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Damage control resuscitation (DCR) is emerging as a standard practice in civilian and military trauma care. Primary objectives include resolution of immediate life threats followed by optimization of physiological status in the perioperative period. To accomplish this, DCR employs a unique hypotensive hemostatic resuscitation strategy that avoids traditional crystalloid intravenous fluids in favor of early blood component use in ratios mimicking whole blood. The presence of uncontrolled major hemorrhage (UMH) coupled with a delay in access to hemostatic surgical intervention remains a primary contributor to preventable death in both combat and in many domestic settings, including rural areas and disaster sites. As a result, civilian and military emergency care leaders throughout the world have sought a means to project DCR principles forward of the traditional trauma resuscitation bay, into such remote environments as disaster scenes, rural health facilities, and the contemporary battlefield. After reflecting on experiences from past conflicts, defining current capability gaps, and examining available and potential solutions, a strategy for remote damage control resuscitation (RDCR) has been proposed. In order for RDCR to progress from concept to clinical strategy, it will be necessary to define existing gaps in knowledge and clinical capability; develop a lexicon so that investigators and operators may understand each other; establish coherent research and development agendas; and execute comprehensive investigations designed to predict, diagnose, and mitigate the consequences of hemorrhagic shock and acute traumatic coagulopathy before they become irreversible.

Background Little information is available regarding blood supply safety in Afghanistan. The purpose of this study was to assess blood safety through serologic and observational measures in Afghanistan. Study Design and Methods This cross-sectional assessment included the 40 highest-volume facilities collecting and transfusing blood nationally identified in a previous survey. At each facility, study representatives completed a standardized instrument assessing staff performance of transfusion-related activities and performed rapid testing for human immunodeficiency virus, syphilis, and hepatitis B and C with rapid diagnostic tests on clinically discarded specimens. Reactive samples received confirmatory testing. Descriptive statistics were generated, with differences analyzed using chi-square or Fisher's exact tests. Results Between November 2010 and May 2011, a total of 332 blood donor collection procedures were observed. Only 52.4% of observed encounters correctly screened and deferred donors by international criteria. Public and private facilities demonstrated glove use, proper sharps disposal, and patient counseling and relayed screening test results in less than 75% of observed events, significantly less likely than military facilities (p

_3770 505..517 BACKGROUND: Emergency whole blood transfusion is a lifesaving procedure employed on modern battlefields. Rapid device tests (RDTs) are frequently used to mitigate transfusion-transmitted infection risks. STUDY DESIGN AND METHODS: A limited evaluation of the RDT formerly used on battlefields was performed using 50 donor plasma samples and commercially available panels. Five hepatitis C virus (HCV) RDTs with sufficient stated sensitivity and thermostability were assessed using 335 HCV-positive and 339 HCVnegative donor plasma samples, 54 seroconversion panel plasma samples, and 84 HCV-positive and 84 HCV-negative spiked whole blood under normal, hot, and cold storage conditions and normal and hot test conditions, plus an ease-of-use survey. RESULTS: BioRapid HCV test sensitivity on donor plasma was 84% (95% confidence interval [CI], 70.9%92.8%). Using all positive plasma samples, OraQuick HCV sensitivity exceeded all comparators (99.4%, 95% CI, 98.0%-99.9%, p < 0.05). Specificity was consistently high, led by OraQuick HCV at 99.7% (95% CI, 98.6%-100%), statistically superior only to Axiom HCV (p < 0.05). Using seroconversion panels, only OraQuick HCV showed equivalent or earlier HCV detection compared to the gold standard. Using spiked whole blood, specificity was consistently high, and sensitivity ranged significantly from 34.5% (95% CI, 25.0%-45.1%) for CORE HCV to 98.8% (95% CI, 94.3%-99.9%) for OraQuick HCV. All comparator RDTs were significantly

BACKGROUND: The purpose of this study was to assess functionality and resources of facilities providing blood collection and transfusion services in Afghanistan. STUDY DESIGN AND METHODS: This national cross-sectional assessment included facilities collecting or transfusing blood identified through official data sources and private key informants. At each facility, study representatives completed a standardized instrument assessing presence of records logbook, electricity, refrigeration, and required transfusion-transmitted infection (TTI; human immunodeficiency virus, syphilis, and hepatitis B and C) test kits. Descriptive statistics were generated, with differences analyzed using chi-square or Fisher's exact tests. RESULTS: Between August and November 2010, a total of 243 facilities were surveyed with public (52.3%, n = 127) and private (43.2%, n = 105) sector comprising the majority. Most (63%) facilities were urban, with 23.5% located in Kabul province. Of 92,682 units collected nationally in the 12 months before evaluation, 7.5% (n = 6952) had no disposition record. Many (62%, n = 151) facilities had an established recordkeeping system; the remainder provided estimates. Half of surveyed facilities had regular power supply (57.8%), refrigerators for storing blood (52.3%), or all necessary TTI test kits (62.1%). Military (83.3%) and public (74.8%) facilities were more likely to have all TTI test kits present compared to private (46.7%, p

