IMPORTANCE: Severely injured patients experiencing hemorrhagic shock often require massive transfusion. Earlier transfusion with higher blood product ratios (plasma, platelets, and red blood cells), ...defined as damage control resuscitation, has been associated with improved outcomes; however, there have been no large multicenter clinical trials. OBJECTIVE: To determine the effectiveness and safety of transfusing patients with severe trauma and major bleeding using plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio. DESIGN, SETTING, AND PARTICIPANTS: Pragmatic, phase 3, multisite, randomized clinical trial of 680 severely injured patients who arrived at 1 of 12 level I trauma centers in North America directly from the scene and were predicted to require massive transfusion between August 2012 and December 2013. INTERVENTIONS: Blood product ratios of 1:1:1 (338 patients) vs 1:1:2 (342 patients) during active resuscitation in addition to all local standard-of-care interventions (uncontrolled). MAIN OUTCOMES AND MEASURES: Primary outcomes were 24-hour and 30-day all-cause mortality. Prespecified ancillary outcomes included time to hemostasis, blood product volumes transfused, complications, incidence of surgical procedures, and functional status. RESULTS: No significant differences were detected in mortality at 24 hours (12.7% in 1:1:1 group vs 17.0% in 1:1:2 group; difference, −4.2% 95% CI, −9.6% to 1.1%; P = .12) or at 30 days (22.4% vs 26.1%, respectively; difference, −3.7% 95% CI, −10.2% to 2.7%; P = .26). Exsanguination, which was the predominant cause of death within the first 24 hours, was significantly decreased in the 1:1:1 group (9.2% vs 14.6% in 1:1:2 group; difference, −5.4% 95% CI, −10.4% to −0.5%; P = .03). More patients in the 1:1:1 group achieved hemostasis than in the 1:1:2 group (86% vs 78%, respectively; P = .006). Despite the 1:1:1 group receiving more plasma (median of 7 U vs 5 U, P < .001) and platelets (12 U vs 6 U, P < .001) and similar amounts of red blood cells (9 U) over the first 24 hours, no differences between the 2 groups were found for the 23 prespecified complications, including acute respiratory distress syndrome, multiple organ failure, venous thromboembolism, sepsis, and transfusion-related complications. CONCLUSIONS AND RELEVANCE: Among patients with severe trauma and major bleeding, early administration of plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio did not result in significant differences in mortality at 24 hours or at 30 days. However, more patients in the 1:1:1 group achieved hemostasis and fewer experienced death due to exsanguination by 24 hours. Even though there was an increased use of plasma and platelets transfused in the 1:1:1 group, no other safety differences were identified between the 2 groups. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01545232
There is no consensus as to the optimal treatment paradigm for patients presenting with hemorrhage from severe pelvic fracture. This study was established to determine the methods of hemorrhage ...control currently being used in clinical practice.
This prospective, observational multi-center study enrolled patients with pelvic fracture from blunt trauma. Demographic data, admission vital signs, presence of shock on admission (systolic blood pressure < 90 mm Hg or heart rate > 120 beats per minute or base deficit < -5), method of hemorrhage control, transfusion requirements, and outcome were collected.
A total of 1,339 patients with pelvic fracture were enrolled from 11 Level I trauma centers. Fifty-seven percent of the patients were male, with a mean ± SD age of 47.1 ± 21.6 years, and Injury Severity Score (ISS) of 19.2 ± 12.7. In-hospital mortality was 9.0 %. Angioembolization and external fixator placement were the most common method of hemorrhage control used. A total of 128 patients (9.6%) underwent diagnostic angiography with contrast extravasation noted in 63 patients. Therapeutic angioembolization was performed on 79 patients (5.9%). There were 178 patients (13.3%) with pelvic fracture admitted in shock with a mean ± SD ISS of 28.2 ± 14.1. In the shock group, 44 patients (24.7%) underwent angiography to diagnose a pelvic source of bleeding with contrast extravasation found in 27 patients. Thirty patients (16.9%) were treated with therapeutic angioembolization. Resuscitative endovascular balloon occlusion of the aorta was performed on five patients in shock and used by only one of the participating centers. Mortality was 32.0% for patients with pelvic fracture admitted in shock.
