Comparison of exsanguination and hemostasis devices for Limb surgery: a multicenter randomized controlled study.

BACKGROUND: Excessive intraoperative bleeding remains a challenge in limb surgeries. The exsanguination tourniquet ring has emerged as a potential solution for effective exsanguination and hemostasis. This study aims to evaluate its efficacy and safety compared to the conventional exsanguination and hemostasis approach (pneumatic tourniquet combined with Esmarch bandage). METHODS: This randomized controlled trial evaluates the exsanguination tourniquet ring's effectiveness and safety versus the conventional approach in 220 participants undergoing various limb surgeries. Allocation included experimental and control groups, assesses through efficacy (including intraoperative and total blood loss, hemoglobin levels, and exsanguination and hemostasis effectiveness) and safety (adverse event occurrence) indicators. RESULTS: The experimental group (n = 110) utilizes the exsanguination tourniquet ring, while the control group (n = 110) employs the conventional approach. As for intraoperative blood loss, the experimental group is non-inferior to the control group (p-value < 0.001). While no significant difference is found in total blood loss (for the full analysis set, p-value = 0.442; for the per protocol set, p-value = 0.976) and differences in postoperative and preoperative hemoglobin levels (for the full analysis set, p-value = 0.502; for the per protocol set, p-value = 0.928). Regarding exsanguination and hemostasis effectiveness, the full analysis set reveals significantly superior ratings in the experimental group compared to the control group (p-value = 0.002 < 0.05), while the per protocol set analysis indicates no significant difference between the groups (p-value = 0.504). As for safety indicators, adverse events related to the device are minimal in two groups, with only one severe event unrelated to the device. CONCLUSIONS: The exsanguination tourniquet ring is an effective and safe device for intraoperative blood loss control in various limb surgeries. TRIAL REGISTRATION: Comparison of Exsanguination and Hemostasis Devices for Limb Surgery A Prospective Multicenter Randomized Controlled Study, ChiCTR2300077998, 11/27/2023.

Prehospital Partial Resuscitative Endovascular Balloon Occlusion of the Aorta for Exsanguinating Subdiaphragmatic Hemorrhage.

Importance: Hemorrhage is the most common cause of preventable death after injury. Most deaths occur early, in the prehospital phase of care. Objective: To establish whether prehospital zone 1 (supraceliac) partial resuscitative endovascular balloon occlusion of the aorta (Z1 P-REBOA) can be achieved in the resuscitation of adult trauma patients at risk of cardiac arrest and death due to exsanguination. Design, Setting, and Participants: This was a prospective observational cohort study (Idea, Development, Exploration, Assessment and Long-term follow-up [IDEAL] 2A design) with recruitment from June 2020 to March 2022 and follow-up until discharge from hospital, death, or 90 days evaluating a physician-led and physician-delivered, urban prehospital trauma service in the Greater London area. Trauma patients aged 16 years and older with suspected exsanguinating subdiaphragmatic hemorrhage, recent or imminent hypovolemic traumatic cardiac arrest (TCA) were included. Those with unsurvivable injuries or who were pregnant were excluded. Of 2960 individuals attended by the service during the study period, 16 were included in the study. Exposures: ZI REBOA or P-REBOA. Main Outcomes and Measures: The main outcome was the proportion of patients in whom Z1 REBOA and Z1 P-REBOA were achieved. Clinical end points included systolic blood pressure (SBP) response to Z1 REBOA, mortality rate (1 hour, 3 hours, 24 hours, or 30 days postinjury), and survival to hospital discharge. Results: Femoral arterial access for Z1 REBOA was attempted in 16 patients (median [range] age, 30 [17-76] years; 14 [81%] male; median [IQR] Injury Severity Score, 50 [39-57]). In 2 patients with successful arterial access, REBOA was not attempted due to improvement in clinical condition. In the other 14 patients (8 [57%] of whom were in traumatic cardiac arrest [TCA]), 11 successfully underwent cannulation and had aortic balloons inflated in Z1. The 3 individuals in whom cannulation was unsuccessful were in TCA (failure rate = 3/14 [21%]). Median (IQR) pre-REBOA SBP in the 11 individuals for whom cannulation was successful (5 [46%] in TCA) was 47 (33-52) mm Hg. Z1 REBOA plus P-REBOA was associated with a significant improvement in BP (median [IQR] SBP at emergency department arrival, 101 [77-107] mm Hg; 0 of 10 patients were in TCA at arrival). The median group-level improvement in SBP from the pre-REBOA value was 52 (95% CI, 42-77) mm Hg (P < .004). P-REBOA was feasible in 8 individuals (8/11 [73%]) and occurred spontaneously in 4 of these. The 1- and 3-hour postinjury mortality rate was 9% (1/11), 24-hour mortality was 27% (3/11), and 30-day mortality was 82% (9/11). Survival to hospital discharge was 18% (2/11). Both survivors underwent early Z1 P-REBOA. Conclusions and Relevance: In this study, prehospital Z1 P-REBOA is feasible and may enable early survival, but with a significant incidence of late death. Trial Registration: ClinicalTrials.gov Identifier: NCT04145271.

