental and less effective. An international multicenter RCT is being carried out by a Canadian research group, analyzing the effect of storage time of red blood cells to answer whether fresh red cells are safer than older red cells. We wish to participate in this international study and include a Dutch subgroup within this study. Anemia is very common among the critically ill, and we have chosen to study the heterogeneous population of critically ill patients, because due to their serious illness they may benefit the most from a possible advantage of fresher red cells. We hypothesize that transfusion of “fresh” red cells (stored 7 days or less) will result in improved clinical outcomes, including 90 day mortality, through avoidance of the adverse clinical consequences of prolonged red cell storage.

Study objective

The primary objective in the international ABLE study is the 90-day all-cause mortality. Secondary objectives are (1) in hospital, ICU, 28-day and 6-month mortality, (2) the incidence of MODS, (3) the incidence of nosocomial infections, (4) the length of ICU and hospital stay. Special attention will also be paid to red cell transfusions and transfusion reactions. Within the Dutch branch of this study, the ABLE-NL, the primary objective will also be the 90-day all-cause mortality, but this endpoint will be studied in a broader patient population for the inclusion criteria in the Dutch brand of this study will be less strict. The secondary endpoints will be the same as in the international ABLE study. An additional secondary objective in the Dutch study will be the incidence of alloimmunization after red blood cell (RBC) transfusions.

Study design

The ABLE study is a double-blind, multicenter, randomized clinical trial.

Study population 

The study population of the ABLE study consist of patients >18 years of age admitted at an ICU ward who need a red cell transfusion and have an anticipated length of invasive and/or non-invasive mechanical ventilation of at least 48 hours (ABLE), or have an anticipated length of mechanical ventilation (invasive and/or non-invasive) of at least 24 hours (ABLE-NL). The high-risk subgroup that is included in the international ABLE study (and will also be included in the ABLE-NL study) consist of patients who are admitted at an ICU with an expected mortality of 25% and who need a red cell transfusion.

Intervention

One study arm will receive red cells stored 7 days or less. Their progress will be monitored and compared with the progress of the control arm who will receive red cells according to standard procedure.

Main study parameters/endpoints

A 5% risk reduction in 90-day all-cause mortality for the international ABLE study (25% -> 20%). And a 4% risk reduction in 90-day all-cause mortality in the ABLE-NL study (15% -> 11%)

Research staff 

• LMG van de Watering MD, PhD - Principal Investigator
• EK Hogervorst MD - Study manager
• BJM van der Meer MD, PhD, BMA - Leading intensivist