Design and rationale of a Prospective, Observational European Multicenter study on the efficacy of acute surgical decompression after traumatic Spinal Cord Injury: the SCI-POEM study

Objectives:Despite many years of research, there is currently no treatment available that results in major neurological or functional recovery after traumatic spinal cord injury (tSCI). In particular, no conclusive data related to the role of the timing of decompressive surgery, and the impact of injury severity on its benefit, have been published to date. This paper presents a protocol that was designed to examine the hypothesized association between the timing of surgical decompression and the extent of neurological recovery in tSCI patients.Study design: The SCI-POEM study is a Prospective, Observational European Multicenter comparative cohort study. This study compares acute (<12 h) versus non-acute (>12 h, <2 weeks) decompressive surgery in patients with a traumatic spinal column injury and concomitant spinal cord injury. The sample size calculation was based on a representative European patient cohort of 492 tSCI patients. During a 4-year period, 300 patients will need to be enrolled from 10 trauma centers across Europe. The primary endpoint is lower-extremity motor score as assessed according to the 'International standards for neurological classification of SCI' at 12 months after injury. Secondary endpoints include motor, sensory, imaging and functional outcomes at 3, 6 and 12 months after injury.Conclusion:In order to minimize bias and reduce the impact of confounders, special attention is paid to key methodological principles in this study protocol. A significant difference in safety and/or efficacy endpoints will provide meaningful information to clinicians, as this would confirm the hypothesis that rapid referral to and treatment in specialized centers result in important improvements in tSCI patients.Spinal Cord advance online publication, 17 April 2012; doi:10.1038/sc.2012.34.

Comparing child product safety concerns with injury incidents : does the evidence support the response?

Background Efficient effective child product safety (PS) responses require data on hazards, injury severity and injury probability. PS responses in Australia largely rely on reports from manufacturers/retailers, other jurisdictions/regulators, or consumers. The extent to which reactive responses reflect actual child injury priorities is unknown. Aims/Objectives/Purpose This research compared PS issues for children identified using data compiled from PS regulatory data and data compiled from health data sources in Queensland, Australia. Methods PS regulatory documents describing issues affecting children in Queensland in 2008–2009 were compiled and analysed to identify frequent products and hazards. Three health data sources (ED, injury surveillance and hospital data) were analysed to identify frequent products and hazards. Results/Outcomes Projectile toys/squeeze toys were the priority products for PS regulators with these toys having the potential to release small parts presenting choking hazards. However, across all health datasets, falls were the most common mechanism of injury, and several of the products identified were not subject to a PS system response. While some incidents may not require a response, a manual review of injury description text identified child poisonings and burns as common mechanisms of injuries in the health data where there was substantial documentation of product-involvement, yet only 10% of PS system responses focused on these two mechanisms combined. Significance/contribution to the field Regulatory data focused on products that fail compliance checks with ‘potential’ to cause harm, and health data identified actual harm, resulting in different prioritisation of products/mechanisms. Work is needed to better integrate health data into PS responses in Australia.

A standing vehicle occupant is likely to sustain a more severe injury than one who has flexed knees in an under‐vehicle explosion : a cadaveric study

The lower limb of military vehicle occupants has been the most injured body part due to undervehicle explosions in recent conflicts. Understanding the injury mechanism and causality of injury severity could aid in developing better protection. Therefore, we tested 4 different occupant postures (seated, brace, standing, standing with knee locked in hyper‐extension) in a simulated under‐vehicle explosion (solid blast) using our traumatic injury simulator in the laboratory; we hypothesised that occupant posture would affect injury severity. No skeletal injury was observed in the specimens in seated and braced postures. Severe, impairing injuries were observed in the foot of standing and hyper‐extended specimens. These results demonstrate that a vehicle occupant whose posture at the time of the attack incorporates knee flexion is more likely to be protected against severe skeletal injury to the lower leg.