Development of a two-hit lethal liver injury model in swine.

PURPOSE: Noncompressible truncal hemorrhage remains a leading cause of preventable death in the prehospital setting. Standardized and reproducible large animal models are essential to test new therapeutic strategies. However, existing injury models vary significantly in consistency and clinical accuracy. This study aims to develop a lethal porcine model to test hemostatic agents targeting noncompressible abdominal hemorrhages. METHODS: We developed a two-hit injury model in Yorkshire swine, consisting of a grade IV liver injury combined with hemodilution. The hemodilution was induced by controlled exsanguination of 30% of the total blood volume and a 3:1 resuscitation with crystalloids. Subsequently, a grade IV liver injury was performed by sharp transection of both median lobes of the liver, resulting in major bleeding and severe hypotension. The abdominal incision was closed within 60 s from the injury. The endpoints included mortality, survival time, serum lab values, and blood loss within the abdomen. RESULTS: This model was lethal in all animals (5/5), with a mean survival time of 24.4 ± 3.8 min. The standardized liver resection was uniform at 14.4 ± 2.1% of the total liver weight. Following the injury, the MAP dropped by 27 ± 8mmHg within the first 10 min. The use of a mixed injury model (i.e., open injury, closed hemorrhage) was instrumental in creating a standardized injury while allowing for a clinically significant hemorrhage. CONCLUSION: This novel highly lethal, consistent, and clinically relevant translational model can be used to test and develop life-saving interventions for massive noncompressible abdominal hemorrhage.

Randomised controlled trial of tourniquet associated pain generated in lower limb after exsanguination by Esmarch bandage versus limb elevation.

BACKGROUND: Tourniquets are common adjuncts in the operating theatre but can be associated with post-operative pain. This study was designed to compare what effect pre-tourniquet Esmarch bandage exsanguination has on pain, compared to pre-tourniquet exsanguination by elevation alone. METHODS: 52 volunteers (104 lower limbs) were included in this study with each volunteer acting as their own matched control. The primary outcome was patient reported pain, measured in both legs simultaneously using area under curve. Secondary outcomes were pain score during inflation and deflation, cumulative pain score, duration of recovery and blood pressure during testing. RESULTS: Pain after Esmarch was superior to elevation as measured by area under pain curve (68.9 SD 26.1 vs 77.2 SD 27.3, p = 0.0010), independent of leg dominance. Cumulative pain scores demonstrated the same superiority after inflation (50.7 SD 17.1 vs 52.9 SD 17.0, p = 0.026) but not after deflation (p = 0.59). Blood pressure was not significantly different. Time to full recovery of the lower limb was the same for both groups-7.6 min (SD 2.1 min, p = 0.80). CONCLUSION: Previous studies describe a positive effect on pain when Esmarch bandage was used prior to tourniquet inflation for upper limb. Our findings suggest the same benefit from Esmarch when it was used on lower limbs-particularly during inflation of tourniquet. In addition to pain profiles, surgeon preference and patient factors need to be considered when deciding between elevation and Esmarch bandage.

Comparing outcomes in patients with exsanguinating injuries: an Eastern Association for the Surgery of Trauma (EAST), multicenter, international trial evaluating prioritization of circulation over intubation (CAB over ABC).