BACKGROUND: Blood operations are constrained by many limitations in combat settings. As a result there are many challenges that require innovative solutions. STUDY DESIGN AND METHODS: This is a descriptive overview of blood product usage and transfusion medicine adaptations that have been employed by the US military to support combat operations in Iraq and Afghanistan between November 2001 and December 2010. RESULTS: Transfusion medicine challenges have included the need for rapid transport of large quantities of blood products from the United States to Iraq and Afghanistan, risks and appropriate countermeasures associated with blood products collected in the theater of operations, availability of fresh-frozen plasma at forward surgical facilities, need for platelets (PLTs) in combat, and the need to support constant and evolving changes in transfusion and resuscitation protocols. A decrease in the storage age of red blood cells (RBCs) transfused to combat casualties has been achieved. There has been an increase in the ratio of plasma and PLTs to RBCs transfused, increased availability of plasma and apheresis PLTs to facilitate this approach, and a continuous effort to improve the safety of using fresh whole blood and apheresis PLTs collected in combat. A number of clinical practice guidelines are in place to address these processes. CONCLUSION: This multidisciplinary approach has successfully addressed many complicated and challenging issues regarding blood operations and transfusion practices for combat casualties.

BACKGROUND: Current US military clinical practice guidelines permit emergency transfusions of non–Food and Drug Administration (FDA)-compliant freshly collected blood products in theaters of war. This investigation aimed to characterize the risks of transfusion-transmitted infections (TTIs) associated with battlefield transfusions of non–FDA-compliant blood products. STUDY DESIGN AND METHODS: US Service members who received emergency transfusion products in Iraq and Afghanistan (March 1, 2002-September 30, 2007) were tested for hepatitis C virus (HCV), human immunodeficiency virus (HIV), and hepatitis B virus (HBV) infections using reposed pre- and posttransfusion sera. Selected regions of viral genomes from epidemiologically linked infected recipients and their donors were sequenced and compared. RESULTS: Of 761 US Service members who received emergency transfusion products, 475 were tested for HCV, 472 for HIV, and 469 for HBV. One transfusion-transmitted HCV infection (incidence rate of 2.1/1000 persons) was identified. The pretransfusion numbers (prevalence per 1000 persons) were HCV—four (8/1000), HIV—zero (0/1000), chronic HBV—two (4 /1000), and naturally immune (antibody to HBV core antigen)—nine (19/1000). CONCLUSION: One HCV TTI was determined to be associated with emergency blood product use. The pretransfusion HCV and HBV prevalence in transfusion recipients, themselves members of the potential donor population, indicates better characterization of the deployed force's actual donor population, and further investigations of the TTI prevalence in these donors are needed. These data will inform countermeasure development and clinical decision making.

BACKGROUND: At major combat hospitals, the military is able to provide blood products to include apheresis platelets (aPLT), but also has extensive experience using fresh whole blood (FWB). In massively transfused trauma patients, we compared outcomes of patients receiving FWB to those receiving aPLT. STUDY DESIGN AND METHODS: This study was a retrospective review of casualties at the military hospital in Baghdad, Iraq, between January 2004 and December 2006. Patients requiring massive transfusion (≥10 units in 24 hr) were divided into two groups: those receiving FWB (n = 85) or aPLT (n = 284) during their resuscitation. Admission characteristics, resuscitation, and survival were compared between groups. Multivariate regression analyses were performed comparing survival of patients at 24 hours and at 30 days. Secondary outcomes including adverse events and causes of death were analyzed. RESULTS: Unadjusted survival between groups receiving aPLT and FWB was similar at 24 hours (84% vs. 81%, respectively; p = 0.52) and at 30 days (60% versus 57%, respectively; p = 0.72). Multivariate regression failed to identify differences in survival between patients receiving PLT transfusions either as FWB or as aPLT at 24 hours or at 30 days. CONCLUSIONS: Survival for massively transfused trauma patients receiving FWB appears to be similar to patients resuscitated with aPLT. Prospective trials will be necessary before consideration of FWB in the routine management of civilian trauma. However, in austere environments where standard blood products are unavailable, FWB is a feasible alternative.

