Quality of Life Outcomes of the Age of Blood In Highly Transfusion Dependent Patients with Myelodysplasia: Prospective Randomized Controlled N-of-1 Studies

Anemia is the most common objective manifestation of the myelodysplastic syndromes (MDS), and excessive fatigue is experienced in over 80% of patients. Transfusion is essential for the management of anemia in these patients. Past studies have investigated the age of transfused blood and its effect on outcome in various acute clinical settings such as critically ill, post-cardiac surgery, trauma, and brain injury patients. However, few studies have investigated the age of transfused blood in chronically transfused patients such as MDS and its impact on quality of life (QoL) and hemoglobin (Hb) levels in these populations.

The aim of our study was to compare QoL outcomes between fresh (transfused within 7 days of donation) and standard issue (transfused between 8 to 42 days, mean 20.5 days locally) blood in highly transfusion dependent patients including those with MDS. The Functional Assessment Cancer Therapy Anemia subscale (FACT-An) was utilized for QoL assessment in a series of prospective “N-of-1” trials design. An “N-of-1” study was performed for each of the participants. Each participant was randomized to receive a total of four transfusions of fresh blood and four transfusions of standard issue blood. Randomization tables were created for each participant “N-of-1” study a priori. The participants, nurses and investigators were blinded to the age of blood administered. Prior to each transfusion, and again after 24 hours, participants completed the FACT-An survey. Post transfusion Hb levels were measured prior to a subsequent transfusion. For each FACT-An parameter and Hb level, mean results were derived for the four fresh blood transfusions and for the four standard blood transfusions. These were analyzed using an unpaired Student's t-test.

Twenty patients were enrolled into the study at the London Health Sciences Centre (LHSC), London, Ontario, Canada. Participants included 8 males and 12 females with a mean age of 64.5 years. There were a total of 13 MDS participants (5 males, 8 females) and seven participants (3 males, 4 females) with other diseases that required them to be transfusion dependent. At the time of abstract submission, 1 participant has completed his “N-of-1” study. For this one individual, analysis comparing the pooled results of the four fresh blood transfusions versus the pooled results of the four standard issue blood transfusions was done. No significant difference was seen between fresh blood transfusions versus standard blood transfusions for all of the FACT-An parameters and post-transfusion Hb levels.

Improving QoL is an essential component in the management of chronic diseases such as the myelodysplastic syndromes. We have designed a series of “N-of-1” studies to detect a potential difference between fresh versus standard issue red blood cells. The preliminary data from a single participant who has completed this “N-of-1” study suggest that there is no significant difference in QoL measures and Hb levels. The study has fully enrolled and demonstrated the feasibility of this novel approach to evaluating the clinical benefits of transfusion. To our knowledge this is the first reported “N-of-1” study in transfusion.

No relevant conflicts of interest to declare.