Time to treatment matters in traumatic haemorrhage but the optimal prehospital use of blood in major trauma remains uncertain. We investigated whether use of packed red blood cells (PRBC) and ...lyophilised plasma (LyoPlas) was superior to use of 0·9% sodium chloride for improving tissue perfusion and reducing mortality in trauma-related haemorrhagic shock.
Resuscitation with pre-hospital blood products (RePHILL) is a multicentre, allocation concealed, open-label, parallel group, randomised, controlled, phase 3 trial done in four civilian prehospital critical care services in the UK. Adults (age ≥16 years) with trauma-related haemorrhagic shock and hypotension (defined as systolic blood pressure <90 mm Hg or absence of palpable radial pulse) were assessed for eligibility by prehospital critial care teams. Eligible participants were randomly assigned to receive either up to two units each of PRBC and LyoPlas or up to 1 L of 0·9% sodium chloride administered through the intravenous or intraosseous route. Sealed treatment packs which were identical in external appearance, containing PRBC–LyoPlas or 0·9% sodium chloride were prepared by blood banks and issued to participating sites according to a randomisation schedule prepared by the co-ordinating centre (1:1 ratio, stratified by site). The primary outcome was a composite of episode mortality or impaired lactate clearance, or both, measured in the intention-to-treat population. This study is completed and registered with ISRCTN.com, ISRCTN62326938.
From Nov 29, 2016 to Jan 2, 2021, prehospital critical care teams randomly assigned 432 participants to PRBC–LyoPlas (n=209) or to 0·9% sodium chloride (n=223). Trial recruitment was stopped before it achieved the intended sample size of 490 participants due to disruption caused by the COVID-19 pandemic. The median follow-up was 9 days (IQR 1 to 34) for participants in the PRBC–LyoPlas group and 7 days (0 to 31) for people in the 0·9% sodium chloride group. Participants were mostly white (62%) and male (82%), had a median age of 38 years (IQR 26 to 58), and were mostly involved in a road traffic collision (62%) with severe injuries (median injury severity score 36, IQR 25 to 50). Before randomisation, participants had received on average 430 mL crystalloid fluids and tranexamic acid (90%). The composite primary outcome occurred in 128 (64%) of 199 participants randomly assigned to PRBC–LyoPlas and 136 (65%) of 210 randomly assigned to 0·9% sodium chloride (adjusted risk difference –0·025% 95% CI –9·0 to 9·0, p=0·996). The rates of transfusion-related complications in the first 24 h after ED arrival were similar across treatment groups (PRBC–LyoPlas 11 7% of 148 compared with 0·9% sodium chloride nine 7% of 137, adjusted relative risk 1·05 95% CI 0·46–2·42). Serious adverse events included acute respiratory distress syndrome in nine (6%) of 142 patients in the PRBC–LyoPlas group and three (2%) of 130 in 0·9% sodium chloride group, and two other unexpected serious adverse events, one in the PRBC-LyoPlas (cerebral infarct) and one in the 0·9% sodium chloride group (abnormal liver function test). There were no treatment-related deaths.
The trial did not show that prehospital PRBC–LyoPlas resuscitation was superior to 0·9% sodium chloride for adult patients with trauma related haemorrhagic shock. Further research is required to identify the characteristics of patients who might benefit from prehospital transfusion and to identify the optimal outcomes for transfusion trials in major trauma. The decision to commit to routine prehospital transfusion will require careful consideration by all stakeholders.
National Institute for Health Research Efficacy and Mechanism Evaluation.
Whole Blood Transfusion Cap, Andrew P; Beckett, Andrew; Benov, Avi ...
Military medicine,
09/2018, Volume:
183, Issue:
suppl_2
Journal Article
Peer reviewed
Open access
Whole blood is the preferred product for resuscitation of severe traumatic hemorrhage. It contains all the elements of blood that are necessary for oxygen delivery and hemostasis, in nearly ...physiologic ratios and concentrations. Group O whole blood that contains low titers of anti-A and anti-B antibodies (low titer group O whole blood) can be safely transfused as a universal blood product to patients of unknown blood group, facilitating rapid treatment of exsanguinating patients. Whole blood can be stored under refrigeration for up to 35 days, during which it retains acceptable hemostatic function, though supplementation with specific blood components, coagulation factors or other adjuncts may be necessary in some patients. Fresh whole blood can be collected from pre-screened donors in a walking blood bank to provide effective resuscitation when fully tested stored whole blood or blood components are unavailable and the need for transfusion is urgent. Available clinical data suggest that whole blood is at least equivalent if not superior to component therapy in the resuscitation of life-threatening hemorrhage. Low titer group O whole blood can be considered the standard of care in resuscitation of major hemorrhage.
