Results of clinical effectiveness of conventional versus Mirasol-treated Apheresis Platelets in Patients with Hypoproliferative Thrombocytopenia (MiPLATE) trial.

BACKGROUND: The Mirasol® Pathogen Reduction Technology System was developed to reduce transfusion-transmitted diseases in platelet (PLT) products. STUDY DESIGN AND METHODS: MiPLATE trial was a prospective, multicenter, controlled, randomized, non-inferiority (NI) study of the clinical effectiveness of conventional versus Mirasol-treated Apheresis PLTs in participants with hypoproliferative thrombocytopenia. The novel primary endpoint was days of ≥Grade 2 bleeding with an NI margin of 1.6. RESULTS: After 330 participants were randomized, a planned interim analysis of 297 participants (145 MIRASOL, 152 CONTROL) receiving ≥1 study transfusion found a 2.79-relative rate (RR) in the MIRASOL compared to the CONTROL in number of days with ≥Grade 2 bleeding (95% confidence interval [CI] 1.67-4.67). The proportion of subjects with ≥Grade 2 bleeding was 40.0% (n = 58) in MIRASOL and 30.3% (n = 46) in CONTROL (RR = 1.32, 95% CI 0.97-1.81, p = .08). Corrected count increments were lower (p < .01) and the number of PLT transfusion episodes per participant was higher (RR = 1.22, 95% CI 1.05-1.41) in MIRASOL. There was no difference in the days of PLT support (hazard ratio = 0.86, 95% CI 0.68-1.08) or total number of red blood cell transfusions (RR = 1.12, 95% CI 0.91-1.37) between MIRASOL versus CONTROL. Transfusion emergent adverse events were reported in 119 MIRASOL participants (84.4%) compared to 133 (82.6%) participants in CONTROL (p = NS). DISCUSSION: This study did not support that MIRASOL was non-inferior compared to conventional platelets using the novel endpoint number of days with ≥Grade 2 bleeding in MIRASOL when compared to CONTROL.

Novel method for determining when a field-collected donor unit is sufficiently full.

BACKGROUND: Whole blood (WB) collections can occur downrange for immediate administration. An important aspect of these collections is determining when the unit is sufficiently full. This project tested a novel method for determining when a field collection is complete. METHODS: The amount of empty space at the top of WB units, destined to become LTOWB or separated into components, that were collected at blood centers or hospitals was measured by holding a WB unit off the ground and placing the top of a piece of string where the donor tubing entered the bag. The string was marked where it intersected the top of the column of blood in the bag and measured from the top. The WB units were also weighed. RESULTS: A total of 15 different bags, two of which were measured in two different filling volumes, from 15 hospitals or blood centers were measured and weighed. The most commonly used blood bag, Terumo Imuflex SP, had a median string length of 9 mm (range: 2-24 mm) and weighed a median of 565.1 g (range: 524.8-636.7 g). CONCLUSION: Pieces of string can be precut to the appropriate length depending on the type of bag before a mission where field WB collections might be required and a mark placed on the bag before the collection commences to indicate when the unit is full.

Emergency preparedness for mass casualty events: South Texas commentary on the development of a statewide emergency response system.

Mass casualty incidents (MCIs) are on the rise in the USA, and hemorrhage is the leading cause of preventable death in trauma. The need for rapid access to life-saving blood and blood products is essential for preventing death due to hemorrhage. It is well established that most major cities in the USA are underprepared to meet blood transfusion requirements in the event of an MCI. The South Texas Whole Blood Consortium sought to rectify this and vowed to be prepared to provide low-titer type O-positive whole blood (LTOWB) and blood components to the people who need it, where and when they need it. This system was able to transport 25 units of LTOWB and packed red blood cells almost 100 miles away to Uvalde Memorial Hospital within just 67 minutes after notification of an active shooter. The regional consortium has created a pool of dedicated LTOWB donors affectionately called Heroes in Arms who can be called on to instantly augment locoregional blood supply. Previously pregnant women have historically been excluded from donating plasma and LTOWB due to the increased rates of human leukocyte antigen (HLA) antibody (Ab) positivity, which is associated with transfusion-related acute lung injury. However, the South Texas Blood and Tissue Center in San Antonio had a large number of qualified, previously pregnant females desire to join the Heroes in Arms program prompting them to assess the feasibility of providing HLA Ab testing for this demographic and the results were promising. This is the first report of previously pregnant women being included in the pool for donation of LTOWB.

Walking blood bank: a plan to ensure self-sufficiency in an era of blood shortage.

