Adverse effects of prolonged hyperventilation in patients with severe head injury: a randomized clinical trial. Routine follow up after head injury: a second randomised controlled trial. Does routine follow up after head injury help? A randomised controlled trial. Effect of intracranial pressure monitoring and aggressive treatment on mortality in severe head injury. The impact of motorcycle helmet use. High-dose barbiturate control of elevated intracranial pressure in patients with severe head injury. Failure of the competitive N-methyl-D-aspartate antagonist Selfotel (CGS 19755) in the treatment of severe head injury: results of two phase III clinical trials. The Selfotel Investigators. The impact of aeromedical response to patients with moderate to severe traumatic brain injury. Motorcycle trauma in the state of Illinois: analysis of the Illinois Department of Public Health Trauma Registry. [Head injuries in traffic accidents with emphasis on the comparisons between motorcycle-helmet users and non-users]. The association of helmet use with the outcome of motorcycle crash injury when controlling for crash/injury severity.
There is still controversy over whether or not patients should be hyperventilated after traumatic brain injury, and a randomized trial has never been conducted. The theoretical advantages of hyperventilation are cerebral vasoconstriction for intracranial pressure (ICP) control and reversal of brain and cerebrospinal fluid (CSF) acidosis. Possible disadvantages include cerebral vasoconstriction to such an extent that cerebral ischemia ensues, and only a short-lived effect on CSF pH with a loss of HCO3-buffer from CSF. The latter disadvantage might be overcome by the addition of the buffer tromethamine (THAM), which has shown some promise in experimental and clinical use. Accordingly, a trial was performed with patients randomly assigned to receive normal ventilation (PaCO2 35 +/- 2 mm Hg (mean +/- standard deviation): control group), hyperventilation (PaCO2 25 +/- 2 mm Hg: HV group), or hyperventilation plus THAM (PaCO2 25 +/- 2 mm Hg: HV + THAM group). Stratification into subgroups of patients with motor scores of 1-3 and 4-5 took place. Outcome was assessed according to the Glasgow Outcome Scale at 3, 6, and 12 months. There were 41 patients in the control group, 36 in the HV group, and 36 in the HV + THAM group. The mean Glasgow Coma Scale score for each group was 5.7 +/- 1.7, 5.6 +/- 1.7, and 5.9 +/- 1.7, respectively; this score and other indicators of severity of injury were not significantly different. A 100% follow-up review was obtained. At 3 and 6 months after injury the number of patients with a favorable outcome (good or moderately disabled) was significantly (p less than 0.05) lower in the hyperventilated patients than in the control and HV + THAM groups. This occurred only in patients with a motor score of 4-5. At 12 months posttrauma this difference was not significant (p = 0.13). Biochemical data indicated that hyperventilation could not sustain alkalinization in the CSF, although THAM could. Accordingly, cerebral blood flow (CBF) was lower in the HV + THAM group than in the control and HV groups, but neither CBF nor arteriovenous difference of oxygen data indicated the occurrence of cerebral ischemia in any of the three groups. Although mean ICP could be kept well below 25 mm Hg in all three groups, the course of ICP was most stable in the HV + THAM group. It is concluded that prophylactic hyperventilation is deleterious in head-injured patients with motor scores of 4-5.(ABSTRACT TRUNCATED AT 400 WORDS) To confirm that patients admitted to hospital with a head injury benefit from a routinely offered early intervention service.
                A mixed rural and urban Health District of 560000 people with two accident and emergency departments provided the setting. Existing routine services for most patients with head injury are minimal. All patients aged 16-65 years admitted to hospital after a head injury of any severity, with or without other injuries entered the trial. Prospective randomisation, with a block randomisation procedure was used to allocate all eligible patients to either: a group offered an additional service by a specialist team; or a group receiving existing standard services. Patients were assessed at follow up six months after injury. The primary outcome measure was the Rivermead head injury follow up questionnaire, a validated and reliable measure of social disability. The Rivermead post-concussion symptoms questionnaire was used to estimate severity of post-concussion symptoms. Each patient in the trial group was contacted 7-10 days after injury, and offered assessment and interventions as needed. These initially focused on the provision of information, support, and advice. Forty six per cent of patients in the trial group also received further outpatient intervention or additional support by telephone.
                314 patients were registered: 184 were randomised into the trial group, 130 into the control group. For prognostic data, the groups were comparable at randomisation, and remained comparable when assessed at six months. 132 trial and 86 control patients were followed up at six months after injury. Patients' posttraumatic amnesia ranged from mild (n=79, 40%), and moderate (n=62, 32%), to severe (n=38, 19%) and very severe (n=17, 9%). The trial group patients had significantly less social disability (p=0.01) and significantly less severe post-concussion symptoms (p=0.02) at follow up at six months after injury than the control group patients.