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DOBA, IZUM, KILJ, NUK, ODKLJ, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK, VSZLJ
ABSTRACTIn past and ongoing military conflicts, the use of whole blood (WB) as a resuscitative product to treat trauma-induced shock and coagulopathy has been widely accepted as an alternative when ...availability of a balanced component-based transfusion strategy is restricted or lacking. In previous military conflicts, ABO group O blood from donors with low titers of anti-A/B blood group antibodies was favored. Now, several policies demand the exclusive use of ABO group–specific WB. In this short review, we argue that the overall risks, dangers, and consequences of “the ABO group–specific approach,” in emergencies, make the use of universal group O WB from donors with low titers of anti-A/B safer. Generally, risks with ABO group–specific transfusions are associated with in vivo destruction of the red blood cells transfused. The risk with group O WB is from the plasma transfused to ABO-incompatible patients. In the civilian setting, the risk of clinical hemolytic transfusion reactions (HTRs) due to ABO group–specific red blood cell transfusions is relatively low (approximately 1:80,000), but the consequences are frequently severe. Civilian risk of HTRs due to plasma incompatible transfusions, using titered donors, is approximately 1:120,000 but usually of mild to moderate severity. Emergency settings are often chaotic and resource limited, factors well known to increase the potential for human errors. Using ABO group–specific WB in emergencies may delay treatment because of needed ABO typing, increase the risk of clinical HTRs, and increase the severity of these reactions as well as increase the danger of underresuscitation due to lack of some ABO groups. When the clinical decision has been made to transfuse WB in patients with life-threatening hemorrhagic shock, we recommend the use of group O WB from donors with low anti-A/B titers when logistical constraints preclude the rapid availability of ABO group–specific WB and reliable group matching between donor and recipient is not feasible.
Whole blood is the original blood preparation but disappeared from the blood bank inventories in the 1980s following the advent of component therapy. In the early 2000s, both military and civilian ...practice called for changes in the transfusion support for massive haemorrhage. The ‘clear fluid’ policy was abandoned and replaced by early balanced transfusion of platelets, plasma and red cells. Whole blood is an attractive alternative to multi‐component therapy, which offers reduced hemodilution, lower donor exposure and simplified logistics. However, the potential for wider re‐introduction of whole blood requires re‐evaluation of haemolysins, storage conditions and shelf‐life, the need for leucocyte depletion/ pathogen reduction and inventory management for blood providers. This review addresses these questions and calls for research to define the optimal whole blood product and the indications for its use.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UILJ, UKNU, UL, UM, UPUK
Damage Control Resuscitation Cap, Andrew P; Pidcoke, Heather F; Spinella, Philip ...
Military medicine,
09/2018, Volume:
183, Issue:
suppl_2
Journal Article
Peer reviewed
Open access
Damage control resuscitation (DCR) is a strategy for resuscitating patients from hemorrhagic shock to rapidly restore homeostasis. Efforts are focused on blood product transfusion with whole blood or ...component therapy closely approximating whole blood, limited use of crystalloid to avoid dilutional coagulopathy, hypotensive resuscitation until bleeding control is achieved, empiric use of tranexamic acid, prevention of acidosis and hypothermia, and rapid definitive surgical control of bleeding. Patients receiving uncrossmatched Type O blood in the emergency department and later receiving cumulative transfusions of 10 or more red blood cell units in the initial 24-hour post-injury (massive transfusion) are widely recognized as being at increased risk of morbidity and mortality due to exsanguination. Ideally, these patients should be rapidly identified, however anticipating transfusion needs is challenging. Useful indicators of massive transfusion reviewed in this guideline include: systolic blood pressure <110 mmHg, heart rate > 105 bpm, hematocrit <32%, pH < 7.25, injury pattern (above-the-knee traumatic amputation especially if pelvic injury is present, multi-amputation, clinically obvious penetrating injury to chest or abdomen), >2 regions positive on Focused Assessment with Sonography for Trauma (FAST) scan, lactate concentration on admission >2.5, admission international normalized ratio ≥1.2-1.4, near infrared spectroscopy-derived StO2 < 75% (in practice, rarely available), BD > 6 meq/L. Unique aspects of out-of-hospital DCR (point of injury, en-route, and remote DCR) and in-hospital (Medical Treatment Facilities: Role 2b/Forward surgical teams - role 3/ combat support hospitals) are reviewed in this guideline, along with pediatric considerations.
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DOBA, IZUM, KILJ, NUK, ODKLJ, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK, VSZLJ
Transfusion support is an essential element of modern emergency healthcare. Blood services together with hospital transfusion teams are required to prepare for, and respond to, mass casualty events ...as part of wider healthcare emergency planning. Preparedness is a constant collaborative process that actively identifies and manages potential risks, to prevent such events becoming a ‘disaster’. The aim of transfusion support during incidents is to provide sufficient and timely supply of blood components and diagnostic services, whilst maintaining support to other patients not involved in the event.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Noncompressible hemorrhage is the leading cause of potentially preventable battlefield death. Combining casualty retrieval from the battlefield and damage control resuscitation (DCR) within the ..."golden hour" increases survival. However, transfusion requirements may exceed the current blood component stocks held by forward surgical teams. Warm fresh whole blood (WFWB) is an alternative. We report WFWB transfusion training developed by and delivered to a US Golden Hour Offset Surgical Treatment Team and the resulting improvement in confidence with WFWB transfusion.
