Change in Bone Mineral Density among High Frequency Apheresis Blood Donors

Exposure to citrate anticoagulant during apheresis blood donation induces significant decreases in serum ionized calcium with subsequent perturbations to parathyroid hormone, vitamin D, and markers of bone remodeling. Cross-sectional studies of bone mineral density (BMD) among apheresis donors exhibit conflicting results. Resolving the potential impact of the highest apheresis donation frequency represents a significant knowledge gap in ensuring adequate protections for volunteer apheresis blood donors. ALTRUYST (NCT02655055) was a randomized, longitudinal, controlled clinical trial designed to determine if repeated exposure to citrate through apheresis donation reduces BMD. Male donors, 18-65 years of age with no more than five previous apheresis donations and no diseases of bone or mineral metabolism, agreed to make ≥20 apheresis donations in the subsequent one year period. Dual-energy x-ray absorptiometry was performed at baseline and again after one year of participation. Paired t-test was used to assess change in mean BMD. Donors in the apheresis arm (n=26) made a median of 20 donations (range 4–22 donations) during the one-year study period with a mean donation interval of 17.8 days. Controls (n=15) made zero apheresis donations and a median of two whole-blood donations (range 0-6). Mean lumbar spine BMD at the end of the study period did not differ significantly from that at the beginning among donors in the control arm (mean change=-0.002 g/cm2, 95% CI [-0.020, 0.016], p=0.78), nor did it change significantly among donors in the apheresis arm (mean change=0.007 g/cm2, CI [-0.005, 0.018], p=0.24). Change in mean BMD at the total hip was not statistically significant for control donors (mean change=0.002 g/cm2, CI [-0.006, 0.009], p=0.63) or apheresis donors (-0.004 g/cm2, CI [-0.10, 0.002], p=0.16). Tests for differences in proportions of donors with change in BMD exceeding the least significant change (LSC) at the lumbar spine (0.00743 ±0.02058g/cm2) between the apheresis and control arms in either a positive [apheresis 13 (50%), control 5 (33%), p=0.84] or negative direction [apheresis 8 (31%), control 6 (40%)] were statistically non-significant (p=0.87). Proportional increases [apheresis 6 (23%), control 6 (40%), p=0.25] and decreases [apheresis 11 (42%), control 3 (20%)] were not significantly different (p=0.15) at the total hip (LSC=0.00671±0.01859g/cm2)

Impact of frequent apheresis blood donation on bone density: A prospective,longitudinal, randomized, controlled trial

Background Blood for transfusion is lifesaving and essential to many elements of modern medical practice. The global blood supply relies on volunteer blood donors. Apheresis is increasingly used to collect blood and requires anticoagulant to prevent extracorporeal coagulation. Citrate, the standard apheresis anticoagulant, chelates ionized calcium with consequent perturbations of serum calcium, parathyroid hormone, vitamin D, and markers of bone remodeling in donors. Cross-sectional studies of bone mineral density (BMD) among apheresis donors exhibit conflicting results. Methods The longitudinal, randomized, controlled ALTRUYST trial (NCT02655055) was undertaken to determine whether BMD declined following high frequency apheresis blood donation over 1 year. The study was powered at 80% to detect the primary outcome of a 3% decline in BMD. Subjects new to apheresis agreed to make ≥20 apheresis donations in a one-year period and were randomized to treatment (high frequency apheresis) or control (no apheresis). Dual-energy x-ray absorptiometry was performed before and after participation. Two-sided t-test and multivariable logistic regression were used to assess outcomes. Findings Mean lumbar spine BMD did not change during the study among control donors (−0.002 g/cm2, 95%CI [−0.020, 0.016], p = 0.78), or among donors in the apheresis arm (mean change = 0.007 g/cm2, 95%CI [−0.005, 0.018], p = 0.24). Mean total hip BMD did not change for control donors (mean change = 0.002 g/cm2, 95%CI [−0.006, 0.009], p = 0.63) or apheresis donors (−0.004 g/cm2, 95%CI [−0.10, 0.002], p = 0.16). Tests for differences in proportions of donors with change in BMD exceeding the least significant change at the lumbar spine in either a positive [8 apheresis (31%), 4 control (27%), p = 0.78] or negative direction [4 apheresis (15%), 5 control (33%)] were statistically non-significant (p = 0.18). Proportional increases [0 apheresis (0%), 1 control (7%), p = 0.18] and decreases [3 apheresis (12%), 1 control (14%)] were also not significantly different at the total hip (p = 0.61). Interpretation ALTRUYST is the first longitudinal trial to demonstrate that apheresis blood collection guidelines in the United States adequately protect the skeletal health of male volunteer blood donors

The epidemiology of platelet transfusions: an analysis of platelet use at 12 US hospitals.