Mass casualty incidents and massive transfusion requirements continue to plague the USA with hemorrhage remaining the number one cause of death in trauma. The unfortunate reality of numerous mass shootings in Southwest Texas has led to the need for a way in which to provide blood during these events as rapidly as it is required. Multiple agencies within the Southwest Texas system have united to help provide this life-saving blood to people when they need it most. This effort began with the development of a system for safe, efficient, and now widespread use of whole blood in the region. After demonstrating the success of delivering large quantities of blood during the Uvalde shooting, we have begun to develop a walking blood bank that is similar to what the miliary uses on the battlefield. The concept behind this initiative is to have a cohort of whole blood donors who are preselected to join the program which is now dubbed 'Heroes in Arms'. These donors will be called upon to donate whole blood during a massive transfusion event. Their blood will be rapidly screened prior to transfusion to the patient. This blood will still undergo the normal rigorous testing and, should any potentially transmissible diseases by discovered post-transfusion, the individual who received that product will be treated accordingly. Given the low rate of transmissible disease among this preselected population, combined with rapid screening prior to transfusion, the risk of a person receiving a transmissible disease is insignificant in comparison to the benefit of having blood to transfuse during hemorrhage. This model is a promising collaborative effort to provide in a timely and sufficient blood product in cases of major need which will consequently minimize the number of traumatically injured civilian patients who die from hemorrhage.

In vitro quality parameters of whole blood-derived platelets pooled using two different platelet pooling sets and stored up to 7 days are similar.

BACKGROUND: Increasing the number of collections of whole blood-derived platelets (WBDP) and lengthening the allowable storage time may alleviate platelet (PLT) shortages. There is a need for new PLT pooling sets that can provide acceptable quality on Day 7 of storage. STUDY DESIGN AND METHODS: This pool-and-split study compared WBDP prepared using the platelet-rich plasma method with the novel IMUGARD WB PLT pooling set and a control pooling set. After pooling and filtration, PLT products were tested on Days 1, 5, and 7. Large volume delayed sampling (LVDS) cultures were taken on Day 2. RESULTS: The median postfiltration residual white blood cell (rWBC) content was 0.18 million per product (maximum 1.26 million; n = 69) with mean PLT recovery of 88.5 ± 2.8% for the new set and median 0.23 million (maximum 1.83 million) rWBC with 87.5 ± 2.5% recovery for the control. Day 5 mean pH22°C were 7.18 ± 0.12 and 7.13 ± 0.10 for the new and control set, respectively. Day 5 in vitro quality parameters were within 20% between the two pooling sets. The new set Day 7 pH22°C was acceptable (7.07 ± 0.17, 100% ≥ 6.3), and most parameters were within 20% of Day 5 values. CONCLUSION: WBDP quality for the new pooling set is acceptable across a battery of in vitro tests when stored up to 7 days and meets FDA regulatory criteria. The quality parameters were similar between the new pooling set and the control set on Day 5. This new set is compatible with LVDS.

Demographics of first-time donors returning for donation during the pandemic: COVID-19 convalescent plasma versus standard blood product donors.

BACKGROUND: Previous 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 METHODS: Thirteen 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. RESULTS: From 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. CONCLUSION: The 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.

The regional whole blood program in San Antonio, TX: A 3-year update on prehospital and in-hospital transfusion practices for traumatic and non-traumatic hemorrhage.

Low titer type O Rh-D + whole blood (LTO + WB) has become a first-line resuscitation medium for hemorrhagic shock in many centers around the World. Showing early effectiveness on the battlefield, LTO + WB is used in both the pre-hospital and in-hospital settings for traumatic and non-traumatic hemorrhage resuscitation. Starting in 2018, the San Antonio Whole Blood Collaborative has worked to provide LTO + WB across Southwest Texas, initially in the form of remote damage control resuscitation followed by in-hospital trauma resuscitation. This program has since expanded to include pediatric trauma resuscitation, obstetric hemorrhage, females of childbearing potential, and non-traumatic hemorrhage. The objective of this manuscript is to provide a three-year update on the successes and expansion of this system and outline resuscitation challenges in special populations.

Immunoglobulin M anti-A and anti-B titers in South Texas group O D+ male donors.

BACKGROUND: The success of whole blood (WB) in damage control resuscitation on the battlefield has generated interest in its use for civilian trauma. Blood centers must maintain a committed donor pool with low isoagglutinin titers to provide this product. Information regarding isoagglutinin titers in different donor populations will help with targeted recruitment of these donors. STUDY DESIGN AND METHODS: Sequential O D+ male donors with a history of two or more donations at a fixed site were tested for immunoglobulin (Ig)M anti-A and anti-B using a single titer cutoff of 256. Donors testing negative at this cutoff were considered "low titer" while positive donors were considered "high titer." Age and self-identified race/ethnicity were retrospectively obtained from the blood establishment computer system. Fisher's exact analysis was used for statistical analysis with a p value of less than 0.05 considered significant. RESULTS: Of 3274 donors, 426 tested as high titer, while 2848 tested as low titer. The data show an association of donor age and prevalence of high titers with older age groups showing a lower prevalence of high titers. In addition, different races/ethnicities have different prevalences of high titers with the Caucasian/white group showing a lower prevalence of high-titer donors versus the Hispanic and undeclared race groups. CONCLUSION: The prevalence of high-titer IgM anti-A or -B donors varies by age group and race/ethnicity in our data set. This information will provide information on what donor groups to target for collection of low-titer O WB.