Emergency Resuscitation of Patients Enrolled in the US Diaspirin Cross-linked Hemoglobin (DCLHb) Clinical Efficacy Trial.

INTRODUCTION: Optimal emergent management of traumatic hemorrhagic shock patients requires a better understanding of treatment provided in the prehospital/Emergency Medical Services (EMS) and emergency department (ED) settings. Hypothesis/Problem Described in this research are the initial clinical status, airway management, fluid and blood infusions, and time course of severely-injured hemorrhagic shock patients in the EMS and ED settings from the diaspirin cross-linked hemoglobin (DCLHb) clinical trial. METHODS: Data were analyzed from 17 US trauma centers gathered during a randomized, controlled, single-blinded efficacy trial of a hemoglobin solution (DCLHb) as add-on therapy versus standard therapy. RESULTS: Among the 98 randomized patients, the mean EMS Glasgow Coma Scale (GCS) was 10.6 (SD = 5.0), the mean EMS revised trauma score (RTS) was 6.3 (SD = 1.9), and the mean injury severity score (ISS) was 31 (SD = 17). Upon arrival to the ED, the GCS was 20% lower (7.8 (SD = 5.3) vs 9.7 (SD = 6.3)) and the RTS was 12% lower (5.3 (SD = 2.0) vs 6.0 (SD = 2.1)) than EMS values in blunt trauma patients (P < .001). By ED disposition, 80% of patients (78/98) were intubated. Rapid sequence intubation (RSI) was utilized in 77% (60/78), most often utilizing succinylcholine (65%) and midazolam (50%). The mean crystalloid volume infused was 4.2 L (SD = 3.4 L), 80% of which was infused within the ED. Emergency department blood transfusion occurred in 62% of patients, with an average transfused volume of 1.2 L (SD = 2.0 L). Blunt trauma patients received 2.1 times more total fluids (7.4 L vs 3.5 L, < .001) and 2.4 times more blood (2.4 L vs 1.0 L, P < .001). The mean time of patients taken from injury site to operating room (OR) was 113 minutes (SD = 87 minutes). Twenty-one (30%) of the 70 patients taken to the OR from the ED were sent within 60 minutes of the estimated injury time. Penetrating trauma patients were taken to the OR 52% sooner than blunt trauma patients (72 minutes vs 149 minutes, P < .001). CONCLUSION: Both GCS and RTS decreased prior to ED arrival in blunt trauma patients. Intubation was performed using RSI, and crystalloid infusion of three times the estimated blood loss volume (L) and blood transfusion of the estimated blood loss volume (L) were provided in the EMS and ED settings. Surgical intervention for these trauma patients most often occurred more than one hour from the time of injury. Penetrating trauma patients received surgical intervention more rapidly than those with a blunt trauma mechanism.

Shock index and prediction of traumatic hemorrhagic shock 28-day mortality: data from the DCLHb resuscitation clinical trials.

INTRODUCTION: To assess the ability of the shock index (SI) to predict 28-day mortality in traumatic hemorrhagic shock patients treated in the diaspirin cross-linked hemoglobin (DCLHb) resuscitation clinical trials. METHODS: We used data from two parallel DCLHb traumatic hemorrhagic shock efficacy trials, one in U.S. emergency departments, and one in the European Union prehospital setting to assess the relationship between SI values and 28-day mortality. RESULTS: In the 219 patients, the mean age was 37 years, 64% sustained a blunt injury, 48% received DCLHb, 36% died, and 88% had an SI≥1.0 at study entry. The percentage of patients with an SI≥1.0 dropped by 57% (88 to 38%) from the time of study entry to 120 minutes after study resuscitation (p<0.001). Patients with a SI≥1.0, 1.4, and 1.8 at any time point were 2.3, 2.7, and 3.1 times, respectively, more likely to die by 28 days than were patients with SI values below these cutoffs (p<0.001). Similarly, after 120 minutes of resuscitation, patients with a SI≥1.0 were 3.9× times more likely to die by 28 days (40 vs. 15%, p<0.001). Although the distribution of SI values differed based on treatment group, the receiver operator characeristics data showed no difference in SI predictive ability for 28-day mortality in patients treated with DCLHb. CONCLUSION: In these traumatic hemorrhagic shock patients, the shock index correlates with 28-day mortality, with higher SI values indicating greater mortality risk. Although DCLHb treatment did alter the distribution of SI values, it did not influence the ability of the SI to predict 28-day mortality.