Patients with pelvic fracture admitted in shock have high mortality. Several methods were used for hemorrhage control with significant variation across institutions. The use of resuscitative endovascular balloon occlusion of the aorta may prove to be an important adjunct in the treatment of patients with severe pelvic fracture in shock; however, it is in the early stages of evaluation and not currently used widely across trauma centers.
Prognostic study, level II; therapeutic study, level III.
AbstractObjective. Earlier use of plasma and red blood cells (RBCs) has been associated with improved survival in trauma patients with substantial hemorrhage. We hypothesized that prehospital ...transfusion (PHT) of thawed plasma and/or RBCs would result in improved patient coagulation status on admission and survival. Methods. Adult trauma patient records were reviewed for patient demographics, shock, coagulopathy, outcomes, and blood product utilization from September 2011 to April 2013. Patients arrived by either ground or two different helicopter companies. All patients transfused with blood products (either pre- or in-hospital) were included in the study. One helicopter system (LifeFlight, LF) had thawed plasma and RBCs while the other air (OA) and ground transport systems used only crystalloid resuscitation. Patients receiving PHT were compared with all other patients meeting entry criteria to the study cohort. All comparisons were adjusted in multilevel regression models. Results. A total of 8,536 adult trauma patients were admitted during the 20-month study period, of which 1,677 met inclusion criteria. They represented the most severely injured patients (ISS = 24 and mortality = 26%). There were 792 patients transported by ground, 716 by LF, and 169 on OA. Of the LF patients, 137 (19%) received prehospital transfusion. There were 942 units (244 RBCs and 698 plasma) placed on LF helicopters, with 1.9% wastage. PHT was associated with improved acid-base status on hospital admission, decreased use of blood products over 24 hours, a reduction in the risk of death in the sickest patients over the first 6 hours after admission, and negligible blood products wastage. In this small single-center pilot study, there were no differences in 24-hour (odds ratio 0.57, p = 0.117) or 30-day mortality (odds ratio 0.71, p = 0.441) between LF and OA. Conclusions. Prehospital plasma and RBC transfusion was associated with improved early outcomes, negligible blood products wastage, but not an overall survival advantage. Similar to the data published from the ongoing war, improved early outcomes are associated with placing blood products prehospital, allowing earlier infusion of life-saving products to critically injured patients.
Early identification of patients with pelvic fractures at risk of severe bleeding requiring intervention is critical. We performed a multi-institutional study to test our hypothesis that pelvic ...fracture patterns predict the need for a pelvic hemorrhage control intervention.
This prospective, observational, multicenter study enrolled patients with pelvic fracture due to blunt trauma. Inclusion criteria included shock on admission (systolic blood pressure <90 mm Hg or heart rate >120 beats/min and base deficit >5, and the ability to review pelvic imaging). Demographic data, open pelvic fracture, blood transfusion, pelvic hemorrhage control intervention (angioembolization, external fixator, pelvic packing, and/or REBOA resuscitative balloon occlusion of the aorta), and mortality were recorded. Pelvic fracture pattern was classified according to Young-Burgess in a blinded fashion. Predictors of pelvic hemorrhage control intervention and mortality were analyzed by univariate and multivariate regression analyses.