                The early interventions offered by a specialist service significantly reduced social morbidity and severity of post-concussion symptoms in trial group patients at six months after head injury. Recommendations about how specialist services should be targeted are made both in the light of these results and those from a previous randomised controlled trial. To evaluate the Medical Disability Society's 1988 recommendation that "every patient attending hospital after a head injury should be registered and offered an outpatient follow up appointment" by determining whether offering a routine follow up service to patients presenting to hospital with a head injury of any severity affects outcome six months later.
                A randomised controlled trial design with masked assessment of outcome.
                A mixed rural and urban health district with a population of about 560000.
                1156 consecutive patients resident in Oxfordshire aged between 16 and 65 years presenting over 13 months to accident and emergency departments or admitted to hospital and diagnosed as having a head injury of any severity, including those with other injuries.
                Patients were registered and randomised to one of two groups. Both groups continued to receive the standard service offered by the hospitals. The early follow up group were approached at 7-10 days after injury and offered additional information, advice, support, and further intervention as needed. All randomised patients were approached for follow up assessment six months after injury by independent clinicians blind to their group.
                Validated questionnaires were used to elicit ratings of post-concussion symptoms (the Rivermead postconcussion symptoms questionnaire), and changes in work, relationships, leisure, social, and domestic activities (the Rivermead head injury follow up questionnaire).
                The two groups were comparable at randomisation. Data was obtained at six months on 226 of 577 "control" patients and 252 of 579 "trial" patients (59% were lost to follow up). There were no significant differences overall between the trial and control groups at follow up, but subgroup analysis of the patients with moderate or severe head injuries (posttraumatic amnesia > or = one hour, or admitted to hospital), showed that those in the early intervention group had significantly fewer difficulties with everyday activities (P = 0.03).
                The results from the 41% of patients followed up do not support the recommendation of offering a routine follow up to all patients with head injury, but they do suggest that routine follow up is most likely to be beneficial to patients with moderate or severe head injuries. Some of those with less severe injuries do continue to experience difficulties and need access to services. A further trial is under way to test these conclusions. During 1977-1978, 127 patients with severe head injury were admitted and underwent intracranial pressure (ICP) monitoring. All patients had Glasgow Coma Scale (GCS) scores of 7 or less. All received identical initial treatment according to a standardized protocol. The patients' average age was 29 years; 60% had multiple trauma, and 35% needed emergency intracranial operations. Treatment for elevations of ICP was begun when ICP rose to 20 to 25 mm Hg, and included mannitol therapy and drainage of cerebrospinal fluid (CSF) when possible. Forty-three patients (34%) had ICP greater than or equal to 25 mm Hg; of these, 36 (84%) died. The mortality rate of the entire group was 46%. During 1979-1980, 106 patients with severe head injury were admitted and underwent ICP monitoring. Their average ager was 29 years; 51% had multiple trauma, and 31% underwent emergency intracranial surgery. All patients received the same standardized protocol as the previous series, with the exception of the treatment of ICP. In this present series: if ICP was 15 mm Hg or less (normal ICP), patients were continued on hyperventilation, steroids, and intensive care; if ICP was 16 to 24 mm Hg, mannitol was administered and CSF was drained; if ICP was 25 mm Hg or greater, the patients were randomized into a controlled barbiturate therapy study. Twenty-six patients (25%) had ICP's of 25 mm Hg or greater, compared to 34% in the previous series (p less than 0.05), and 18 of these 26 patients (69%) died. The overall mortality for this current series was 28% compared to 46% in the previous series (p less than 0.0005). This study reconfirms the high mortality rate if ICP is 25 mm Hg or greater; however, the data also document that early aggressive treatment based on ICP monitoring significantly lessens the incidence of ICP of 25 mm Hg or greater and reduces the overall mortality rate of severe head injury. Mandatory motorcycle helmet-use legislation is supported by the high morbidity of motorcycle trauma and its cost to society. Opponents argue, however, that the majority of motorcycle trauma morbidity and costs are the result of injuries to body regions other than the head. Previous data do not address this argument because they fail to control for differences in non-head injury severity (i.e., kinetic impact) between helmeted and unhelmeted patients. This study investigates the impact of helmet use on the morbidity and cost of motorcycle trauma, after controlling for non-head injuries. A retrospective review of all patients admitted to Harborview Medical Center with motorcycle trauma from 1/1/85 to 1/1/90 was performed. Non-head injury severity was determined by calculating an ISS that did not include head injury. This non-head ISS was used to control for injury severity below the neck. Four hundred twenty-five patients were identified. Stratified analysis showed that helmet use decreased the need for and duration of mechanical ventilation, the length of ICU stay, the need for rehabilitation, and prevented head injury. Costs of acute care were significantly less in helmeted patients. Regression analysis, controlling for age, gender, and blood alcohol level (as well as non-head injury severity), confirmed that acute costs were 40% less with helmet use. In a five-center study, 73 patients with severe head injury and elevated intracranial pressure (ICP) were randomly assigned to receive either a regimen that included high-dose pentobarbital or one that was otherwise similar but did not include pentobarbital. The results indicated a 2:1 benefit for those treated with the drug with regard to ICP control. When patients were stratified by prerandomization cardiac complications, the advantage increased to 4:1. A multiple logistic model considering treatment and selected baseline variables indicated a significant positive treatment effect of barbiturates, a significant effect of time from injury to randomization, and an interaction of treatment with cardiovascular complications. However, of 925 patients potentially eligible for randomization, only 12% met ICP randomization criteria. The results support the hypothesis that high-dose pentobarbital is an effective adjunctive therapy, but that it is indicated in only a small subset of patients with severe head injury. Excessive activity of excitatory amino acids released after head trauma has been demonstrated to contribute to progressive injury in animal models and human studies. Several pharmacological agents that act as antagonists to the glutamate receptor have shown promise in limiting this progression. The efficacy of the N-methyl-D-aspartate receptor antagonist Selfotel (CGS 19755) was evaluated in two parallel studies of severely head injured patients, defined as patients with post resuscitation Glasgow Coma Scale scores of 4 to 8.