The use of the Revised Trauma Score as an entry criterion in traumatic hemorrhagic shock studies: data from the DCLHb clinical trials.

INTRODUCTION: The Revised Trauma Score (RTS) has been proposed as an entry criterion to identify patients with mid-range survival probability for traumatic hemorrhagic shock studies. HYPOTHESIS/PROBLEM: Determination of which of four RTS strata (1-3.99, 2-4.99, 1-4.99, and 2-5.99) identifies patients with predicted and actual mortality rates near 50% for use as an entry criterion in traumatic hemorrhagic shock clinical trials. METHODS: Existing database analysis in which demographic and injury severity data from two prior international Diaspirin Cross-Linked Hemoglobin (DCLHb) clinical trials were used to identify an RTS range that could be an optimal entry criterion in order to find the population of trauma patients with mid-range predicted and actual mortality rates. RESULTS: Of 208 study patients, the mean age was 37 years, 65% sustained blunt trauma, 49% received DCLHb, and 57% came from the European Union study arm. The mean values were: ISS, 31 (SD = 18); RTS, 5.6 (SD = 1.8); and Glasgow Coma Scale (GCS), 10.4 (SD = 4.8). The mean TRISS-predicted mortality was 34% and the actual 28-day mortality was 35%. The initially proposed 1-3.99 RTS range (n = 41) had the highest predicted (79%) and actual (71%) mortality rates. The 2-5.99 RTS range (n = 79) had a 62% predicted and 53% actual mortality, and included 76% blunt trauma patients. Removal of GCS <5 patients from this RTS 2-5.99 subgroup caused a 48% further reduction in eligible patients, leaving 41 patients (20% of 208 total patients), 66% of whom sustained a blunt trauma injury. This subgroup had 54% predicted and 49% actual mortality rates. Receiver operator curve (ROC) analysis found the GCS to be as predictive of mortality as the RTS, both in the total patient population and in the RTS 2-5.99 subgroup. CONCLUSION: The use of an RTS 2-5.99 inclusion criterion range identifies a traumatic hemorrhagic shock patient subgroup with predicted and actual mortality that approach the desired 50% rate. The exclusion of GCS <5 from this RTS 2-5.99 subgroup patients yields a smaller, more uniform patient subgroup whose mortality is more likely related to hemorrhagic shock than traumatic brain injury. Future studies should examine whether the RTS or other physiologic criteria such as the GCS score are most useful as traumatic hemorrhagic shock study entry criteria.

National Stroke Association recommendations for systems of care for transient ischemic attack.

Transient ischemic attacks (TIAs) are common and portend a high short-term risk of stroke. Evidence-based recommendations for the urgent evaluation and treatment of patients with TIA have been published. However, implementation of these recommendations reliably and consistently will require changes in the systems of care established for TIA. The National Stroke Association convened a multidisciplinary panel of experts to develop recommendations for the essential components of systems of care at hospitals to improve the quality of care provided to patients with TIA. The panel recommends that hospitals establish standardized protocols to assure rapid and complete evaluation and treatment for patients with TIA, with particular attention to urgency and close observation in patients at high risk of stroke.

Diaspirin cross-linked hemoglobin infusion did not influence base deficit and lactic acid levels in two clinical trials of traumatic hemorrhagic shock patient resuscitation.

BACKGROUND: Diaspirin cross-linked hemoglobin (DCLHb) has demonstrated a pressor effect that could adversely affect traumatic hemorrhagic shock patients through diminished perfusion to vital organs, causing base deficit (BD) and lactate abnormalities. METHODS: Data from two parallel, multicenter traumatic hemorrhagic shock clinical trials from 17 US Emergency Departments and 27 European Union prehospital services using DCLHb, a hemoglobin-based resuscitation fluid. RESULTS: In the 219 patients, the mean age was 37.3 years, 64% of the patients sustained a blunt injury, 48% received DCLHb resuscitation, and the overall 28-day mortality rate was 36.5%. BD data did not differ by treatment group (DCLHb vs. normal saline [NS]) at any time point. Study entry BD was higher in patients who died when compared with survivors in both studies (US: -14.7 vs. -9.3 and European Union: -11.1 vs. -4.1 mEq/L, p < 0.003) and at the first three time points after resuscitation. No differences in BD based on treatment group were observed in either those who survived or those who died from the hemorrhagic shock. US lactate data did not differ by treatment group (DCLHb vs. NS) at any time point. Study entry lactates were higher in US patients who ultimately died when compared with survivors (82.4 vs. 56.1 mmol/L, p < 0.003) and at all five postresuscitation time points. No lactate differences were observed between DCLHb and NS survivors or in those who died based on treatment group. CONCLUSIONS: Although patients who died had more greatly altered perfusion than those who survived, DCLHb treatment of traumatic hemorrhagic shock patients was not associated with BD or lactate abnormalities that would indicate poor perfusion.