Variation in Inpatient Rehabilitation Utilization After Hospitalization for Burn Injury in the United States.

Approximately 45,000 individuals are hospitalized annually for burn treatment. Rehabilitation after hospitalization can offer a significant improvement in functional outcomes. Very little is known nationally about rehabilitation for burns, and practices may vary substantially depending on the region based on observed Medicare post-hospitalization spending amounts. This study was designed to measure variation in rehabilitation utilization by state of hospitalization for patients hospitalized with burn injury. This retrospective cohort study used nationally collected data over a 10-year period (2001 to 2010), from the Healthcare Cost and Utilization Project (HCUP) State Inpatient Databases (SIDs). Patients hospitalized for burn injury (n = 57,968) were identified by ICD-9-CM codes and were examined to see specifically if they were discharged immediately to inpatient rehabilitation after hospitalization (primary endpoint). Both unadjusted and adjusted likelihoods were calculated for each state taking into account the effects of age, insurance status, hospitalization at a burn center, and extent of burn injury by TBSA. The relative risk of discharge to inpatient rehabilitation varied by as much as 6-fold among different states. Higher TBSA, having health insurance, higher age, and burn center hospitalization all increased the likelihood of discharge to inpatient rehabilitation following acute care hospitalization. There was significant variation between states in inpatient rehabilitation utilization after adjusting for variables known to affect each outcome. Future efforts should be focused on identifying the cause of this state-to-state variation, its relationship to patient outcome, and standardizing treatment across the United States.

Social competence following mild head injury and moderate traumatic brain injury: Investigating the neuropsychological relationships between arousal, social decision-making and depression

Client-directed long-term rehabilitative goals and life satisfaction following head injury emphasize the importance of social inclusion, rather than cognitive or physical, outcomes. However, very little research has explored the socio-emotional factors that pose as barriers to social reintegration following injury. This study investigates social barriers following head injury (i.e., decision-making - Iowa Gambling Task [IGT] and mood – depression) and possible amelioration of those challenges (through treatment) in both highly functioning university students with and without mild head injury (MHI) and in individuals with moderate traumatic brain injury (TBI). An arousal manipulation using emotionally evocative stimuli was introduced to manipulate the subject’s physiological arousal state. Seventy-five university students (37.6% reporting a MHI) and 11 patients with documented moderate TBI were recruited to participate in this quasi-experimental study. Those with head injury were found to be physiologically underaroused (on measures of electrodermal activation [EDA] and pulse) and were less sensitive to the negative effects of punishment (i.e., losses) in the gambling task than those without head injury, with greater impairment being observed for the moderate TBI group. The arousal manipulation, while effective, was not able to maintain a higher state of arousal in the injury groups across trials (i.e., their arousal state returned to pre-manipulation levels more quickly than their non-injured cohort), and, subsequently, a performance improvement was not observed on the IGT. Lastly, head injury was found to contribute to the relationship between IGT performance and depressive symptom acknowledgment and mood status in persons with head injury. This study indicates the possible important role of physiological arousal on socio- emotional behaviours (decision-making, mood) in persons with even mild, non-complicated head injuries and across the injury severity continuum.

Rest-activity cycle disturbances in the acute phase of moderate to severe traumatic brain injury

