A case study of 10 patients administered HBOC-201 in high doses over a prolonged period: outcomes during severe anemia when transfusion is not an option.

BACKGROUND: Hemoglobin-Based Oxygen Carriers (HBOCs) can act as an "oxygen bridge" in acute severe anemia when transfusion is indicated, but not possible. We present data on 10 Expanded Access (EA) patients treated with high cumulative doses of Hemopure (HBOC-201), to assess the ability of HBOC-201 to safely treat life threatening anemia in situations where high volumes of product were administered over an extended period of time. STUDY DESIGN AND METHODS: Inclusion in this study required that the patient receive at least 10 units of HBOC-201 between 2014 and 2017 under the FDA-sanctioned EA program. Depending on a patient's geographical location, treatment with HBOC-201 was obtained through either a single patient emergency Investigational New Drug (IND) application, or an intermediate size population IND. Of the 41 patients who were treated during this period, 10 patients received 10 or more units of the product. Data were obtained from medical records. RESULTS: Treatments with HBOC-201 started within 24 hours of signing consent and were administered at an average rate of 1.99 (SD 0.17) units per day over a mean of 8.2 days (SD 2.9), during which patients received on average 16.2 units (SD 5.7 units) of HBOC-201. The median pre-treatment nadir corpuscular hemoglobin (Hb) concentration was 3.3 (SD 0.9) g/dL and post-treatment Hemoglobin was 7.3 (SD 1.7) g/dL. Common side effects included methemoglobinemia, gastrointestinal symptoms, and hypertension. However, no product-related serious adverse events (SAEs) were noted. All patients survived. CONCLUSIONS: Administration of HBOC-201 over an extended period is a feasible and safe oxygen bridge for severely anemic patients who cannot be transfused with RBC.

Do pre-hospital trauma alert criteria predict the severity of injury and a need for an emergent surgical intervention?

OBJECTIVE: Efficient triage may have a major influence on mortality and morbidity as well as financial consequences. A continuous effort to improve this decision making process and update the trauma alert criteria is being made. However, criteria for determining the evacuation priority are not well developed. We performed a prospective study to evaluate which pre-hospital parameters identify major trauma victims with an emphasis on a need for emergent surgical procedures. METHODS: A prospective cohort included 601 patients admitted to a level one trauma centre over a three months period. The pre-hospital trauma alert criteria were recorded and set as independent variables. All major surgical procedures were graded in real time as: emergent, urgent, or not urgent. The ISS was calculated after completion of all the diagnostic workup. Patients were classified as major trauma victims if their calculated ISS was 16 or greater, and those needed an urgent intervention or intensive care. The relative risks (RR) for major trauma and a need for an emergent operation were calculated. RESULTS: 243 (40%) patients were classified as having a major trauma. 39 (6.5%) patients required an emergent operative intervention: 24 for an active bleeding, 5 for a pericardial tamponade and 10 for an imminent cerebral herniation. Paramedic judgement and a penetrating injury to the trunk were the most common causes for over triage. However, a penetrating injury to the trunk had been the only clue that the victim needed an emergent operation in five cases. 128 patients had a pre-hospital Glasgow coma score (GCS) ≤ 12. Altered mental status was the most common and a significant predictor of both major trauma (RR of 3.00 with a 95% confidence interval (CI) of 1.98-4.53) and a need for an emergent operation (RR, 95% CI: 4.43, 2.28-8.58). Also, a systolic blood pressure ≤ 90 mmHg was highly associated with an emergent operation (RR, 95% CI: 11.69, 5.85-23.36). CONCLUSION: For determining the evacuation priority, we suggest a triage system based on three major criteria: mental status, hypotension and a penetrating injury to the trunk. Overall, the set of trauma alert criteria system can be further simplified and enable better utilisation of resources.

Management of conventional mass casualty incidents: ten commandments for hospital planning.

