SummaryBackgroundInfluenza causes significant morbidity and mortality despite currently available treatments. Anecdotal reports suggest plasma with high antibody titers towards influenza may be of benefit in the treatment of severe influenza.MethodsWe conducted a randomized, open-label, multicenter phase 2 trial at 29 academic medical centers in the United States to assess the safety and efficacy of anti-influenza plasma with hemagglutination inhibition (HAI) antibody titers of ≥ 1:80 to the infecting strain. Hospitalized children and adults (including pregnant women) with severe influenza A or B (defined as hypoxia or tachypnea) were randomly assigned to receive either 2 units (or pediatric equivalent) of anti-influenza plasma plus standard care (P+S), versus standard care alone (S), and were followed for 28 days. The primary endpoint was time to normalization of patients’ respiratory status (respiratory rate of ≤ 20 for adults or age defined thresholds of 20–38 for children), and a room air saturation of oxygen ≥ 93%. ClinicalTrials.gov Identifier: NCT01052480FindingsBetween January 13, 2011 and March 2, 2015, 113 participants were screened, and 98 were randomized. Of the participants with confirmed influenza, 28 of 42 (67%) of P+S participants normalized their respiratory status by Day 28, as compared to 24 of 45 (53%) of S participants (p=0·069). The estimated hazard ratio comparing P+S to S was 1·71 (95% CI: 0·96 to 3·06). Six participants died, 1 (2%) and 5 (10%) from the P+S and S arms respectively (p=0·093). P+S participants had non-significant reductions in days in hospital (median 6 vs. 11 days, p=0·13) and days on mechanical ventilation (median 0 vs. 3 days, p=0·14), and significantly improved clinical status at Day 7 (p=0·020). Fewer P+S participants experienced SAEs compared to S recipients (20% vs. 38%, p= 0·041), the most frequent of which were acute respiratory distress syndrome (1 [2%] vs 2 [4%]) and stroke (1 [2%] vs 2 [4%]).InterpretationResults from this Phase II randomized trial of immune plasma for the treatment of severe influenza provides support for a possible benefit of immunotherapy across the primary and secondary endpoints. A Phase III randomized trial is now underway to further evaluate this intervention.
Background The Pragmatic Randomized Optimal Platelets and Plasma Ratios (PROPPR) trial was a randomized clinical trial comparing survival after transfusion of 2 different blood component ratios for emergency resuscitation of traumatic massive hemorrhage. Transfusion services supporting the study were expected to provide thawed plasma, platelets and red blood cells within 10 minutes of request. Study Design and Methods At the 12 Level 1 trauma centers participating in PROPPR, blood components transfused and delivery times were tabulated, with a focus on universal donor (UD) plasma management. The adequacy of site plans was assessed by comparing the bedside blood availability times to study goals and the new American College of Surgeons (ACS) guidelines. Results Eleven of 12 sites were able to consistently deliver 6 units of thawed UD plasma to their trauma receiving unit within 10 minutes, and 12 units in 20 minutes. Three sites used blood group A plasma instead of AB for massive transfusion without complications. Approximately 4700 units of plasma were given to the 680 patients enrolled in the trial. No site experienced shortages of AB plasma that limited enrollment. Two of 12 sites reported wastage of thawed AB plasma approaching 25% of AB plasma prepared. Conclusion Delivering UD plasma to massively hemorrhaging patients was accomplished consistently, rapidly and without excessive wastage in high-volume trauma centers. The ACS Trauma Quality Improvement Program guidelines for massive transfusion protocol UD plasma availability are practicable in large academic trauma centers. Use of group A plasma in trauma resuscitation needs further study.