Background. Sleep-wake disturbances are among the most persistent sequelae after traumatic brain injury (TBI) and probably arise during the hospital stay following TBI. These disturbances are characterized by difficulties sleeping at night and staying awake during the day. Objective. The aim of the present study was to document rest-activity cycle consolidation in acute moderate/severe TBI using actigraphy and to assess its association with injury severity and outcome. Methods. In all, 16 hospitalized patients (27.1 ± 11.3 years) with moderate/severe TBI wore actigraphs for 10 days, starting in the intensive care unit (ICU) when continuous sedation was discontinued and patients had reached medical stability. Activity counts were summed for daytime (7:00-21:59 hours) and nighttime periods (22:00-6:59 hours). The ratio of daytime period activity to total 24-hour activity was used to quantify rest-activity cycle consolidation. An analysis of variance was carried out to characterize the evolution of the daytime activity ratio over the recording period. Results. Rest-activity cycle was consolidated only 46.6% of all days; however, a significant linear trend of improvement was observed over time. Greater TBI severity and longer ICU and hospital lengths of stay were associated with poorer rest-activity cycle consolidation and evolution. Patients with more rapid return to consolidated rest-activity cycle were more likely to have cleared posttraumatic amnesia and have lower disability at hospital discharge. Conclusions. Patients with acute moderate/ severe TBI had an altered rest-activity cycle, probably reflecting severe fragmentation of sleep and wake episodes, which globally improved over time. A faster return to rest-activity cycle consolidation may predict enhanced brain recovery.

Return to pre-injury health status and function 12 months after hospitalisation for sport and active recreation related orthopaedic injury

Background Hospitalised sport and active recreation injuries can have serious long-term consequences. Despite this, few studies have examined the long-term outcomes of these injuries. The purpose of this study was to establish whether patients hospitalised with orthopaedic sport and active recreation injuries, have returned to their pre-injury levels of health status and function, 12 months post injury and identify factors associated with poor outcomes. The present work was a cohort study with retrospective assessment of pre-injury status and prospective assessment of outcome at 12 months post injury.

Methods Adults with orthopaedic sport and active recreation injuries, captured by the Victorian Orthopaedic Trauma Outcomes Registry were recruited to the study. Pre-injury and 12-month outcomes were assessed using the 36-item Short Form Health Survey (SF-36) and the extended Glasgow Outcome Scale. Differences in pre-injury and post-injury SF-36 scores were examined and demographic, injury, hospital and physical activity variables were assessed for associations with outcome using multivariate linear regression.

Results Of the 324 participants 98% were followed-up at 12 months post injury. At 12 months, participants reported a mean 7.0-point reduction in physical health (95% CI 5.8 to 7.8) and a 2.5-point reduction in mental health (95% CI 1.2 to 3.0), with 58% (95% CI 52.6% to 63.4%) reporting reduced function. Sporting group (p=0.001), Injury Severity Score >15 (p=0.007) and high pre-injury vigorous activity levels (p=0.04), were related to poorer physical health outcomes.

Conclusions At 12 months post injury, most participants reported large reductions in physical health and reduced function. This information is important for furthering our understanding of the burden of sport and active recreation injury and setting priorities for treatment and rehabilitation.

Long-Term Follow-Up of Patients after Acute Kidney Injury: Patterns of Renal Functional Recovery

Background and Objectives: Patients who survive acute kidney injury (AKI), especially those with partial renal recovery, present a higher long-term mortality risk. However, there is no consensus on the best time to assess renal function after an episode of acute kidney injury or agreement on the definition of renal recovery. In addition, only limited data regarding predictors of recovery are available. Design, Setting, Participants, & Measurements: From 1984 to 2009, 84 adult survivors of acute kidney injury were followed by the same nephrologist (RCRMA) for a median time of 4.1 years. Patients were seen at least once each year after discharge until end stage renal disease (ESRD) or death. In each consultation serum creatinine was measured and glomerular filtration rate estimated. Renal recovery was defined as a glomerular filtration rate value >= 60 mL/min/1.73 m2. A multiple logistic regression was performed to evaluate factors independently associated with renal recovery. Results: The median length of follow-up was 50 months (30-90 months). All patients had stabilized their glomerular filtration rates by 18 months and 83% of them stabilized earlier: up to 12 months. Renal recovery occurred in 16 patients (19%) at discharge and in 54 (64%) by 18 months. Six patients died and four patients progressed to ESRD during the follow up period. Age (OR 1.09, p < 0.0001) and serum creatinine at hospital discharge (OR 2.48, p = 0.007) were independent factors associated with non renal recovery. The acute kidney injury severity, evaluated by peak serum creatinine and need for dialysis, was not associated with non renal recovery. Conclusions: Renal recovery must be evaluated no earlier than one year after an acute kidney injury episode. Nephrology referral should be considered mainly for older patients and those with elevated serum creatinine at hospital discharge.