The successful management of mass casualty incidents (MCIs) requires standardization of planning, training, and deployment of response. Recent events in the United States, most importantly the Hurricane season in 2005, demonstrated a lack of a unified response plan at local, regional, state, and federal levels. A standard Israeli protocol for hospital preparedness for conventional MCIs, produced by the Office of Emergency Preparedness of the Israeli Ministry of Health, has been reviewed, modified, adapted, and tested in both drills and actual events at a large university medical center in the United States. Lessons learned from this process are herein presented as the10 most important steps (ie, Commandments) to follow when preparing hospitals to be able to respond to conventional MCIs. The standard Israeli emergency protocols have proved to be universally adaptable, flexible, and designed to be adapted by any healthcare institution, regardless of its size and location.

What does ultrasonography miss in blunt trauma patients with a low Glasgow Coma Score (GCS)?

BACKGROUND: The role of ultrasound (US) as a screening tool for the evaluation of blunt abdominal trauma is still controversial. Determining the types of missed injuries and the accuracy of US in patients with a low GCS will improve the evaluation of these blunt trauma patients. METHODS: Prospectively collected data from the trauma registry of a Level I trauma center was reviewed. RESULTS: 7,952 patients were included in the study. US examination had an accuracy of 89%, sensitivity of 77%, specificity of 97%, positive predictive value (PPV) of 78%, and negative predictive value (NPV) of 98%. GCS correlated with ISS and base deficit levels. US examination had a significantly lower accuracy in patients with a low GCS and in women. CONCLUSION: The sensitivity and specificity of US examination is similar in those with normal and low GCS. Therefore ultrasonographic examination may be considered a good screening tool for the evaluation of patients with blunt abdominal trauma, but its accuracy is diminished in patients with a low GCS. Further imaging may be warranted in these patients.

An update on the surgeons scope and depth of practice to all hazards emergency response.

This article outlines the position of The Eastern Association of the Surgery of Trauma (EAST) in defining the role of surgeons, and specifically trauma/critical care surgeons, in the development of public health initiatives that are designed to react to and deal effectively with acts of terrorism. All aspects of the surgeon's role in response to mass casualty incidents are considered, from prehospital response teams to the postevent debriefing. The role of the surgeon in response to mass casualty incidents (MCIs) is substantial in response to threats and injury from natural, unintentional, and intentional disasters. The surgeon must take an active role in pre-event community preparation in training, planning, and executing the response to MCI. The marriage of initiatives among Departments of Public Health, the Department of Homeland Security, and existing trauma systems will provide a template for successful responses to terrorist acts.

Database predictors of transfusion and mortality.

Transfusion is a cornerstone of early trauma care, but little is known regarding the consistency of transfusion practice in different regions of the world. We examined data available in the German Trauma Registry, the University of Miami Trauma Registry, and the Registry of the Shock Trauma Center in Baltimore to learn more regarding this question. We sought to identify the rate of transfusion of trauma patients during the resuscitative phase, the volume of transfusion administered, and the correlation of various levels of transfusion with clinical outcomes such as mortality, hospital length of stay, and the incidence of organ system failure. Mortality associated with transfusion was remarkably similar in all three systems, making it clear that the volume of blood received during early resuscitation is a strong predictor of outcome for patients presenting in hemorrhagic shock.

A burn mass casualty event due to boiler room explosion on a cruise ship: preparedness and outcomes.

