Stubbs, James R.

Importance Patients undergoing cardiac surgery with cardiopulmonary bypass often require platelet transfusions for bleeding. Platelets are routinely stored at room temperature (20-24 °C) for up to 5 to 7 days; however, cold storage (1-6 °C) may allow for increased storage duration without loss of hemostatic function. Objective To determine the maximum cold-storage duration, up to 21 days, for which cold-stored platelets (CSPs) are noninferior or superior in hemostatic efficacy to room-temperature platelets (RTPs) when transfused in actively bleeding patients undergoing cardiac surgery with cardiopulmonary bypass. Design, Setting, and Participants A phase 3, multicenter, randomized, partially blinded, adaptive, noninferiority, storage duration–ranging trial conducted in pediatric and adult patients undergoing cardiac surgery with planned cardiopulmonary bypass at 27 sites in the US and Australia from December 2021 to March 2025. Statistical analysis was conducted from September 9 to October 3, 2025. Intervention Patients were randomized 2:1 to receive CSPs with a maximum of 21 days of storage vs RTPs with a maximum of 7 days of storage. Main Outcomes and Measures The primary outcome was a hemostatic efficacy score with values ranging from 1 to 5 and higher values indicating greater bleeding. The noninferiority margin was 1 point. The success criterion was met if at least 1 cold-storage duration of 7 days or more had a posterior probability of noninferiority of at least 97.5%. The secondary outcome was 24-hour chest tube output. Results Of the 1000 patients who underwent platelet transfusion, 989 were included in the primary analysis (650 CSPs and 339 RTPs). The cohort had a mean (SD) age of 42.1 (30.1) years and 67.8% were male. CSPs were noninferior to RTPs for the primary outcome, with a probability of greater than 99.9% for all cold-storage durations. Pooled across storage durations, CSPs had a mean difference from RTPs of 0.09 (95% credible interval, −0.06 to 0.23). Median (IQR) chest tube output at 24 hours (8.9 mL/kg [5.2-15.4] for CSPs vs 8.4 mL/kg [5.5-15.9] for RTPs; difference in medians, 0.4 [95% CI, −1.0 to 1.5]) was not statistically different between study groups. In a post hoc analysis, as all storage durations were noninferior, considering the CSPs as a single group, the hemostatic efficacy score was similar between both groups: mean (SD) of 3.08 (1.15) CSPs vs 2.99 (1.10) RTPs. There were no differences in venous or arterial thrombotic events, transfusion-associated adverse events, acute respiratory distress syndrome, kidney failure, septic shock, and mortality between the study groups, except for increased reexploration rates in the CSP group. Conclusions and Relevance For patients undergoing cardiac surgery, CSPs stored up to 21 days are noninferior to RTPs for the control of active surgical bleeding. Use of CSPs may allow for increased availability of platelets by reducing wastage and shortages and may allow for incorporation of platelets into inventory at locations where platelets cannot be maintained due to the 5- to 7-day shelf life of RTPs. Trial Registration ClinicalTrials.gov Identifier: NCT04834414

Background ‘Exception from informed consent’ research requires community consultation to ensure that the views of the local population have been considered. Using market research companies to distribute surveys across local populations is attractive because it ensures adequate response rates. It is not known whether individuals who respond to surveys are typical of the targeted communities. The purpose of this study is to compare the demographics of the survey respondents with that of the general population in the same area. Methods This is an analysis of data collected as part of the ‘Trauma Resuscitation with Group O Whole Blood or Products’ (TROOP) trial. The surveys used a commercial market research service to reach the communities of interest and consisted of 18 questions designed to evaluate respondents’ willingness to be enrolled in the TROOP trial and the demographics of survey respondents. Results Catchment populations varied from 0.5 to 9.4 million residents, with a total of 33.5 million. The racial and ethnic composition of the population (and the survey respondents, in brackets) was 44.8% (57.0%) white, 25.7% (13.4%) Hispanic, 12.7% (19.4%) black, 8.0% (2.5%) multiracial, 7.9% (4.4%) Asian, 0.7% (0.9%) Native American, and 0.2% (0.5%) Islanders. Of the male population (and survey respondents, in brackets), 12.2% (15.3%) were aged 18years to 24 years, 20.5% (22.3%) aged 25 years to 34 years, 18.1% (24.9%) aged 35 years to 44 years, 16.3% (18.5%) aged 45 years to 54 years, 15.5% (14.8%) aged 55 years to 64 years, and 17.4% (4.3%) aged 65 years and over. Of the female population (and survey respondents, in brackets), 11.0% (18.5%) were aged 18 years to 24 years, 18.4% (22.6%) aged 25 years to 34 years, 16.4% (23.5%) aged 35 years to 44 years, 15.0% (17.3%) aged 45 years to 54 years, 18.5% (14.1%) aged 55 years to 64 years, and 20.6% (3.9%) aged 65 years and over. Conclusions For this trial, using a market research company to distribute community surveys resulted in respondents that are broadly representative of the geographic areas where the trial will be conducted, except for individuals over the age of 65 years and older. This finding provides reassurance to investigators and institutional review boards that the views expressed by respondents are representative of the population where the trial will be conducted. Level of evidence III

