IVL may involve the pituitary gland, causing sellar mass effect, cavernous sinus infiltration, and pituitary ischemia, mimicking pituitary apoplexy with neuro-ophthalmic features. It can be effectively treated with CHOP-R chemotherapy.

4411 Introduction: 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. Methods: 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. Results: 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. Conclusions: 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. Disclosures: No relevant conflicts of interest to declare.

In chronically transfused patients, there were no significant differences in HRQL or Hb levels between fresh versus standard blood. While larger trials are needed, these results support current practices in hospital blood transfusion laboratories using a first-in, first-out model of blood utilization for these transfusion-dependent patients. Use of n-of-1 trials to determine the benefits of transfusions in single patients appears to be feasible.

3369 Introduction Red blood cell concentrates (RBCs) are stored for up to 42 days. Prolonged storage of RBCs results in “the storage lesion” which has been associated with adverse outcomes in patients with critical illness, sepsis, and post-cardiac surgery. No studies have assessed the impact of the storage lesion on the quality of life (QoL) of patients who require chronic transfusion support. This study assessed the effects of fresh versus standard issue blood on QoL and follow-up hemoglobin (Hb) in transfusion-dependent patients. Methods Transfusion-dependent patients age 18 years or older, were invited to participate in an N-of-1 trial. Transfusion dependence required at least one unit of RBCs every four weeks. Each participant was randomly assigned four fresh (less than seven days of storage) and four standard issue (seven to 42 days of storage) blood transfusions. Investigators, study participants, treating physicians, and nurses were blinded to product allocation. A questionnaire containing a visual analog scale (VAS) and the Functional Assessment of Cancer Therapy-Anemia questionnaire (FACT-An) was completed prior to and 24 hours after each transfusion. Changes were calculated as post-transfusion scores minus pre-transfusion scores. Hemoglobin levels were measured at each subsequent transfusion. Within-subject (each participant) between-treatment comparisons of QoL scores and hemoglobin levels were assessed by unpaired t-tests among participants who completed at least six transfusions. Between-group changes in QoL scores for all participants were assessed by paired t-tests and a mixed model approach. Results Twenty patients were enrolled (mean age 66.8 years, 12 females). Underlying diagnoses included myelodysplastic syndromes (12), β-thalassemia (3), myeloproliferative neoplasms (3), Diamond-Blackfan anemia (1), and chronic anemia of undetermined etiology (1). Mean ages of fresh and standard blood were 4.0 days and 23.2 days, respectively. Nine participants completed at least six transfusions. Among remaining participants, nine were non-compliant, and two died. All data were analysed in the between-group comparisons. There were no statistically significant differences in the effect of standard blood and fresh blood on the eight QoL parameters assessed in all analyses. This was seen in the within subject between-group analysis as well as the between-group analysis. Similarly, there were no statistically significant differences in the effect of standard blood and fresh blood on follow-up Hb levels. Conclusions No significant differences in QoL parameters or follow-up Hb levels were observed in patients receiving fresh versus standard issue blood. These results suggest that local blood transfusion laboratory practices do not need to be altered for transfusion-dependent patient populations. To our knowledge, this is the first study to assess the QoL effects of age of blood on transfusion-dependent patients using N-of-1 trials. While larger studies are needed to confirm these findings, our results demonstrate that N-of-1 studies are feasible and informative in the management of individual patients. The randomized controlled multiple crossover design of N-of-1 studies may be also useful in addressing questions in transfusion medicine regarding differences in the quality of blood products. Disclosures: No relevant conflicts of interest to declare.