Key Points Question Do 1 or more doses of levocarnitine reduce organ failure in septic shock at 48 hours, and, if so, what is the likelihood of success in a phase 3 trial? Findings In an adaptive randomized, blinded clinical trial of 250 adults, the most efficacious dose of levocarnitine (18 g) demonstrated a posterior probability of efficacy of 0.78, which did not reach the a priori threshold of 0.90. Meaning L evocarnitine did not meaningfully reduce organ failure at 48 hours in patients with septic shock.
Rural and minority populations are underrepresented in clinical research, likely because of travel barriers and financial resources required to participate in conventional studies. 1 Digital technology holds promise to improve access to clinical studies, 2 but limited evidence is available detailing the adoption of these methods in underserved populations. We describe our experience using digital technology for remote enrollment in a clinical study evaluating the use of home blood pressure (BP) telemonitoring for hypertension management.Methods | This prospective study at the University of Mississippi Medical Center (UMMC) used data for participants enrolled from September 4, 2018, through September 19, 2019. The study protocol was approved by the UMMC institutional review board. Adult patients with hypertension and uncontrolled BP who were receiving outpatient care at UMMC were eligible for study inclusion.Potential participants were identified by referral and review of the electronic health record. Following a screening telephone call, interested individuals meeting eligibility criteria were mailed a telemonitoring kit, including an electronic tablet with prepaid secure broadband connectivity, wireless BP cuff, and institutional review board-approved consent document. There were no costs incurred by study participants. The consent document was written at an eighth-grade reading level using lay terminology and formatted to facilitate clear understanding of the content. After receiving the kit, the research coordinator (K.J.) contacted the participant via the tablet for an audiovisual encounter. During the audiovisual encounter, personal identifying information was confirmed and the consent form reviewed, with the ability to screen-share the document in real time. The research coordinator, who was well versed in the cultural exigencies of this patient population, addressed any questions or concerns. Informed consent was authorized by the participant by agreeing to a confirmatory statement displayed on the tablet, which generated a time and date electronic stamp transmitted to the individual's electronic health record. The research coordinator documented the encounter in the electronic health record, including a description of the consent process. If the individual declined to participate, the kit was returned at no cost to the participant in a prepaid shipping box. Data analysis was completed with Excel version 16.0.12624 (Microsoft).Results | Among 100 enrolled participants, the mean (SD) age was 59.6 (11.1) years; 54 participants (54%) were female, and 45 (45%) were African American (Table ). Twenty-three par-
Background Age, race, and gender differences in coagulation status of healthy volunteers have been reported in previous case series; however, rigorous multivariate analysis adjusting for these factors is lacking. We aimed to investigate the effects of age, race, and gender on baseline coagulation status in healthy volunteers. Methods Thirty healthy volunteer controls with no history of bleeding or thrombotic events and no previous anticoagulant or antiplatelet use were recruited. Citrated and heparinized blood samples were drawn, and kaolin and platelet-mapping thromboelastography (TEG) assays performed. Results Thirty participants had a mean age of 37, mean body mass index of 29 kg/m2, and were 47% African-American and 70% female. Women were significantly older than men (40 ± 11 y vs 28 ± 7 y, P = .002); there were no significant differences in demographics by race. Multivariate analysis of variance for the effect of age, race, and gender across TEG parameters yielded evidence for gender differences in hypercoagulability (Pillai’s trace P = .02), which appear to be driven by differences in K-time, alpha angle, maximal amplitude, and G parameter. Women were hypercoagulable compared to men, as manifested by shorter K-time, steeper alpha angle, higher maximal amplitude, and larger G parameter. Discussion Women at baseline have relatively hypercoagulable fibrin deposition kinetics, platelet contributions to clot formation, and overall clot strength compared to men, even when adjusted for age and race. Additional research is needed to specifically detail the key patient-level factors, clinical implications, and opportunities for tailored therapy related to gender-associated hypercoagulability.
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