AbstractBackgroundRecently the US Food and Drug Administration has granted variances to select blood centers to supply cold‐stored platelet components (CSP). In hemorrhage resuscitation warming of blood components with approved fluid warming devices is common.Study Design and MethodsPathogen‐reduced apheresis platelet units were collected and stored in one of two ways: (1) CSP‐I, (2) CSP‐D. CSP‐I were collected and immediately stored at 1–6°C until used. CSP‐D were collected and stored at 20–24°C for 5 days and transferred to storage at 1–6°C until use. Aggregometry using arachidonic acid (AA), adenosine diphosphate (ADP) and collagen as agonists was performed on the unit samples before and after the units were infused through a Ranger blood‐warming device.ResultsCSP‐I, 23 units, had very high aggregation responses to all agonists (all ≥47.6 ± 20.7). There was a statistically significant reduction in ADP‐induced aggregometry results from 55.1 ± 23.2 before compared to 33.5 ± 14.6 following infusion of the PLT through the blood warmer (p < .001). There were no differences in AA and collagen aggregometry results before and after the infusion of the platelets through the blood warmer. CSP‐D had 5 of the 15 units with visible clotting in the bag. The 10 CSP‐Ds studied had lower aggregation than all agonists before and after infusion through the blood‐warming device (all ≤49.9 ± 35.9).ConclusionWe detected a statistically significant reduction in ADP‐induced aggregometry in CSP‐I run through a Ranger blood‐warming device with no change with AA or collagen agonist aggregometry.

Background Delayed cold storage of room temperature platelets may extend shelf life from 5 to 14 days. The study hypothesized that the use of delayed cold-stored platelets in cardiac surgery would be associated with decreased postoperative platelet count increments but similar transfusion and clinical outcomes compared to room temperature-stored platelets. Methods This is an observational cohort study of adults transfused with platelets intraoperatively during elective cardiac surgery between April 2020 and May 2021. Intraoperative platelets were either room temperature-stored or delayed cold-stored based on blood bank availability rather than clinical features or provider preference. Differences in transfusion and clinical outcomes, including a primary outcome of allogenic transfusion exposure in the first 24 h postoperatively, were compared between groups. Results A total of 713 patient encounters were included: 529 (74%) room temperature-stored platelets and 184 (26%) delayed cold-stored platelets. Median (interquartile range) intraoperative platelet volumes were 1 (1 to 2) units in both groups. Patients receiving delayed cold-stored platelets had higher odds of allogeneic transfusion in the first 24 h postoperatively (81 of 184 [44%] vs. 169 of 529 [32%]; adjusted odds ratio, 1.65; 95% CI, 1.13 to 2.39; P = 0.009), including both erythrocytes (65 of 184 [35%] vs. 135 of 529 [26%]; adjusted odds ratio, 1.54; 95% CI, 1.03 to 2.29; P = 0.035) and platelets (48 of 184 [26%] vs. 79 of 529 [15%]; adjusted odds ratio, 1.91; 95% CI, 1.22 to 2.99; P = 0.005). There was no difference in the number of units administered postoperatively among those transfused. Platelet counts were modestly lower in the delayed cold-stored platelet group (−9 × 109/l; 95% CI, −16 to −3]) through the first 3 days postoperatively. There were no significant differences in reoperation for bleeding, postoperative chest tube output, or clinical outcomes. Conclusions In adults undergoing cardiac surgery, delayed cold-stored platelets were associated with higher postoperative transfusion utilization and lower platelet counts compared to room temperature-stored platelets without differences in clinical outcomes. The use of delayed cold-stored platelets in this setting may offer a viable alternative when facing critical platelet inventories but is not recommended as a primary transfusion approach. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