The lack of consistent diaspirin cross-linked hemoglobin infusion blood pressure effects in the US and EU traumatic hemorrhagic shock clinical trials.

Hemoglobin solutions have demonstrated a pressor effect that could adversely affect hemorrhagic shock patient resuscitation through accelerated hemorrhage, diminished perfusion, or inadequate resuscitation. Data from two parallel, multicenter traumatic hemorrhagic shock clinical trials in 17 US emergency departments and in 27 EU prehospital systems using diaspirin cross-linked hemoglobin (DCLHb), a hemoglobin-based resuscitation fluid. In the 219 patients, patients were 37 years old, 64% sustained blunt injury, 48% received DCLHb, and 36% expired. Although mean systolic blood pressure (SBP) and diastolic blood pressure values differed at 2 of the 10 measured time points, blood pressure (BP) curve analysis showed no SBP, diastolic blood pressure, or MAP differences based on treatment. Although SBP values 160 and 120 mmHg or greater were 2.2x and 2.6x more frequently noted in survivors, they were not more common with DCLHb use or in DCLHb patients who expired in US study nonsurvivors or in any EU study patients. Systolic blood pressure values 160 and 120 mmHg or greater were 2.8x and 1.3x more frequently noted in DCLHb survivors as compared with normal saline survivors. Only 3% of the BP variation noted could be attributed to DCLHb use, and as expected, injury severity and baseline physiologic status were stronger predictors. In the United States alone, treatment group was not correlated by regression with BP at any time point. Neither mean BP readings nor elevated BP readings were correlated with DCLHb treatment of traumatic hemorrhagic shock patients. As such, no clinically demonstrable DCLHb pressor effect could be directly related to the adverse mortality outcome observed in the US study.

Emergency department evaluation and management of stroke: acute assessment, stroke teams and care pathways.

The emergency department (ED) is the entry point into the health care system for many stroke victims. Rapid evaluation, diagnosis and treatment of stroke in the prehospital setting as well as the ED are integral to preventing morbidity and mortality. In some centers, emergency medicine physicians are the health care professionals most often able to provide thrombolytic therapy to stroke patients during the brief three-hour window for this therapy. An organized ED approach including implementing stroke care pathways and collaborating with specialized stroke teams in the ED enhance the ability to identify and manage stroke patients effectively. This approach has the potential to improve outcomes on a large scale.

Clinical policy: critical issues in the management of adult patients presenting to the emergency department with acute carbon monoxide poisoning.

This clinical policy focuses on critical issues concerning the management of adult patients presenting to the emergency department (ED) with acute symptomatic carbon monoxide (CO) poisoning. The subcommittee reviewed the medical literature relevant to the questions posed. The critical questions are: Should hyperbaric oxygen (HBO(2)) therapy be used for the treatment of patients with acute CO poisoning; and Can clinical or laboratory criteria identify CO-poisoned patients who are most or least likely to benefit from this therapy? Recommendations are provided on the basis of the strength of evidence of the literature. Level A recommendations represent patient management principles that reflect a high degree of clinical certainty; Level B recommendations represent patient management principles that reflect moderate clinical certainty; and Level C recommendations represent other patient management strategies that are based on preliminary, inconclusive, or conflicting evidence, or based on committee consensus. This clinical policy is intended for physicians working in hospital-based EDs.

Clinical policy: critical issues in the management of patients presenting to the emergency department with acetaminophen overdose.

This clinical policy focuses on critical issues concerning the management of patients presenting to the emergency department (ED) with acetaminophen overdose. The subcommittee reviewed the medical literature relevant to the questions posed. The critical questions are: 1. What are the indications for N-acetylcysteine (NAC) in the acetaminophen overdose patient with a known time of acute ingestion who can be risk stratified by th Rumack-Matthew nomogram? 2. What are the indications for NAC in the acetaminophen overdose patient who cannot be risk stratified by the Rumack-Matthew nomogram? Recommendations are provided on the basis of the strength of evidence of the literature. Level A recommendations represent patient management principles that reflect a high degree of clinical certainty; Level B recommendations represent patient management principles that reflect moderate clinical certainty; and Level C recommendations represent other patient management strategies that are based on preliminary, inconclusive, or conflicting evidence, or based on committee consensus. This guideline is intended for physicians working in EDs.