Epidemiology and predictors of spinal injury in adult major trauma patients: European cohort study

This is a European cohort study on predictors of spinal injury in adult (≥16 years) major trauma patients, using prospectively collected data of the Trauma Audit and Research Network from 1988 to 2009. Predictors for spinal fractures/dislocations or spinal cord injury were determined using univariate and multivariate logistic regression analysis. 250,584 patients were analysed. 24,000 patients (9.6%) sustained spinal fractures/dislocations alone and 4,489 (1.8%) sustained spinal cord injury with or without fractures/dislocations. Spinal injury patients had a median age of 44.5 years (IQR = 28.8-64.0) and Injury Severity Score of 9 (IQR = 4-17). 64.9% were male. 45% of patients suffered associated injuries to other body regions. Age <45 years (≥45 years OR 0.83-0.94), Glasgow Coma Score (GCS) 3-8 (OR 1.10, 95% CI 1.02-1.19), falls >2 m (OR 4.17, 95% CI 3.98-4.37), sports injuries (OR 2.79, 95% CI 2.41-3.23) and road traffic collisions (RTCs) (OR 1.91, 95% CI 1.83-2.00) were predictors for spinal fractures/dislocations. Age <45 years (≥45 years OR 0.78-0.90), male gender (female OR 0.78, 95% CI 0.72-0.85), GCS <15 (OR 1.36-1.93), associated chest injury (OR 1.10, 95% CI 1.01-1.20), sports injuries (OR 3.98, 95% CI 3.04-5.21), falls >2 m (OR 3.60, 95% CI 3.21-4.04), RTCs (OR 2.20, 95% CI 1.96-2.46) and shooting (OR 1.91, 95% CI 1.21-3.00) were predictors for spinal cord injury. Multilevel injury was found in 10.4% of fractures/dislocations and in 1.3% of cord injury patients. As spinal trauma occurred in >10% of major trauma patients, aggressive evaluation of the spine is warranted, especially, in males, patients <45 years, with a GCS <15, concomitant chest injury and/or dangerous injury mechanisms (falls >2 m, sports injuries, RTCs and shooting). Diagnostic imaging of the whole spine and a diligent search for associated injuries are substantial.

Serial lactate and admission SOFA scores in trauma: an analysis of predictive value in 724 patients with and without traumatic brain injury

Objective Arterial lactate, base excess (BE), lactate clearance, and Sequential Organ Failure Assessment (SOFA) score have been shown to correlate with outcome in severely injured patients. The goal of the present study was to separately assess their predictive value in patients suffering from traumatic brain injury (TBI) as opposed to patients suffering from injuries not related to the brain. Materials and methods A total of 724 adult trauma patients with an Injury Severity Score (ISS) ≥ 16 were grouped into patients without TBI (non-TBI), patients with isolated TBI (isolated TBI), and patients with a combination of TBI and non-TBI injuries (combined injuries). The predictive value of the above parameters was then analyzed using both uni- and multivariate analyses. Results The mean age of the patients was 39 years (77 % males), with a mean ISS of 32 (range 16–75). Mortality ranged from 14 % (non-TBI) to 24 % (combined injuries). Admission and serial lactate/BE values were higher in non-survivors of all groups (all p < 0.01), but not in patients with isolated TBI. Admission SOFA scores were highest in non-survivors of all groups (p = 0.023); subsequently septic patients also showed elevated SOFA scores (p < 0.01), except those with isolated TBI. In this group, SOFA score was the only parameter which showed significant differences between survivors and non-survivors. Receiver operating characteristic (ROC) analysis revealed lactate to be the best overall predictor for increased mortality and further septic complications, irrespective of the leading injury. Conclusion Lactate showed the best performance in predicting sepsis or death in all trauma patients except those with isolated TBI, and the differences were greatest in patients with substantial bleeding. Following isolated TBI, SOFA score was the only parameter which could differentiate survivors from non-survivors on admission, although the SOFA score, too, was not an independent predictor of death following multivariate analysis.