A total of 163 patients presenting in shock were enrolled from 11 Level I trauma centers. The most common pelvic fracture pattern was lateral compression I, followed by lateral compression I, and vertical shear. Of the 12 patients with an anterior-posterior compression III fracture, 10 (83%) required a pelvic hemorrhage control intervention. Factors associated with the need for pelvic fracture hemorrhage control intervention on univariate analysis included vertical shear pelvic fracture pattern, increasing age, and transfusion of blood products. Anterior-posterior compression III fracture patterns and open pelvic fracture predicted the need for pelvic hemorrhage control intervention on multivariate analysis. Overall in-hospital mortality for patients admitted in shock with pelvic fracture was 30% and did not differ based on pelvic fracture pattern on multivariate analysis.
Blunt trauma patients admitted in shock with anterior-posterior compression III fracture patterns or patients with open pelvic fracture are at greatest risk of bleeding requiring pelvic hemorrhage control intervention.
Prognostic/epidemiologic study, level III.
OBJECTIVES:To determine whether resuscitation of severely injured patients with modified whole blood (mWB) resulted in fewer overall transfusions compared with component (COMP) therapy.
...BACKGROUND:For decades, whole blood (WB) was the primary product for resuscitating patients in hemorrhagic shock. After dramatic advances in blood banking in the 1970s, blood donor centers began supplying hospitals with individual components red blood cell (RBC), plasma, platelets and removed WB as an available product. However, no studies of efficacy or hemostatic potential in trauma patients were performed before doing so.
METHODS:Single-center, randomized trial of severely injured patients predicted to large transfusion volume. Pregnant patients, prisoners, those younger than 18 years or with more than 20% total body surface area burns (TBSA) burns were excluded. Patients were randomized to mWB (1 U mWB) or COMP therapy (1 U RBC+ 1 U plasma) immediately on arrival. Each group also received 1 U platelets (apheresis or prepooled random donor) for every 6 U of mWB or 6 U of RBC + 6 U plasma. The study was performed under the Exception From Informed Consent (Food and Drug Administration 21 code of federal regulations CFR 50.24). Primary outcome was 24-hour transfusion volumes.
RESULTS:A total of 107 patients were randomized (55 mWB, 52 COMP therapy) over 14 months. There were no differences in demographics, arrival vitals or laboratory values, injury severity, or mechanism. Transfusions were similar between groups (intent-to-treat analysis). However, when excluding patients with severe brain injury (sensitivity analysis), WB group received less 24-hour RBC (median 3 vs 6, P = 0.02), plasma (4 vs 6, P = 0.02), platelets (0 vs 3, P = 0.09), and total products (11 vs 16, P = 0.02).
CONCLUSIONS:Compared with COMP therapy, WB did not reduce transfusion volumes in severely injured patients predicted to receive massive transfusion. However, in the sensitivity analysis (patients without severe brain injuries), use of mWB significantly reduced transfusion volumes, achieving the prespecified endpoint of this initial pilot study.
To describe the current use of the ER-REBOA catheter and associated outcomes and complications.
Noncompressible truncal hemorrhage is the leading cause of potentially preventable death in trauma ...patients. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a novel strategy to obtain earlier temporary hemorrhage control, supporting cardiac, and cerebral perfusion before definitive hemostasis.
Prospective, observational study conducted at 6 Level 1 Trauma Centers over 12-months. Inclusion criteria were age >15 years of age with evidence of truncal hemorrhage below the diaphragm and decision for emergent hemorrhage control intervention within 60 minutes of arrival. REBOA details, demographics, mechanism of injury, complications, and outcomes were collected.
A total of 8166 patients were screened for enrollment. In 75, REBOA was utilized for temporary hemorrhage control. Blunt injury occurred in 80% with a median injury severity score (ISS) 34 (21, 43). Forty-seven REBOAs were placed in Zone 1 and 28 in Zone 3. REBOA inflation increased systolic blood pressure from 67 (40, 83) mm Hg to 108 (90, 128) mm Hg 5 minutes after inflation (P = 0.02). Cardiopulmonary resuscitation was ongoing during REBOA insertion in 17 patients (26.6%) and 10 patients (58.8%) had return of spontaneous circulation after REBOA inflation. The procedural complication rate was 6.6%. Overall mortality was 52%.