The purpose of this study was to review our experience with a mass casualty incident resulting from a boiler room steam explosion aboard a cruise ship. Experience with major, moderate, and minor burns, steam inhalation, mass casualty response systems, and psychological sequelae will be discussed. Fifteen cruise ship employees were brought to the burn center after a boiler room explosion on a cruise ship. Eleven were triaged to the trauma resuscitation area and four to the surgical emergency room. Seven patients were intubated for respiratory distress or airway protection. Six patients had >80 per cent burns with steam inhalation, and all of these died. One of the 6 patients had 99 per cent burns with steam inhalation and died after withdrawal of support within the first several hours. All patients with major burns required escharotomy on arrival to trauma resuscitation. One patient died in the operating room, despite decompression by laparotomy for abdominal compartment syndrome and pericardiotomy via thoracotomy for cardiac tamponade. Four patients required crystalloid, 20,000 mls/m2-27,000 ml/m2 body surface area (BSA) in the first 48 hours to maintain blood pressure and urine output. Three of these four patients subsequently developed abdominal compartment syndrome and died in the first few days. The fourth patient of this group died after 26 days due to sepsis. Five patients had 13-20 per cent bums and four patients had less than 10 per cent burns. Two of the patients with 20 per cent burns developed edema of the vocal cords with mild hoarseness. They improved and recovered without intubation. The facility was prepared for the mass casualty event; having just completed a mass casualty drill several days earlier. Twenty-six beds were made available in 50 minutes for anticipated casualties. Fifteen physicians reported immediately to the trauma resuscitation area to assist in initial stabilization. The event occurred at shift change; thus, adequate support personnel were instantaneously to hand. Our mass casualty preparation proved useful in managing this event. Most of the patients who survived showed signs of post-traumatic stress syndrome, which was diagnosed and treated by the burn center psychology team. Despite our efforts at treating large burns (>80%) with steam inhalation, mortality was 100 per cent. Fluid requirements far exceeded those predicted by the Parkland (Baxter) formula. Abdominal compartment syndrome proved to be a significant complication of this fluid resuscitation. A coordinated effort by the facility and preparation for mass casualty events are needed to respond to such events.

Spine injuries are common among asymptomatic patients after gunshot wounds.

BACKGROUND: Spine injuries after gunshot wounds are thought to be rare among asymptomatic patients. The occurrence of spine injuries among asymptomatic patients with gunshot wounds was studied to determine the necessity for mandatory spine immobilization and radiographic imaging. METHODS: In this retrospective cohort study, initial physical examination, radiographic findings, and final diagnosis and treatment were reviewed. Patients were included if they were admitted to the authors' level 1 trauma center with gunshot wounds to the head, neck, or trunk during a 10-year period. Spine injuries were considered "significant" if the injury was associated with spinal cord injury or required spine-related surgical procedures or prolonged spine immobilization. Spine injuries were defined as "unsuspected" if there were no neurologic findings at admission. RESULTS: During the study period, 2,450 patients who survived more than 24 hours were admitted with gunshot wounds to the trunk, neck, or head. Of these patients, 244 (approximately 10%) had spine injuries, and 228 of them had complete records. Two thirds of the spine injuries were found to be significant, requiring surgery or prolonged immobilization, and 13% were unsuspected. CONCLUSIONS: Spine injuries without neurologic signs are not uncommon among patients with gunshot wounds. Complete radiographic spine imaging is therefore recommended to ensure that spine injuries are not missed in this population.

Secondary ultrasound examination increases the sensitivity of the FAST exam in blunt trauma.

INTRODUCTION: Approximately one third of stable patients with significant intra-abdominal injury do not have significant intraperitoneal blood evident on admission. We hypothesized that a delayed, repeat ultrasound study (Secondary Ultrasound--SUS) will reveal additional intra-abdominal injuries and hemoperitoneum. METHODS: We performed a prospective observational study of trauma patients at our Level I trauma center from April 2003 to December 2003. Patients underwent an initial ultrasound (US), followed by a SUS examination within 24 hours of admission. Patients not eligible for a SUS because of early discharge, operative intervention or death were excluded. All US and SUS exams were performed and evaluated by surgical/emergency medicine house staff or surgical attendings. RESULTS: Five hundred forty-seven patients had both an initial US and a SUS examination. The sensitivity of the initial US in this patient population was 31.1% and increased to 72.1% on SUS (p < 0.001) for intra-abdominal injury or intra-abdominal fluid. The specificity for the initial US was 99.8% and 99.8% for SUS. The negative predictive value was 92.0% for the initial US and increased to 96.6% for SUS (p = 0.002). The accuracy of the initial ultrasound was 92.1% and increased to 96.7% on the SUS (p < 0.002). No patient with a negative SUS after 4 hours developed clinically significant hemoperitoneum. CONCLUSION: A secondary ultrasound of the abdomen significantly increases the sensitivity of ultrasound to detect intra-abdominal injury.