Background In contrast to standard donor retention strategies (e.g., mailings, phone calls, text messages), we developed a brief telephone interview, based on motivational interviewing principles, which encourages blood donors to reflect upon their unique motivators and barriers for giving. The present study examined the effect of this motivational interview, combined with action and coping plan components, on blood donor motivations. Study Design and Methods The design was to randomly assign blood donors to receive either a telephone-delivered motivational interview with action and coping plan components or a control call approximately six weeks after their most recent donation. Participants completed a series of surveys related to donation motivation approximately 3 weeks before telephone contact (pre-call baseline) and then repeated these surveys approximately one week after telephone contact (post-call). Results The sample was 63% female, included a majority (52.6%) first-time blood donors, and had a mean age of 30.0 years (SD = 11.7). A series of ANOVAs revealed that, relative to controls (n=244), donors in the motivational interview group (n=254) had significantly larger increases in motivational autonomy (p=0.001), affective attitude (p=0.004), self-efficacy (p=0.03), anticipated regret (p=0.001), and intention (p=<0.001), as well as larger decreases in donation anxiety (p=0.01), from pre-call baseline to post-call assessment. Conclusion This study supports motivational interviewing with action and coping planning as a novel strategy to promote key contributors to donor motivation.
This article examines Black churches as therapeutic systems that provide psychological and physical support to African American communities. Systems theory and group relations theory are used as conceptual frameworks to discuss Black churches as indigenous community resources. Instrumental to a systems approach is an understanding of Black churches and the religious experiences they support as part of a dynamic process that may vary across churches while maintaining certain basic similarities. It is also important to explore how Black churches may function differently from one another in addressing the needs of their membership and surrounding community. Consequently, a group process perspective is used to examine how roles and functions of the church may vary as they relate to their particular congregation. Examining the role of Black churches as supportive networks provides invaluable information to professional health providers who are interested in working with Black churches as community-based organizations.
OBJECTIVE: The transfusion of older packed red blood cells (PRBC) may be harmful in critically ill patients. We sought to determine the association between PRBC age and mortality among trauma patients requiring massive PRBC transfusion. Competing interests: JRH receives patent royalties from the United States Army and the University of Maryland for improved red blood cell storage solutions. The rest of the authors declare that they have no competing interests.
There is wide variability in immunohematology testing and RBC selection practices for patients who have WAAs (with or without AIHA). Future studies are needed to evaluate and compare the effectiveness of different testing algorithms and transfusion strategies.
Background Based on the hypothesis that self-determined motivation is associated with an increased likelihood of future behavior, the present study examined the ability of a motivational interview to promote internal motivation for giving and future donation attempts. Study Design and Methods A sample of 484 recent whole blood and double red cell donors (62.4% female; mean age = 30.2, SD = 11.8 years) were randomly assigned to either a telephone-delivered motivational interview or a control call approximately six weeks after donating. Several weeks before the call and again one week after the call participants completed the Blood Donor Identity Survey, a multidimensional measure of donor motivation, to derive indices of amotivation, external motivation, and internal motivation to give blood. Repeat donation attempts were tracked using blood center records. Results Relative to controls, participants in the motivational interview group showed a shift toward more self-determined motivation as indicated by significant decreases in amotivation (p=0.01) and significant increases in external (p=0.009) and internal motivation (p=0.002). Further, those with initially high levels of autonomous motivation were more likely to make a donation attempt in the subsequent year if they completed the motivational interview (71.1%) versus the control call (55.1%). Conclusion Motivational interviewing is a potentially useful strategy to enhance retention of existing blood donors, particularly among those who express a greater sense of internal motivation for giving.
First-time blood donors are essential to the US donor pool, providing nearly a third of all donations. Unfortunately, there are a wide variety of obstacles to repeat donation and new donors are extremely difficult to retain. Because each donor experiences a unique set of deterrents, we developed a post-donation interview based on motivational interview principles in order to flexibly address individual barriers. The primary aim of this randomized clinical trial is to examine retention of first-time, group O blood donors who are randomly assigned to receive either a telephone-delivered interview with motivational and action planning components or a standard-of-care control call approximately six weeks after their donation. Measures of donation attitude, perceived behavioral control, intention, and motivational autonomy will be measured before and after the telephone contact using online surveys, and donation attempts will be tracked for one year using blood center donor databases. We hypothesize that, compared to controls, donors who receive the telephone interview will be more likely to make a donation attempt over the following year. In addition, we will examine possible mechanisms of action of the interview using key predictors of donation behavior as described by Self Determination Theory (i.e., motivational autonomy) and the Theory of Planned Behavior (i.e., attitude, perceived behavioral control, and intention). Results of this intervention may help to support a novel strategy to enhance retention of selected blood donors in an effort to better meet the nation’s blood supply needs.
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