BACKGROUND: Treatment of blood products with riboflavin and light has been used to reduce the number of certain pathogens. Orientia (formerly Rickettsia) tsutsugamushi, the scrub typhus agent, is an obligate intracellular bacterium that grows free in the cytoplasm of infected cells. This study evaluated the capability of riboflavin and light to inactivate O. tsutsugamushi in red blood cells (RBCs), platelets (PLTs), and plasma, as measured by mouse infectivity. STUDY DESIGN AND METHODS: A total of 108 mice, equally divided into groups receiving RBCs, plasma, and PLTs, received untreated products infected with 100 to 105 organisms. Eighteen mice received products infected with 105 organisms and were subsequently treated with riboflavin and light. Mice were monitored daily for up to 17 days for signs and symptoms of infection (e.g., lethargy, labored breathing, rough coat) and killed upon appearance of symptoms or on Day 17 after infection. Real-time polymerase chain reaction (PCR) on blood and Giemsa stains from peritoneal exudates were performed. RESULTS: A total of 102 of 108 mice receiving the untreated products developed signs and symptoms of infection and had positive PCR and Giemsa stain results. None of the 18 animals receiving riboflavin and light–treated blood products exhibited signs or symptoms of infection, nor was infection observed by PCR testing or Giemsa staining. CONCLUSIONS: Riboflavin and light are effective in reducing O. tsutsugamushi. Mice injected with blood products inoculated with 105 organisms and treated with riboflavin and light did not experience any signs or symptoms of infection, 17 days after inoculation. A 5-log reduction of this organism in blood was achieved as assayed in an animal model.

BACKGROUND: An automated cell processing system (ACP 215, Haemonetics Corp.) can be used for the glycerolization and deglycerolization of RBC components, but the components must be 6 or fewer days old. Depending on the anticoagulant (CP2D)/additive solution (AS) used, deglycerolized RBCs can be stored at 1 to 6°C for up to 14 days. This study evaluated in vitro variables of apheresis RBC stored for 6 and 14 days at 1 to 6°C before glycerolization and 14 days after deglycerolization. STUDY DESIGN AND METHODS: Two units of CP2D/AS-3 leukoreduced RBCs were collected by apheresis from seven donors. One unit was glycerolized and frozen 6 days and the other 14 days after collection. All units were deglycerolized with the ACP 215 and stored at 1 to 6°C for 14 days in AS-3. Several in vitro variables were evaluated during postdeglycerolization storage. RESULTS: All components had postdeglycerolization RBC recoveries greater than 81 percent and osmolalities of less than 400 mOsm per kg. No significant differences were noted in potassium and supernatant hemoglobin after 14 days of postdeglycerolization storage between RBCs frozen at 6 and 14 days after collection. After 14 days of postdeglycerolization storage, however, the pH, lactate, and ATP levels were slightly lower in RBCs frozen after 14 days. CONCLUSION: The ACP 215 can be used to glycerolize and deglycerolize apheresis RBC components that are up to 14 days of age. It is likely that apheresis components glycerolized at 14 days of age or less can be stored up to 14 days in AS-3 after deglycerolization, but this should be confirmed with in vivo survival studies.

Background and Objectives Leishmania is transmitted by the bite of the phlebotomine sandfly or by transfusion of infected blood products. Leishmaniasis currently poses a significant problem in several parts of the world, and is an emerging problem in others. The Mirasol PRT technology is based on the use of riboflavin and ultraviolet light to generate chemical reactions in the nucleic acids of pathogens, which prevents replication and leads to inactivation. The intent of this study was to examine the ability of the Mirasol PRT System to kill the Leishmania parasite in human plasma and platelet concentrates. Materials and Methods In visceral Leishmaniasis, amastigotes are present in the blood and in the reticuloendothelial system within monocytes. For each unit of plasma or platelets treated, isolated mononuclear cells obtained from 100 ml of normal donor whole blood were incubated with 1·0 × 108Leishmania donovani infantum promastigotes to produce amastigote-laden macrophages. The infected macrophages were added to 250 ml of human plasma or to 250 ml of platelet concentrates. Infected units were cultured pretreatment in 10-fold serial dilutions to determine the limits of detection. Thirty millilitres of 500 µm riboflavin was added to each unit, which was then illuminated with 5·9 J/cm2 of ultraviolet light (6·24 J/ml). After treatment and after 2 months of frozen storage, plasma units were cultured in 10-fold serial dilutions. Platelets were cultured on the day of treatment and on day 5 of storage post-illumination. Results A 5 log reduction of Leishmania was demonstrated in five of six units of plasma, and a 7 log reduction of Leishmania was demonstrated in one plasma unit. A 5 log reduction of Leishmania was demonstrated in five of six units of platelets, and a 6 log reduction of Leishmania was demonstrated in one unit. Conclusions There is no donor screen for Leishmania and other pathogens constantly emerging in our blood supply. The Mirasol PRT System for Platelets and Plasma is an effective means of killing Leishmania and other emerging pathogens in these blood products.