BackgroundUsing the Recipient and Donor Epidemiology Study-III (REDS-III) recipient and donor databases, we performed a retrospective analysis of platelet use in 12 US hospitals that were participants in REDS-III.Study design and methodsData were electronically extracted from participating transfusion service and blood center computer systems and from medical records of the 12 REDS-III hospitals. All platelet transfusions from 2013 to 2016 given to patients aged 18 years and older were included in the analysis.ResultsThere were 28,843 inpatients and 2987 outpatients who were transfused with 163,719 platelet products (103,371 apheresis, 60,348 whole blood derived); 93.5% of platelets were leukoreduced and 72.5% were irradiated. Forty-six percent were transfused to patients with an International Classification of Diseases, 9th/10th Revision (ICD-9/10) diagnosis of leukemia, myelodysplastic syndrome (MDS), or lymphoma. The general ward and the intensive care unit (ICU) were the most common issue locations. Only 54% of platelet transfusions were ABO identical; and 60.6% of platelet transfusions given to Rh-negative patients were Rh positive. The most common pretransfusion platelet count range for inpatients was 20,000 to 50,000/μL, for outpatients it was 10,000 to 20,000/μL. Among ICU patients, 35% of platelet transfusion episodes had a platelet count of greater than 50,000/μL; this was only 8% for general ward and 2% for outpatients. The median posttransfusion increment, not corrected for platelet dose and/or patient size, ranged from 12,000 to 20,000/μL for inpatients, and from 17,000 to 27,000/μL for outpatients.ConclusionsThese data from one of the largest reviews of platelet transfusion practice to date provide guidance for where to focus future clinical research studies and platelet blood management programs

Equivalent inpatient mortality among direct-acting oral anticoagulant and warfarin users presenting with major hemorrhage

BackgroundExtrapolation of clinical trial results comparing warfarin and direct-acting oral anticoagulant (DOAC) users experiencing major hemorrhage to clinical care is challenging due to differences seen among non-randomized oral anticoagulant users, bleed location, and etiology. We hypothesized that inpatient all-cause-mortality among patients presenting with major hemorrhage differed based on the home-administered anticoagulant medication class, DOAC versus warfarin.MethodsMore than 1.5 million hospitalizations were screened and 3731 patients with major hemorrhage were identified in the REDS-III Recipient Database. Propensity score matching and stratification were used to account for potentially confounding factors.ResultsInpatient all-cause-mortality was lower for DOAC (HR = 0.60, 95%CI 0.45-0.80, p = 0.0005) before accounting for confounding and competing events. Inpatient all-cause-mortality for 1266 propensity-score-matched patients compared using proportional hazards regression did not differ (HR = 0.84, 95%CI 0.58-1.22, p = 0.36). Inpatient all-cause-mortality in stratified analyses (warfarin as reference) produced: HR = 0.69 (95%CI 0.31-1.55) for traumatic head injuries; HR = 1.10 (95%CI 0.62-1.95) for non-traumatic head injuries; HR = 0.62 (95%CI 0.20-1.94) for traumatic, non-head injuries; and HR = 0.69 (95%CI 0.29-1.63) for non-traumatic, non-head injuries. Mean time to discharge was shorter for DOAC (HR = 1.17, 95%CI 1.05-1.30, p = 0.0034) in the propensity score matched analysis. Plasma transfusion occurred in 42% of warfarin hospitalizations and 11% of DOAC hospitalizations. Vitamin K was administered in 63% of warfarin hospitalizations.ConclusionsAfter accounting for differences in patient characteristics, location of bleed, and traumatic injury, inpatient survival was no different in patients presenting with major hemorrhage while on DOAC or warfarin

Demographic and epidemiologic characterization of transfusion recipients from four US regions: evidence from the REDS-III recipient database.

BACKGROUND:Blood transfusion is one of the most common medical procedures during hospitalization in the United States. To understand the benefits of transfusion while mitigating potential risks, a multicenter database containing detailed information on transfusion incidence and recipient outcomes would facilitate research. STUDY DESIGN AND METHODS:The Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) program has developed a comprehensive transfusion recipient database utilizing data from hospital electronic health records at 12 participating hospitals in four geographic regions. Inpatient and outpatient data on transfusion recipients from January 1, 2013 to December 31, 2014 included patient age, sex, ethnicity, primary diagnosis, type of blood product provided, issue location, pretransfusion and post-transfusion hemoglobin (Hgb), and hospital outcomes. Transfusion incidence per encounter was calculated by blood product and various patient characteristics. RESULTS:During the 2-year study period, 80,362 (12.5%) inpatient encounters involved transfusion. Among inpatients, the most commonly transfused blood products were red blood cells (RBCs; 10.9% of encounters), followed by platelets (3.2%) and plasma (2.9%). Among patients who received transfusions, the median number of RBC units was one, the pretransfusion Hgb level was 7.6 g/dL, and the Hgb increment per unit was 1.4 g/dL. Encounter mortality increased with patient age, the number of units transfused, and the use of platelet or plasma products. The most commonly reported transfusion reaction was febrile nonhemolytic. CONCLUSION:The database contains comprehensive data regarding transfusion use and patient outcomes. The current report describes an evaluation of the first 2 years of a planned, 4-year, linked blood donor-component-recipient database, which represents a critical new resource for transfusion medicine researchers

The Theia "Digital Soil Mapping" Scientific Expertise Centre of France

International audienc

The Theia “Digital Soil Mapping” Scientific Expertise Centre of France

International audiencepas de résum

The Theia “Digital Soil Mapping” Scientific Expertise Centre of France

International audiencepas de résum