The influence of body mass index on injury pattern in polytrauma: thorax as the main source of complications

Background: Obesity is a growing problem in industrial nations. The aim of this study was to determine the relationship between the body mass index (BMI) and the pattern of injury after polytrauma. Methods: This retrospective study included 651 patients with an injury severity score (ISS) ≥16 and aged ≥16 years who were subdivided into three groups: BMI < 25 kg/m2, BMI 25–30 kg/m2, and BMI > 30 kg/m2. The Abbreviated Injury Scale (AIS) was used to quantify the injuries in the different anatomical regions. The Murray score was assessed at admission and at its maximum during hospitalization to evaluate pulmonary problems. Data are presented as means ± standard errors of the means. One way analysis of variance, χ2 test and Kruskal-Wallis test were used for the analyses and the significance level was set at p < 0.05. Results: The AIS of the thorax was 3.2 ± 0.1 in the BMI < 25 kg/m2 group, 3.3 ± 0.1 in the BMI 25–30 kg/m2 group, and 2.8 ± 0.2 in the BMI > 30 kg/m2 group; p < 0.05. The Murray score at admission increased significantly with increasing BMI (0.8 ± 0.8 for BMI < 25 kg/m2, 0.9 ± 0.9 for BMI 25–30 kg/m2, and 1.0 ± 0.8 for BMI > 30 kg/m2; p < 0.05) as was the maximum Murray score during hospitalization (1.2 ± 0.9 for BMI < 25 kg/m2, 1.6 ± 1.0 for BMI 25–30 kg/m2, and 1.5 ± 0.9 for BMI > 30 kg/m2; p < 0.001). The number of ventilator days was also elevated significantly with increasing BMI (5.9 ± 0.4 for BMI < 25 kg/m2, 7.7 ± 0.8 for BMI 25–30 kg/m2, and 7.9 ± 1.6 for BMI > 30 kg/m2; p < 0.05). Conclusion: Overweight and obesity lead to a higher incidence of thoracic trauma in a polytrauma situation and may additionally handicap ventilation in an obstructive manner.

Serum IL-6: a candidate biomarker for intracranial pressure elevation following isolated traumatic brain injury.

BACKGROUND: Increased intracranial pressure (ICP) is a serious, life-threatening, secondary event following traumatic brain injury (TBI). In many cases, ICP rises in a delayed fashion, reaching a maximal level 48-96 hours after the initial insult. While pressure catheters can be implanted to monitor ICP, there is no clinically proven method for determining a patient's risk for developing this pathology. METHODS: In the present study, we employed antibody array and Luminex-based screening methods to interrogate the levels of inflammatory cytokines in the serum of healthy volunteers and in severe TBI patients (GCS RESULTS: Consistent with previous reports, we observed sustained increases in IL-6 levels in TBI patients irrespective of their ICP status. However, the group of patients who subsequently experienced ICP >or= 25 mm Hg had significantly higher IL-6 levels within the first 17 hours of injury as compared to the patients whose ICP remained 128 pg/ml correctly identified 85% of isolated TBI patients who subsequently developed elevated ICP, and values between these cut-off values correctly identified 75% of all patients whose ICP remained CONCLUSIONS: Our results suggest that serum IL-6 can be used for the differential diagnosis of elevated ICP in isolated TBI.