AbstractBackgroundPrevious studies have demonstrated low first‐time donor return rates (DRR) following catastrophic events. Little is known, however, about the influence of demographic factors on the DRR of first‐time donors during the COVID‐19 pandemic, including the unique motivation of COVID‐19 convalescent plasma (CCP) donors as compared to non‐CCP donors.Study Design and MethodsThirteen blood collection organizations submitted deidentified data from first‐time CCP and non‐CCP donors returning for regular (non‐CCP) donations during the pandemic. DRR was calculated as frequencies. Demographic factors associated with returning donors: race/ethnicity, gender, and generation (Gen Z: 19–24, Millennial: 25–40, Gen X: 41–56, and Boomer: ≥57 years old), within the CCP and non‐CCP first‐time cohorts were compared using chi‐square test at p < .05 statistical significance.ResultsFrom March 2020 through December 2021, there were a total of 44,274 first‐time CCP and 980,201 first‐time non‐CCP donors. DRR were 14.6% (range 11.9%–43.3%) and 46.6% (range 10.0%–76.9%) for CCP and non‐CCP cohorts, respectively. Age over 40 years (Gen X and Boomers), female gender, and White race were each associated with higher return in both donor cohorts (p < .001). For the non‐CCP return donor cohort, the Millennial and Boomers were comparable.ConclusionThe findings demonstrate differences in returning donor trends between the two donor cohorts. The motivation of a first‐time CCP donor may be different than that of a non‐CCP donor. Further study to improve first‐time donor engagement would be worthwhile to expand the donor base with a focus on blood donor diversity emphasizing engagement of underrepresented minorities and younger donors.

Abstract The platelet collection and distribution system, based on volunteer nonremunerated donors, apheresis platelet collections, and primarily 1-directional distribution of platelets for up to 5-day room temperature storage at hospitals, typically performs well and provides therapeutic support for hundreds of thousands of patients annually. However, direct and indirect effects of the coronavirus disease 2019 pandemic, particularly during the Omicron wave, produced dramatic systemic failures and severe shortages. We propose 4 initiatives to reinforce the existing platelet pipeline and buffer the platelet supply against future unexpected disruptions.

AbstractBackgroundA specialized international multidisciplinary group of investigators wanted to determine the performance and impact of publications presented at an annual conference over a 6 year period. Specifically, the group wanted to know if the influence of the conference publications extended beyond conference publication authors and attendees. Bibliometric methods and network analyses were used to evaluate the performance and impact of 100 peer‐reviewed publications presented at the Trauma Hemostasis and Oxygenation Research (THOR) Network Remote Damage Control Resuscitation (RCDR) Symposia from 2012 to 2017 (published 2013–2018). Further analysis was performed on the affiliations of conference attendees who attended from the years of 2012 to 2017.Study Design and MethodsThis project used normative and relative bibliometric measures and social network analysis to evaluate the performance and impact of 100 peer‐reviewed publications presented at the Trauma Hemostasis and Oxygenation Research (THOR) Network RDCR Symposia from 2012 to 2017. Publication and citation data were from Elsevier Scopus, a bibliographic citation database. Metrics from Elsevier SciVal were selected for the project to normalize for group size, year of publication, and document type. A six‐year period of publications presented at the Symposia, published from 2013 to 2018, was selected for analysis. The publication and citation data were further analyzed using Elsevier SciVal and the iCite database from the National Institutes of Health Office of Portfolio Analysis. Sci2, VOSviewer, and Gephi were used for social network analyses and visualization.ResultsThe 100 publications presented at the Trauma Hemostasis and Oxygenation Research (THOR) Network Remote Damage Control Resuscitation (RCDR) Symposia from 2012 to 2017 demonstrate reach and influence beyond the authors of the THOR publications or the THOR attendees. Citations to the THOR publications were published in 10 languages and 313 unique journals, with author affiliations from 62 countries. Citation metrics for the THOR publications exceed global averages with 65% of the THOR publications being in the 25% citation percentiles. When benchmarking the THOR publications using six homogenous comparator groups, the THOR publications demonstrate higher citation metrics than any of the comparator groups with more citations per publication, a higher average of cited publications, higher FWCI and outputs in the top citation percentiles among the six groups. The Office of Portfolio Analysis (OPA) iCite database was used to calculate potential to translate for the THOR publications with 57 of the THOR publications cited by clinical articles with an average approximate potential to translate score of 65.3%.ConclusionsThe value of international groups with sharing of research and knowledge are instrumental in enhancing the uptake for best practices for in medicine and treatment of hemorrhagic shock resuscitation. The use of bibliometric methods and network analyses, along with benchmarking, demonstrated reach and impact beyond the THOR Network. Limitations include use of a single source for analysis of publication and citation; and that publication data alone does not provide a full overview of research performance. Despite these limitations, bibliometric methods, social network analyses, and benchmarking can help centers better understand their impact.