A prospective evaluation of ultrasonography for the diagnosis of penetrating torso injury.

BACKGROUND: Ultrasound (US) is commonly used for the diagnosis of hemoperitoneum after blunt abdominal trauma, but the value of US as an aid for identification of operative lesions after penetrating trauma is not well documented. The purpose of this investigation was to determine the accuracy of US for the evaluation of penetrating torso trauma and to assess the impact of this information on patient management. METHODS: We conducted a prospective cohort observational study of consecutive penetrating torso patients at a Level I trauma center. RESULTS: During the 6-month trial period, 177 victims of penetrating torso trauma were assessed by our trauma teams. Ninety-two patients had stab wounds, 84 patients had gunshot wounds, and 1 patient had a puncture wound. All 28 patients with positive US examination had an exploratory laparotomy or thoracotomy (one patient had more than one procedure), resulting in 26 therapeutic operations. There were 149 negative US examinations, but in this group, 36 patients underwent laparotomy or thoracotomy, and 28 had therapeutic operations. The overall accuracy of the US examination was therefore 85%, the sensitivity was 48%, and the specificity was 98%. There were only three patients who had their initial management altered by a positive US examination. CONCLUSION: The US examination lacks sensitivity to be used alone in determining operative intervention after gunshot or stab wounds. Rarely does US information contribute to the management of patients with penetrating abdominal injuries.

Diagnostic peritoneal lavage through an abdominal stab wound.

Diagnostic peritoneal lavage (DPL) is one of the most useful tools in the diagnosis of intraperitoneal injuries secondary to stab wounds. The lavage catheter is inserted into the peritoneal cavity through a surgical incision or a blind puncture. Complications related to the catheter insertion were previously reported in both techniques. We describe 2 cases in which the lavage catheter was inserted through the stab wound itself after local wound exploration clearly demonstrated violation of the peritoneum. We suggest that in anterior abdominal stab wounds, the DPL can be safely and effectively performed through the stab wound if penetration to the peritoneum is diagnosed.

Early coagulopathy predicts mortality in trauma.

BACKGROUND: Coagulopathy and hemorrhage are known contributors to trauma mortality; however, the actual relationship of prothrombin time (PT) and partial thromboplastin time (PTT) to mortality is unknown. Our objective was to measure the predictive value of the initial coagulopathy profile for trauma-related mortality. METHODS: We reviewed prospectively collected data on trauma patients presenting to a Level I trauma center. A logistic regression analysis was performed of PT, PTT, platelet count, and confounders to determine whether coagulopathy is a predictor of all-cause mortality. RESULTS: From a trauma registry cohort of 20103 patients, 14397 had complete disposition data for initial analysis and 7638 had complete data for all variables in the final analysis. The total cohort was 76.2% male, the mean age was 38 years (range, 1-108 years), and the median Injury Severity Score was 9. There were 1276 deaths (all-cause mortality, 8.9%). The prevalence of coagulopathy early in the postinjury period was substantial, with 28% of patients having an abnormal PT (2994 of 10790) and 8% of patients having an abnormal PTT (826 of 10453) on arrival at the trauma bay. In patients with disposition data and a normal PT, 489 of 7796 died, as compared with 579 of 2994 with an abnormal PT (6.3% vs. 19.3%; chi2 = 414.1, p < 0.001). Univariate analysis generated an odds ratio of 3.6 (95% confidence interval [CI], 3.15-4.08; p < 0.0001) for death with abnormal PT and 7.81 (95% CI, 6.65-9.17; p < 0.001) for deaths with an abnormal PTT. The PT and PTT remained independent predictors of mortality in a multiple regression model, whereas platelet count did not. The model also included the independent risk factors age, Injury Severity Score, scene and trauma-bay blood pressure, hematocrit, base deficit, and head injury. The model generated an adjusted odds ratio of 1.35 for PT (95% CI, 1.11-1.68; p < 0.001) and 4.26 for PTT (95% CI, 3.23-5.63; p < 0.001). CONCLUSION: The incidence of coagulation abnormalities, early after trauma, is high and they are independent predictors of mortality even in the presence of other risk factors. An initial abnormal PT increases the adjusted odds of dying by 35% and an initial abnormal PTT increases the adjusted odds of dying by 326%.