BACKGROUND: In late January 2003, some blood centers and hospitals throughout the US voluntarily sus-pended the use of some RBC and plasma units for trans-fusion due to the presence of unknown white particulate matter (WPM) in these units. To better understand the WPM phenomena, a number of technologies were used to establish the nature of the particulates observed in Terumo Collection sets. STUDY DESIGN AND METHODS: All AS-5 nonleuko-reduced RBCs and plasma units were visually inspected for WPM by placing the bags on a flat counter, undisturbed, for approximately 10 minutes and then perform-ing a visual examination for particles. Particles were isolated and placed on microscope slides or in plastic tubes for further analysis. Electron microscopy, bright field microscopy, differential interference contrast microscopy, infrared spectroscopy, and flow cytometry procedures were performed to establish the nature of the particulate matter. In addition, leukoreduction filters and blood transfusion sets were used on RBCs units with WPM. RESULTS: The particles were mostly composed of PLTs and WBCs, and fragments of these cells. All macroscopic WPM was removed from RBCs with leukoeduction and transfusion filters. CONCLUSIONS: WPM originated from PLTs and WBCs. Foreign matter (e.g., plastic) was not observed in any of the units. Leukoreduction and transfusion filters can be used to remove macroscopic WPM.

Background There is a universal need, in both civilian and military settings, for a lightweight container capable of maintaining RBCs at 1 to 10 degrees C in remote areas, during extended transit times, and under austere environments. The use of ice in insulated containers or small commercial coolers for these purposes often results in loss of RBCs due to failure to maintain temperatures within the requisite range. A lightweight and thermally efficient container capable of carrying 4 to 6 units of RBCs at 1 to 10 degrees C for over 72 hours under extreme conditions would help resolve current problems in RBC transportation. Study design and methods Six different prototype containers incorporating phase-change materials (PCMs) in their designs were evaluated for their ability to maintain RBCs between 1 and 10 degrees C while exposed to external temperatures of -24 degrees C and 40 degrees C. In separate experiments, a container was opened and a RBC unit removed. Results One container weighing 10 pounds with four units of RBCs was capable of maintaining the temperature of the units between 1 and 10 degrees C for over 78 hours, 96 hours, and 120 hours at 40 degrees C, -24 degrees C, and 23 degrees C, respectively. Opening the container decreased these times by 2 to 3 hours. Conclusions An energy-efficient and lightweight container that maintains RBCs at 1 to 10 degrees C under austere environments for over 78 hours is now available. This container, known as the Golden Hour container (GHC), will facilitate transport of RBCs. The GHC will have additional applications (transport and/or storage of vaccines, other biologics, organs, reagents, etc).

Background The United States introduced human T-lymphotropic virus Type I (HTLV-I) screening of blood donors in 1988. The US military uses freshly collected blood products for life-threatening injuries when available stored blood components in theater have been exhausted or when these components are unsuccessful for resuscitation. These donors are screened after donation by the Department of Defense (DoD) retrospective testing program. All recipients of blood collected in combat are tested according to policy soon after and at 3, 6, and 12 months after transfusion. Case Report A 31-year-old US Army soldier tested positive for HTLV-I 44 days after receipt of emergency blood transfusions for severe improvised explosive device blast injuries. One donor's unit tested HTLV-I positive on the DoD-mandated retrospective testing. Both the donor and the recipient tested reactive with enzyme immunoassay and supplemental confirmation by HTLV-I Western blot. The donor and recipient reported no major risk factors for HTLV-I. Phylogenetic analysis of HTLV-I sequences indicated Cosmopolitan subtype, Subgroup B infections. Comparison of long terminal repeat and env sequences revealed molecular genetic linkage of the viruses from the donor and recipient. Conclusion This case is the first report of transfusion transmission of HTLV-I in the US military during combat operations. The emergency fresh whole blood policy enabled both the donor and the recipient to be notified of their HTLV-I infection. While difficult in combat, predonation screening of potential emergency blood donors with Food and Drug Administration–mandated infectious disease testing as stated by the DoD Health Affairs policy should be the goal of every facility engaged with emergency blood collection in theater.