INTRODUCTION: Hemorrhage is a major cause of preventable trauma deaths, and the ABC approach is widely used during the primary survey. We hypothesize that prioritizing circulation over intubation (CAB) can improve outcomes in patients with exsanguinating injuries. METHODS: A prospective observational study involving international trauma centers was conducted. Patients with systolic blood pressure below 90 who were intubated within 30 min of arrival were included. Prioritizing circulation (CAB) was defined as delaying intubation until blood products were started, and/or bleeding control was performed before securing the airway. Demographics, clinical data, and outcomes were recorded. RESULTS: The study included 278 eligible patients, with 61.5% falling within the "CAB" cohort and 38.5% in the "ABC" cohort. Demographic and disease characteristics, including age, sex, ISS, use of blood products, and other relevant factors, exhibited comparable distributions between the two cohorts. The CAB group had a higher proportion of penetrating injuries and more patients receiving intubation in the operating room. Notably, patients in the CAB group demonstrated higher GCS scores, lower SBP values before intubation but higher after intubation, and a significantly lower incidence of cardiac arrest and post-intubation hypotension. Key outcomes revealed significantly lower 24-hour mortality in the CAB group (11.1% vs. 69.2%), a lower rate of renal failure, and a higher rate of ARDS. Multivariable logistic regression models showed a 91% reduction in the odds of mortality within 24 h and an 89% reduction at 30 days for the CAB cohort compared to the ABC cohort. These findings suggest that prioritizing circulation before intubation is associated with improved outcomes in patients with exsanguinating injuries. CONCLUSION: Post-intubation hypotension is observed to be correlated with worse outcomes. The consideration of prioritizing circulation over intubation in patients with exsanguinating injuries, allowing for resuscitation, or bleeding control, appears to be associated with potential improvements in survival. Emphasizing the importance of circulation and resuscitation is crucial, and this approach might offer benefits for various bleeding-related conditions.

Between the hammer and the anvil: An unusual power hammer fatality.

Power hammers are mechanised forging devices that constitute a pivotal part of steel manufacturing. Power hammer-associated injuries are a rare occurrence. We report a noteworthy case of a 52-year-old man who sustained a high-energy penetrating injury while working with a power (counterblow) hammer. The man used a sizable disc-shaped metallic object to dislodge the forging wedged in the machine by applying the force of the striking ram on it. On impact, the object ejected and struck the man in the right lateral portion of the chest. The autopsy disclosed extensive damage to the thoracic and abdominal organs. The cause of death was opined to be exsanguination due to penetrating trauma of the heart and transection of the descending aorta. The investigation confirmed a breach of safety regulations. To the best of our knowledge, this is the first power (counterblow) hammer-related fatality in medico-legal literature.

Effective approaches to address noncompressible torso hemorrhage.

PURPOSE OF REVIEW: Noncompressible torso hemorrhage (NCTH) is now considered as the major cause of preventable death after both severe military and civilian trauma. Around 20% of all trauma patients still die from uncontrolled exsanguination along with rapidly evolving hemostatic failure. This review highlights the most recent advances in the field and provides an outline for future research directions. RECENT FINDINGS: The updated definition of NCTH includes a combination of high-grade anatomical torso injury, hemodynamic instability, urgent need for hemorrhage control and aggressive hemostatic resuscitation. Therapeutic concepts consider the following three aspects: control the bleeding source (close the tap), resuscitate to maintain organ perfusion and restore hemostasis (fill the tank), and increase the body's resistance against ischemia (upgrade the armor). SUMMARY: The concepts for the early management of NCTH have substantially evolved over the last decade. The development of new devices and techniques combined with early intervention of hemostatic failure have contributed to more successful resuscitations. Future research needs to refine and validate their potential clinical application.

O blood type is not associated with worse coagulopathy or outcome in exsanguinating trauma.