Tourniquets for hemorrhage control on the battlefield: a 4-year accumulated experience.

BACKGROUND: Tourniquet application is a known means for bleeding prevention in the military prehospital setting. METHODS: This study was a 4-year retrospective analysis of silicone and improvised tourniquet applications by Israeli Defense Force soldiers. RESULTS: Of 550 soldiers who were treated in the prehospital setting, tourniquets were applied to 91 (16%) patients and in less than 15 minutes in 88% of the cases with almost no complications. Penetrating trauma was the main mechanism of injury. The indication was situational and nonmedical in 58 (53%) of the cases. The patients' ischemic time was 83 +/- 52 minutes (range, 1-305 minutes). A total of 78% of applications were effective, with higher success rates for medical staff compared with fellow soldiers and for upper limbs (94%) compared with lower limbs (71%, p < 0.01). CONCLUSION: Tourniquet application is an effective and easily applied (by medical and nonmedical personnel) method for prevention of exsanguination in the military prehospital setting.

Early injection of high-dose recombinant factor VIIa decreases blood loss and prolongs time from injury to death in experimental liver injury.

BACKGROUND: Recombinant factor VIIa (rFVIIa) is used for treatment of bleeding episodes in hemophilia patients who develop inhibitors to factors VIII and IX. We tested the hypothesis that administration of rFVIIa early after injury would decrease bleeding and prolong the time from injury to death after experimental hepatic trauma. METHODS: Anesthetized swine were cannulated for blood sampling and hemodynamic monitoring. Avulsion of the left median lobe of the liver induced uncontrolled hemorrhage. After a 10% reduction in mean arterial pressure, animals (n = 8 per group) were blindly randomized to receive intravenous rFVIIa 180 microg/kg, rFVIIa 720 microg/kg, or placebo. Pathologic examination of brain, lung, kidney, heart, and small bowel was performed to assess intravascular thrombosis. RESULTS Mortality during the first hour was 50% (four of eight) in controls versus 0% with rFVIIa 720 microg/kg (p = 0.02, chi2). Blood loss was decreased in the rFVIIa 720 microg/kg group versus the placebo group (13.2 +/- 5.5 mL/kg vs. 21.9 +/- 7.7 mL/kg;p = 0.0223). Time from injury to death was significantly prolonged in the rFVIIa 720 microg/kg group compared with placebo (116 minutes vs. 8.5 +/- 3.5 minutes; p= 0.02). No macro- or microthrombi in vital organs were identified on pathologic examination. CONCLUSION: Intravenous administration of high-dose rFVIIa early after induction of hemorrhage decreased bleeding and prolonged survival. No evidence of thrombosis in vital organs was observed.

Updates in the management of severe coagulopathy in trauma patients.

Coagulopathy is the major cause of bleeding-related mortality in patients who survive the operating room. Its association with hypothermia and metabolic acidosis is common and constitutes a vicious cycle. Usually, post-traumatic coagulopathy is an early event and may be present during surgery. The pathogenesis of severe post-traumatic coagulopathy is complex and multifactorial. Virtually every aspect of the normal coagulation cascade is affected in the cold, acidotic, exsanguinating trauma patient. In the last decade many surgeons have emphasized the role of prevention or early treatment of this vicious cycle. Damage control surgery with planned re-operations has demonstrated superiority over the traditional approach in cases where the patients' condition is deteriorating. Early control of surgical bleeding and significant contamination, together with vigorous correction of hypothermia and continuous resuscitation, has improved the survival of these patients. Recently, a new adjunct to the treatment of coagulopathy in trauma patients has been reported and is undergoing controlled animal trials. Recombinant activated factor VII (rFVIIa) was originally developed as a pro-hemostatic agent for the treatment of bleeding episodes in hemophilia patients. rFVIIa has been successfully used in moribund trauma patients in whom standard procedures had failed to correct bleeding. Preliminary preclinical and clinical studies are under way.