REBOA can be used in blunt and penetrating trauma patients, including those in arrest. Balloon inflation uniformly improved hemodynamics and was associated with a 59% rate of return of spontaneous circulation for patients in arrest. Use of the ER-REBOA catheter is technically safe with a low procedural complication rate.
Resuscitative endovascular balloon occlusion of the aorta (REBOA) is increasingly used in some trauma settings. Arterial access-related limb ischemic complications (ARLICs) resulting from the femoral ...arterial access required for REBOA are largely under reported. We sought to describe the incidence of these complications and the clinical, technical, and device factors associated with their development.
This was a retrospective cohort study of records of adult trauma patients from the American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acute care surgery registry between October 2013 and September 2020 who had REBOA and survived at least 48 hours. The primary outcome was ARLIC, defined as clinically relevant extremity ischemia or distal embolization. Relevant factors associated with ARLIC were also analyzed.
Of 418 identified patients, 36 (8.6%) sustained at least one ARLIC; 22 with extremity ischemia, 25 with distal embolism, 11 with both. Patient demographics and injury characteristics were similar between ARLIC and no ARLIC groups. Access-related limb ischemic complication was associated with larger profile devices (p = 0.009), cutdown access technique (p = 0.02), and the presence of a pelvic external fixator/binder (p = 0.01). Patients with ARLIC had higher base deficit (p = 0.03) and lactate (p = 0.006). One hundred fifty-six patients received tranexamic acid (TXA), with 22 (14%) ARLICs. The rate of TXA use among ARLIC patients was 61% (vs. 35% TXA for non-ARLIC patients, p = 0.002). Access-related limb ischemic complication did not result in additional in-hospital mortality, however, ARLIC had prolonged hospital LOS (31 vs. 24 days, p = 0.02). Five ARLIC required surgical intervention, three patch angioplasty (and two with associated bypass), and four ARLIC limbs were amputated.
Femoral artery REBOA access carries a risk of ARLIC, which is associated with unstable pelvis fractures, severe shock, and strongly with the administration of TXA. Use of lower-profile devices and close surveillance for these complications is warranted in these settings and caution should be exercised when using TXA in conjunction with REBOA.
Prognostic and Epidemiologic, Level III.
Reliable, accurate, and non-invasive hemoglobin measurements would be useful in the trauma setting. The aim of this study was to re-examine the ability of the Masimo Radical 7 in this setting after ...recent hardware and software improvements.
Level 1 Trauma patients were prospectively enrolled in the study over a 9-mo period with the goal of obtaining 3 paired data points from 150 patients admitted to the ICU or IMU. Hospital laboratory hemoglobin values were compared with cyanomethemoglobin (HiCN) and Masimo device hemoglobin (SpHb) values using comparison plots and Bland-Altman analysis.
A total of 380 patients were enrolled in the study with 150 of those being admitted to the ICU or IMU. Comparison of hospital lab hemoglobin and HiCN (n = 494) found a correlation of R2 = 0.92. Comparison of hospital lab hemoglobin and Masimo device hemoglobin (n = 218) found a correlation of R2 = 0.27. Bland-Altman analysis of the 218 of the comparable hospital hemoglobin and Masimo device hemoglobin values had a bias of 0.505 g/dL with 95% of values within the limits of agreement of 4.06 g/dL to -3.60 g/dL.
The Masimo Radical 7 device has the potential to provide timely, useful clinical information, but it is not currently able to serve as an initial noninvasive diagnostic tool for trauma patients. There was poor correlation between clinical Hgb and SpHb, and because of that, SpHb should not be used to evaluate hemoglobin levels in trauma patients.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
•Survival advantage in patients bleeding below the aortic bifurcation and who underwent Zone 3 REBOA as a means of AO as compared to open AO.•This is the first study to look specifically at this ...patient population and compare open AO to REBOA.•The survival advantage seen with REBOA was accomplished without increasing systemic complications and blood component utilization.