A bespoke instructional package was derived from existing operational clinical guidelines. All Golden Hour Offset Surgical Treatment Team personnel completed initial training, reinforced through ongoing casualty simulations. A record of blood types and donor eligibility was established to facilitate rapid identification of potential WFWB donors. Self-reported confidence in seven aspects of the WFWB transfusion process was assessed before and after training using a five-point Likert scale. Personnel were analyzed by groups consisting of those whose operational role includes WFWB transfusion ("transfusers"), clinical personnel without such responsibilities ("nontransfusers") and nonclinical personnel (other). Comparisons within and between groups were made using appropriate nonparametric tests.
Data were collected from 39 (89%) of 44 training participants: 24 (62%) transfusers, 12 (31%) nontransfusing clinicians, and 3 (8%) other personnel. Transfusers and nontransfusers reported increased comfort with all practical elements of WFWB transfusion. The confidence of other personnel also increased, but (likely due to small numbers) was not statistically significant.
WFWB transfusion is an integral part of modern deployed military remote DCR. Our in-theater training program rapidly and reproducibly enhanced the comfort in WFWB transfusion in providers from a range of backgrounds and skill-mixes. This model has the potential to improve both safety and effectiveness of WFWB remote DCR in the far-forward deployed setting.
Therapeutic/care management study, level IV.
Background
The treatment of traumatic haemorrhagic shock has been transformed through better haemorrhage control, use of tranexamic acid and use of blood products. The improved survival seen from ...these strategies has stimulated an interest in pre-hospital transfusion.
Objectives
To determine if the clinical effectiveness of resuscitation with red blood cells and lyophilised plasma was superior to 0.9% saline for improving tissue perfusion and reducing mortality in adults with haemorrhagic shock following major trauma.
Design
A multi-centre, allocation concealed, open-label, parallel group, randomised controlled trial (with internal pilot).
Setting
The trial was conducted in four civilian pre-hospital critical care services who operated within the National Health Service (NHS) England Major Trauma Networks.
Participants
Adults (aged ≥16 years) who had sustained traumatic injuries, were attended by a pre-hospital emergency medical team and were hypotensive (systolic blood pressure <90 mmHg or absence of radial pulse) as a consequence of traumatic haemorrhage were eligible for inclusion. The exclusion criteria were known or apparently <16 years, blood administered on scene prior to arrival of the RePHILL team, traumatic cardiac arrest where (1) the arrest occurred prior to arrival of the team and/or (2) the primary cause is not hypovolaemia, refusal of blood product administration, known Jehovah’s Witness, pregnancy, isolated head injury without evidence of external haemorrhage, prisoners in the custody of HM Prison and Probation Service.
Interventions
Participants were randomised to receive up to either two units each of red blood cells and lyophilised plasma or up to 1 L 0.9% saline. Treatment was administered through the intravenous or intraosseous route.
Main outcome measures
The primary outcome was a composite of episode mortality and/or impaired lactate clearance. The secondary outcomes included the individual components of the primary outcome.
Results
From 6 December 2016 to 2 January 2021, pre-hospital medical teams randomised 432 participants to red blood cell/lyophilised plasma (
n
= 209) or 0.9% saline (
n
= 223) out of a target sample size of 490. Most participants were white (62%), males (82%), median age 38 (interquartile range 26 to 58), involved in a road traffic collision (62%) with severe injuries (median injury severity score 36, interquartile range 25 to 50). Prior to randomisation participants had received on average 430 ml crystalloid fluids and tranexamic acid (90%). The primary outcome occurred in 128/199 (64.3%) of participants randomised to red blood cell/lyophilised plasma and 136/210 (64.8%) randomised to 0.9% saline adjusted risk difference –0.025% (95% confidence interval –9.0% to 9.0%),
p
= 0.996. The event rates for the individual components of the primary outcome, episode mortality and lactate clearance were not statistically different between groups adjusted average differences −3% (−12% to 7%);
p
= 0.57 and −5% (−14% to 5%),
p
= 0.33, respectively.
Limitations
Recruitment stopped prematurely due to disruption caused by the COVID-19 pandemic.
Future work
Identify the characteristics of patients who may benefit from pre-hospital blood products and whether alternative transfusion regimens are superior to standard care.
Conclusions
The trial did not demonstrate that pre-hospital red blood cell/lyophilised plasma resuscitation was superior to 0.9% saline for trauma-related haemorrhagic shock.
Trial registration
This trial is registered as ISRCTN62326938.
Funding
This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation Programme (NIHR award ref: 14/152/14) and is published in full in
Efficacy and Mechanism Evaluation
; Vol. 11, No. 2. See the NIHR Funding and Awards website for further award information.
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