BACKGROUND: Despite improving understanding of trauma-induced coagulopathy (TIC), mortality and morbidity due to exsanguinating trauma remain high. Increased complications due to hemorrhage have been reported in blood group O, possibly due to reduced levels of von Willebrand factor (vWF). METHODS: An urban level 1 adult trauma center registry was retrospectively queried. Patients receiving ≥6 units of pRBC within 4 â€‹h of presentation were included. Patient demographics, admission labs and outcomes were obtained. Univariate and multiple logistic regression analyses were performed. RESULTS: 562 patients were identified. There were no significant differences in demographics, admission labs, or outcome between different ABO groups. After adjustment, Type A patients were more likely to be hypocoagulable compared to Type O patients (p â€‹= â€‹0.014). No mortality differences were seen between ABO types in multiple regression analysis. CONCLUSIONS: No outcome or mortality differences were seen between ABO types, therefore factors other than vWF expression should be considered to explain coagulopathy in trauma patients.

Management of Pelvic Trauma.

Pelvic fractures are common after blunt trauma with patients' presentation ranging from stable with insignificant fractures to life-threatening exsanguination from unstable fractures. Often, hemorrhagic shock from a pelvic fracture may go unrecognized and high clinical suspicion for a pelvic source lies with the clinician. A multidisciplinary coordinated effort is required for management of these complex patients. In the exsanguinating patient, hemorrhage control remains the top priority and may be achieved with external stabilization, resuscitative endovascular balloon occlusion of the aorta, preperitoneal pelvic packing, angiographic intervention, or a combination of therapies. These modalities have been shown to reduce mortality in this challenging population.

Impact of Prehospital Exsanguinating Airway-Breathing-Circulation Resuscitation Sequence on Patients with Severe Hemorrhage.

BACKGROUND: At the 2023 ATLS symposium, the priority of circulation was emphasized through the "x-airway-breathing-circulation (ABC)" sequence, where "x" stands for exsanguinating hemorrhage control. With growing evidence from military and civilian studies supporting an x-ABC approach to trauma care, a prehospital advanced resuscitative care (ARC) bundle emphasizing early transfusion was developed in our emergency medical services (EMS) system. We hypothesized that prioritization of prehospital x-ABC through ARC would reduce in-hospital mortality. STUDY DESIGN: This was a single-year prospective analysis of patients with severe hemorrhage. These patients were combined with our institution's historic controls before prehospital blood implementation. Included were patients with systolic blood pressure (SBP) less than 90 mmHg. Excluded were patients with penetrating head trauma or prehospital cardiac arrest. Two-to-one propensity matching for x-ABC to ABC groups was conducted, and the primary outcome, in-hospital mortality, was compared between groups. RESULTS: A total of 93 patients (x-ABC = 62, ABC = 31) met the inclusion criteria. There was no difference in patient age, sex, initial SBP, initial Glasgow Coma Score, and initial shock index between groups. When compared with the ABC group, x-ABC patients had significant improvement in vitals at emergency department admission. Overall mortality was lower in the x-ABC group (13% vs 47%, p < 0.001). Multivariable regression revealed that prehospital circulation-first prioritization was independently associated with decreased in-hospital mortality (odds ratio 0.15, 95% CI 0.04 to 0.54, p = 0.004). CONCLUSIONS: This is the first analysis to demonstrate a prehospital survival benefit of x-ABC in this subset of patient with severe injury and hemorrhagic shock. Standardization of prehospital x-ABC management in this patient population warrants special consideration.

Consensus on resuscitative endovascular balloon occlusion of the aorta in civilian (prehospital) trauma care: A Delphi study.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) could prevent lethal exsanguination and support cardiopulmonary resuscitation. In prehospital trauma and medical emergency settings, a small population with high mortality rates could potentially benefit from early REBOA deployment. However, its use in these situations remains highly disputed. Since publication of the first Delphi study on REBOA, in which consensus was not reached on all addressed topics, new literature has emerged. The aim of this study was to establish consensus on the use and implementation of REBOA in civilian prehospital settings for noncompressible truncal hemorrhage and out-of-hospital cardiac arrest as well as for various in-hospital settings. METHODS: A Delphi study consisting of three rounds of questionnaires was conducted based on a review of recent literature. REBOA experts with different medical specialties, backgrounds, and work environments were invited for the international panel. Consensus was reached when a minimum of 75% of panelists responded to a question and at least 75% (positive) or less than 25% (negative) of these respondents agreed on the questioned subject. RESULTS: Panel members reached consensus on potential (contra)indications, physiological thresholds for patient selection, the use of ultrasound and practical, and technical aspects for early femoral artery access and prehospital REBOA. CONCLUSION: The international expert panel agreed that REBOA can be used in civilian prehospital settings for temporary control of noncompressible truncal hemorrhage, provided that personnel are properly trained and protocols are established. For prehospital REBOA and early femoral artery access, consensus was reached on (contra)indications, physiological thresholds and practical aspects. The panel recommends the initiation of a randomized clinical trial investigating the use of prehospital REBOA for noncompressible truncal hemorrhage. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level V.