Aortic occlusion (AO) to facilitate the acute resuscitation of trauma and acute care surgery patients in shock remains a controversial topic. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is an increasingly deployed method of AO. We hypothesized that in patients with non-compressible hemorrhage below the aortic bifurcation, the use of REBOA instead of open AO may be associated with a survival benefit.
From the AAST Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry, we identified 1494 patients requiring AO from 45 Level I and 4 Level II trauma centers. Presentation, intervention, and outcome variables were analyzed to compare REBOA vs open AO in patients with non-compressible hemorrhage below the aortic bifurcation.
From December 2014 to January 2019, 217 patients with Zone 3 REBOA or Open AO who required pelvic packing, pelvic fixation or pelvic angio-embolization were identified. Of these, 109 AO patients had injuries isolated to below the aortic bifurcation (REBOA, 84; open AO, 25). Patients with intra-abdominal or thoracic sources of bleeding, above deployment Zone 3 were excluded. Overall mortality was lower in the REBOA group (35.% vs 80%, p <.001). Excluding patients who arrived with CPR in progress, the REBOA group had lower mortality (33.33% vs. 68.75%, p = 0.012). Of the survivors, systemic complications were not significantly different between groups. In the REBOA group, 16 patients had complications secondary to vascular access. Intensive care lengths of stay and ventilator days were both significantly shorter in REBOA patients who survived to discharge.
This study compared outcomes for patients with hemorrhage below the aortic bifurcation treated with REBOA to those treated with open AO. Survival was significantly higher in REBOA patients compared to open AO patients, while complications in survivors were not different. Given the higher survival in REBOA patients, we conclude that REBOA should be used for patients with hemorrhagic shock secondary to pelvic trauma instead of open AO.
Therapeutic
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Clinicians intuitively recognize that faster time to hemostasis is important in bleeding trauma patients, but these times are rarely reported.
Prospectively collected data from the Pragmatic ...Randomized Optimal Platelet and Plasma Ratios trial were analyzed. Hemostasis was predefined as no intraoperative bleeding requiring intervention in the surgical field or resolution of contrast blush on interventional radiology (IR). Patients who underwent an emergent (within 90 minutes) operating room (OR) or IR procedure were included. Mixed-effects Poisson regression with robust error variance (controlling for age, Injury Severity Score, treatment arm, injury mechanism, base excess on admission missing values estimated by multiple imputation, and time to OR/IR as fixed effects and study site as a random effect) with modified Bonferroni corrections tested the hypothesis that decreased time to hemostasis was associated with decreased mortality and decreased incidence of acute kidney injury (AKI), acute respiratory distress syndrome (ARDS), multiple-organ failure (MOF), sepsis, and venous thromboembolism.
Of 680 enrolled patients, 468 (69%) underwent an emergent procedure. Patients with decreased time to hemostasis were less severely injured, had less deranged base excess on admission, and lower incidence of blunt trauma (all p < 0.05). In 408 (87%) patients in whom hemostasis was achieved, every 15-minute decrease in time to hemostasis was associated with decreased 30-day mortality (RR, 0.97; 95% confidence interval CI, 0.94-0.99), AKI (RR, 0.97; 95% CI, 0.96-0.98), ARDS (RR, 0.98; 95% CI, 0.97-0.99), MOF (RR, 0.94; 95% CI, 0.91-0.97), and sepsis (RR, 0.98; 95% CI, 0.96-0.99), but not venous thromboembolism (RR, 0.99; 95% CI, 0.96-1.03).
Earlier time to hemostasis was independently associated with decreased incidence of 30-day mortality, AKI, ARDS, MOF, and sepsis in bleeding trauma patients. Time to hemostasis should be considered as an endpoint in trauma studies and as a potential quality indicator.
Therapeutic/care management, level III.
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