Clinical policy: Critical issues in the management of adult patients presenting to the emergency department with acute carbon monoxide poisoning.

This clinical policy focuses on critical issues concerning the management of adult patients presenting to the emergency department (ED) with acute symptomatic carbon monoxide (CO) poisoning. The subcommittee reviewed the medical literature relevant to the questions posed. The critical questions are: Should hyperbaric oxygen (HBO2) therapy be used for the treatment of patients with acute CO poisoning; and Can clinical or laboratory criteria identify CO-poisoned patients who are most or least likely to benefit from this therapy. Recommendations are provided on the basis of the strength of evidence of the literature. Level A recommendations represent patient management principles that reflect a high degree of clinical certainty; Level B recommendations represent patient management principles that reflect moderate clinical certainty; and Level C recommendations represent other patient management strategies that are based on preliminary, inconclusive, or conflicting evidence, or based on committee consensus. This clinical policy is intended for physicians working in hospital-based EDs.

Clinical policy: critical issues in the management of patients presenting to the emergency department with acetaminophen overdose.

This clinical policy focuses on critical issues concerning the management of patients presenting to the emergency department (ED) with acetaminophen overdose. The subcommittee reviewed the medical literature relevant to the questions posed. The critical questions are: 1. What are the indications for N-acetylcysteine (NAC) in the acetaminophen overdose patient with a known time of acute ingestion who can be risk stratified by the Rumack-Matthew nomogram? 2. What are the indications for NAC in the acetaminophen overdose patient who cannot be risk stratified by the Rumack-Matthew nomogram? Recommendations are provided on the basis of the strength of evidence of the literature. Level A recommendations represent patient management principles that reflect a high degree of clinical certainty; Level B recommendations represent patient management principles that reflect moderate clinical certainty; and Level C recommendations represent other patient management strategies that are based on preliminary, inconclusive, or conflicting evidence, or based on committee consensus. This guideline is intended for physicians working in EDs.

Myocardial infarction and cardiac complications in emergency department patients admitted to the intensive care unit with gastrointestinal hemorrhage.

Patients admitted with significant gastrointestinal hemorrhage (GIH) often experience in-hospital cardiac complications. This retrospective study examined 68 patients admitted from the Emergency Department to the Intensive Care Unit (ICU) over a 1-year period. The patients were 75% Caucasian, 60% male, with a mean age of 57 +/- 19 years. Medical co-morbidity was noted in 70%, and 54% of patients had a history of significant alcohol use. A systolic blood pressure < 100 mm Hg was present in 26%, hemoglobin < 7 mg/dL in 32%, and three patients (4%) expired. Death, acute myocardial infarction or other cardiac complications were noted in 32% of patients. Patients older than 60 years were three times more likely to have a complicated course than were younger patients, and those with a co-morbidity were 14.8 times more likely. Patients with a history of significant alcohol use were 31% less likely to have an inpatient complication than those without such a history. Regression analysis supported the protective effect of a history of significant alcohol use and also demonstrated that a history of peptic ulcer disease was predictive of inpatient complications. Older GIH patients and those with co-morbidities may benefit from ICU disposition given their greater risk. Younger patients presenting with hematemesis and a history of significant alcohol use tended to have fewer complications such that it may be possible to manage these patients outside of the ICU if hemodynamically stable.

Comparison of the New Injury Severity Score and the Injury Severity Score.

BACKGROUND: The New Injury Severity Score (NISS) was proposed in 1997 to replace the Injury Severity Score (ISS) because it is more sensitive for mortality. We aim to test whether this is true in our patients. METHODS: This study was a retrospective review of data from 6,231 consecutive patients over 3 years in the trauma registry of a Level I trauma center studying outcome, ISS, and NISS. RESULTS: Misclassification rates were 3.97% for the NISS and 4.35% for the ISS. The receiver operating characteristic curve areas were 0.936 and 0.94, respectively. Neither the ISS nor the NISS were well calibrated (Hosmer-Lemeshow statistic, 36.11 and 49.28, respectively; p < 0.001). CONCLUSION: The NISS should not replace the ISS, as they share similar accuracy and calibration.

Documentation of ED patient pain by nurses and physicians.