Evaluation of hemostatic devices in a randomized porcine model of junctional hemorrhage and 72-hour prolonged field care.

BACKGROUND: Hemorrhage control in prolonged field care (PFC) presents unique challenges that drive the need for enhanced point of injury treatment capabilities to maintain patient stability beyond the Golden Hour. To address this, two hemostatic agents, Combat Gauze (CG) and XSTAT, were evaluated in a porcine model of uncontrolled junctional hemorrhage for speed of deployment and hemostatic efficacy over 72 hours. METHODS: The left subclavian artery and subscapular vein were isolated in anesthetized male Yorkshire swine (70-85 kg) and injured via 50% transection, followed by 30 seconds of hemorrhage. Combat Gauze (n = 6) or XSTAT (n = 6) was administered until bleeding stopped and remained within subjects for observation over 72 hours. Physiologic monitoring, hemostatic efficacy, and hematological parameters were measured throughout the protocol. Gross necropsy and histology were performed following humane euthanasia. RESULTS: Both CG and XSTAT maintained hemostasis throughout the full duration of the protocol. There were no significant differences between groups in hemorrhage volume (CG: 1021.0 ± 183.7 mL vs. XSTAT: 968.2 ± 243.3 mL), total blood loss (CG: 20.8 ± 2.7% vs. XSTAT: 20.1 ± 5.1%), or devices used (CG: 3.8 ± 1.2 vs. XSTAT: 5.3 ± 1.4). XSTAT absorbed significantly more blood than CG (CG: 199.5 ± 50.3 mL vs. XSTAT: 327.6 ± 71.4 mL) and was significantly faster to administer (CG: 3.4 ± 1.6 minutes vs. XSTAT: 1.4 ± 0.5 minutes). There were no significant changes in activated clot time, prothrombin time, or international normalized ratio between groups or compared with baseline throughout the 72-hour protocol. Histopathology revealed no evidence of microthromboemboli or disseminated coagulopathies across evaluated tissues in either group. CONCLUSION: Combat Gauze and XSTAT demonstrated equivalent hemostatic ability through 72 hours, with no overt evidence of coagulopathies from prolonged indwelling. In addition, XSTAT offered significantly faster administration and the ability to absorb more blood. Taken together, XSTAT offers logistical and efficiency advantages over CG for immediate control of junctional noncompressible hemorrhage, particularly in a tactical environment. In addition, extension of indicated timelines to 72 hours allows translation to PFC.

Manner of death determination in a case of gastric mucosal tears.

Gastric tears are rarely described in the forensic pathological literature, although they can lead to a fatal acute exsanguination. Such lesions can arise from several conditions leading to an increased intragastric pressure, such as Mallory Weiss syndrome, cardiopulmonary resuscitation, acute barotrauma and operative procedures, showing peculiar morphological features. We present a case of a 32-year-old drug addicted white woman found dead in a pool of blood in the house of her drug dealer, after taking a dose of intravenous heroin. At autopsy, abundant bloody gastric content and multiple and long gastric tears, extending from the cardias and fundus regions to the gastric corpus were observed; one of them involved the subserous region, resulting in a gastric wall rupture. The victim had no history of recent vomiting and of gastro-intestinal pathologies. Drugs and ethanol levels detected in the specimens of the victim were not consistent with lethal concentrations, thus the death was attributed to acute exsanguination. After reviewing the literature, it turned out that morphological aspects of the gastric tears, such as number, size and topographical distribution, observed at autopsy were atypical compared to those of typical gastric lacerations.