Early use of recombinant factor VIIa improves mean arterial pressure and may potentially decrease mortality in experimental hemorrhagic shock: a pilot study.

BACKGROUND: Recombinant factor VIIa (rFVIIa) is used for treatment of bleeding episodes in hemophilia patients who develop inhibitors to factors VIII and IX. We tested the hypothesis that administration of rFVIIa early after injury would decrease bleeding and improve survival after experimental hepatic trauma. METHODS: Anesthetized swine were cannulated for blood sampling and hemodynamic monitoring. Avulsion of left median lobe of the liver induced uncontrolled hemorrhage. After a 10% reduction of mean arterial pressure, animals were blindly randomized to receive intravenous rFVIIa (180 microg/kg) (n = 6) or placebo (n = 7). RESULTS: Mortality was 43% (three of seven) in controls versus 0% with rFVIIa (p = 0.08, chi2). Significantly shorter prothrombin time and higher mean arterial pressures were observed in the rFVIIa group. CONCLUSION: Intravenous administration of rFVIIa early after induction of hemorrhage shortens prothrombin time and improves mean arterial pressure. A trend toward improved survival was observed.

The incision of choice for pregnant women with appendicitis is through McBurney's point.

BACKGROUND: There is uncertainty over the optimal incision for gravid patients with appendicitis. METHODS: Data were collected retrospectively from January 1, 1995, through December 31, 2000, on 374 women of childbearing age who underwent appendectomies. Of these, 23 gravid patients were evaluated. RESULTS: Eighteen incisions were made over McBurney's point and five were created superior to McBurney's point. Patients in the third trimester of pregnancy all received incisions over McBurney's point. The appendix was located without difficulty in all 4 of the third trimester patients. The appendix was easily located in 94% of the incisions made through McBurney's point and 80% of the incisions made above McBurney's point. CONCLUSIONS: Our clinical experience indicates that the incision for the removal of the appendix in pregnant patients in all trimesters can be successfully made over McBurney's point.

Does prehospital fluid administration impact core body temperature and coagulation functions in combat casualties?

BACKGROUND: Administration of large amounts of fluids to trauma patients, in the absence of surgical control, may increase bleeding, cause hypothermia and coagulopathy which may worsen the bleeding and increase morbidity and mortality. The purpose of our study is to examine the impact of prehospital fluid administration to military combat casualties on core body temperature and coagulation functions. METHODS: Prospective data were collected on all cases of moderately (9 < or = ISS < or = 14) and severely (ISS > or = 16) injured victims wounded in South Lebanon, treated by Israeli military physicians and evacuated to hospitals in Israel, over a two-year period. Data regarding prehospital phase of injury (timetables, amount of fluids) and upon hospital arrival (initial core body temperature, prothrombin time [PT], partial thromboplastin time [PTT]) were examined for monotonic relation using Spearman's non-parametric test. RESULTS: Fifty-three moderately injured and 31 severely injured patients were included in the study. The average evacuation time for the moderately injured group was 109.3 +/- 44.8 min, and for the severely injured 100.3 +/- 38.4 min (P value=NS). The mean volume of fluids administered was 2.39 +/- 1.52 and 2.49 +/- 1.47 l, respectively (P=NS). No statistical correlation was found between core body temperature, PT or PTT, measured upon hospital arrival, and prehospital fluid treatment. In addition, no correlation was found between core body temperature on hospital arrival and prehospital time, or between prehospital fluid volumes and prehospital time. The mean core body temperature of the moderately injured patients was 36.8 degrees C, and that of severely injured was 35.8 degrees C (P=0.026). CONCLUSIONS: With proper control of blood loss and avoidance of excessive fluid administration, moderately and severely injured combat casualties in 'low intensity conflict' in South Lebanon can be resuscitated with fluid volumes that do not result in a coagulation deficit or hypothermia. The core body temperature on arrival at the hospital is related to the severity of the injury.