The purpose of this study was to evaluate ED documentation of patient pain in light of the Joint Commission of Accreditation of Healthcare Organization's emphasis on pain assessment and management. A prospectively designed pain management survey was offered to patients on ED discharge. Documentation of pain intensity by ED nurses and physicians was retrospectively reviewed. Of 302 patients surveyed, 261 (86%) complete charts were available for review. Initial pain assessments were noted on 94% of the charts, but a pain scale was used for only 23% of the patients. Documentation of pain subsequent to therapy was noted on 39% of the charts, but a pain scale was used only 19% of the time. Subsequent to therapy, nurses were 2.2 x more likely to document pain assessments than physicians (30% vs 16%, P <.001). Patients with severe pain on arrival (46% vs 31%, odds ratio [OR] = 1.9, P <.02), chest pain (72% vs 32%, OR = 5.4, P <.001), or those receiving powerful analgesics (62% vs 32%, 3.5, P <.001) were more likely to receive a documented subsequent pain assessment than other patients. Pain severity is not consistently documented in ED patients, especially after therapy has been provided. Patients with severe pain and those receiving powerful analgesics were more likely to have a pain assessment subsequent to ED therapy.

Variation in patient management based on ECG interpretation by emergency medicine and internal medicine residents.

This study was performed to determine the impact of electrocardiogram (ECG) interpretation on urgent patient care decisions by internal medicine (IM) and emergency medicine (EM) resident physicians. Six clinical scenarios and ECGs were given to 31 IM residents and 31 EM residents at a university medical center. Based on the ECG interpretation, the residents were asked to select the best patient management from a list of choices. IM and EM residents were equally likely to choose the correct management for complete heart block (90% IM v 97% EM, P = NS), and pulseless ventricular tachycardia (VT) (94% IM v 97% EM, P = NS). IM residents were less likely to choose the correct management for acute posterior wall myocardial infarction (MI) (26% IM v 74% EM, P <.0001) and unstable supraventricular tachycardia (SVT) (87% IM v 100% EM, P <.05). Residents in both programs were equally likely to misinterpret left ventricular hypertrophy (LVH) (23% IM and 16% EM, P = NS) and benign early repolarization (BER) (48% IM and 52% EM, P = NS) as acute myocardial ischemia when presented with a clinical history not suggestive of cardiac ischemia. IM and EM residents were equally likely to choose the correct management for complete heart block and pulseless VT. Compared with EM residents, IM residents were less likely to choose the correct management of posterior wall MI and unstable SVT. Both IM and EM residents were prone to misinterpreting LVH and BER as acute myocardial ischemia. Resident education in both specialties should focus on ECG interpretation skills to improve patient management decisions.

Post hoc mortality analysis of the efficacy trial of diaspirin cross-linked hemoglobin in the treatment of severe traumatic hemorrhagic shock.

BACKGROUND: The efficacy trial of diaspirin cross-linked hemoglobin (DCLHb) in traumatic hemorrhagic shock demonstrated an unexpected mortality imbalance, prompting a three-step review to better understand the cause of this finding. METHODS: Patients were enrolled in this DCLHb hemorrhagic shock study using 28-day mortality as the primary endpoint. Mortality data were primarily analyzed using the TRISS method and a nonblinded clinical review, followed by an independent Pennsylvania Trauma Outcome Study (PTOS)-derived probability of survival analyses. Finally, a trauma expert conducted a blinded clinical review of cases incorrectly predicted by these PTOS analyses. RESULTS: More of the DCLHb patients predicted to survive using TRISS actually died than in the control subgroup (24% vs. 3%, p < 0.002). Nonblinded clinical review noted that 72% of the patients who died had prior traumatic arrest, a presenting Glasgow Coma Scale score of 3, or a base deficit > 15 mEq/L. DCLHb patients predicted to survive using PTOS also more often died than did control patients (30% vs. 8%, p < 0.04). Blinded clinical review determined that 94% of the deaths were clinically justified. Both the TRISS and the PTOS models gave an adjusted mortality relative risk of 2.3, similar to the unadjusted risk data. CONCLUSION: Mortality analysis in this shock study involved both clinical case reviews and mortality prediction models. Despite the observation that nearly all of the deaths were clinically justified, the TRISS and PTOS models demonstrated excess unpredicted deaths in the DCLHb subgroup. A combined process, using both mortality prediction models and clinical case reviews, is useful in trauma studies that use a mortality endpoint.