Quantitative MRI of spinal cord injury in a rat model: Correlative studies

Serial quantitative and correlative studies of experimental spinal cord injury (SCI) in rats were conducted using three-dimensional magnetic resonance imaging (MRI). Correlative measures included morphological histopathology, neurobehavioral measures of functional deficit, and biochemical assays for N-acetyl-aspartate (NAA), lactate, pyruvate, and ATP. A spinal cord injury device was characterized and provided a reproducible injury severity. Injuries were moderate and consistent to within $\pm$20% (standard deviation). For MRI, a three-dimensional implementation of the single spin-echo FATE (Fast optimum angle, short TE) pulse sequence was used for rapid acquisition, with a 128 x 128 x 32 (x,y,z) matrix size and a 0.21 x 0.21 x 1.5 mm resolution. These serial studies revealed a bimodal characteristic in the evolution in MRI pathology with time. Early and late phases of SCI pathology were clearly visualized in $T\sb2$-weighted MRI, and these corresponded to specific histopathological changes in the spinal cord. Centralized hypointense MRI regions correlated with evidence of hemorrhagic and necrotic tissue, while surrounding hyperintense regions represented edema or myelomalacia. Unexpectedly, $T\sb2$-weighted MRI pathology contrast at 24 hours after injury appeared to subside before peaking at 72 hours after injury. This change is likely attributable to ongoing secondary injury processes, which may alter local $T\sb2$ values or reduce the natural anisotropy of the spinal cord. MRI, functional, and histological measures all indicated that 72 hours after injury was the temporal maximum for quantitative measures of spinal cord pathology. Thereafter, significant improvement was seen only in neurobehavioral scores. Significant correlations were found between quantitated MRI pathology and histopathology. Also, NAA and lactate levels correlated with behavioral measures of the level of function deficit. Asymmetric (rostral/caudal) changes in NAA and lactate due to injury indicate that rostral and caudal segments from the injury site are affected differently by the injury. These studies indicate that volumetric quantitation of MRI pathology from $T\sb2$-weighted images may play an important role in early prediction of neurologic deficit and spinal cord pathology. The loss of $T\sb2$ contrast at 24 hours suggests MR may be able to detect certain delayed mechanisms of secondary injury which are not resolved by histopathology or other radiological modalities. Furthermore, in vivo proton magnetic resonance spectroscopy (MRS) studies of SCI may provide a valuable addition source of information about changes in regional spinal cord lactate and NAA levels, which are indicative of local metabolic and pathological changes. ^

Lateral impact in closed head injury: A substantially increased risk for diffuse axonal injury—A preliminary study

OBJECTIVE: Assessment, whether location of impact causing different facial fracture patterns was associated with diffuse axonal injury in patients with severe closed head injury. METHODS: Retrospectively all patients referred to the Trauma Unit of the University Hospital of Zurich, Switzerland between 1996 and 2002 presenting with severe closed head injuries (Abbreviated Injury Scale (AIS) (face) of 2-4 and an AIS (head and neck) of 3-5) were assessed according to the Glasgow Coma Scale (GCS) and the Injury Severity Score (ISS). Facial fracture patterns were classified as resulting from frontal, oblique or lateral impact. All patients had undergone computed tomography. The association between impact location and diffuse axonal injury when correcting for the level of consciousness (using the Glasgow scale) and severity of injury (using the ISS) was calculated with a multivariate regression analysis. RESULTS: Of 200 screened patients, 61 fulfilled the inclusion criteria for severe closed head injury. The medians (interquartile ranges 25;75) for GCS, AIS(face) AIS(head and neck) and ISS were 3 (3;13), 2 (2;4), 4 (4;5) and 30 (24;41), respectively. A total of 51% patients had frontal, 26% had an oblique and 23% had lateral trauma. A total of 21% patients developed diffuse axonal injury (DAI) when compared with frontal impact, the likelihood of diffuse axonal injury increased 11.0 fold (1.7-73.0) in patients with a lateral impact. CONCLUSIONS: Clinicians should be aware of the substantial increase of diffuse axonal injury related to lateral impact in patients with severe closed head injuries.

Special training in injury coding. Final report.

National Highway Traffic Safety Administration, Washington, D.C.