                A total of 693 patients were prospectively enrolled in two multicenter double-blind studies. Comparison between the treatment groups showed no significant difference with regard to demographic data, previous incidence of hypotension, and severity of injury. As the study progressed, the Safety and Monitoring Committee became concerned about possible increased deaths and serious brain-related adverse events in the treatment arm of the two head injury trials, as well as deaths in the two stroke trials being monitored concurrently. The Selfotel trials were stopped prematurely because of this concern and because an interim efficacy analysis indicated that the likelihood of demonstrating success with the agent if the studies had been completed was almost nil.
                Subsequently, more complete data analysis revealed no statistically significant difference in mortality rates in all cases between the two treatment groups in the head injury trials. In this report the authors examine the studies in detail and discuss the potential application of the data to future trial designs. Aeromedical crews offer an advanced level of practice and rapid transport to definitive care; however, their efficacy remains unproven. Previous studies have used relatively small sample sizes or have been unable to adequately control for the effect of other potentially influential variables. Here we explore the impact of aeromedical response in patients with moderate to severe traumatic brain injury.
                This was a retrospective analysis using our county trauma registry. All patients with head Abbreviated Injury Score of 3 or greater were included; interfacility transfers were excluded. The impact of aeromedical response was determined using logistic regression, adjusting for age, sex, mechanism, preadmission Glasgow Coma Scale score, head Abbreviated Injury Score, Injury Severity Score, and the presence of preadmission hypotension. Propensity scores were used to account for variability in selection of patients to undergo air versus ground transport. Patients with moderate and severe traumatic brain injury, as defined by head Abbreviated Injury Score and Glasgow Coma Scale score, were compared. Finally, aeromedical patients undergoing field intubation were compared with ground patients undergoing emergency department (ED) intubation.
                A total of 10,314 patients meeting all inclusion and exclusion criteria and with complete data sets were identified and included 3,017 transported by aeromedical crews. Overall mortality was 25% in the air- and ground-transported cohorts, but outcomes were significantly better for the aeromedical patients when adjusted for age, sex, mechanism of injury, hypotension, Glasgow Coma Scale score, head Abbreviated Injury Score, and Injury Severity Score (adjusted odds ratio [OR] 1.90; 95% confidence interval [CI] 1.60 to 2.25; P<.0001). Good outcomes (discharge to home, jail, psychiatric facility, rehabilitation, or leaving against medical advice) were also higher in aeromedical patients (adjusted OR 1.36; 95% CI 1.18 to 1.58; P<.0001). The primary benefit appeared to be in more severely injured patients, as reflected by head Abbreviated Injury Score and Glasgow Coma Scale score. Improved survival was also observed for air-transported patients intubated in the field versus ground-transported patients given emergency intubation in the ED (adjusted OR 1.42; 95% CI 1.13 to 1.78; P<.001).
                Here we analyze a large database of patients with moderate to severe traumatic brain injury. Aeromedical response appears to result in improved outcomes after adjustment for multiple influential factors in patients with moderate to severe traumatic brain injury. In addition, out-of-hospital intubation among air-transported patients resulted in better outcomes than ED intubation among ground-transported patients. Patients with more severe injuries appeared to derive the greatest benefit from aeromedical transport. To assess the current morbidity and mortality of motorcycle trauma in the state of Illinois and, specifically, to assess the incidence and cost of head injury to motorcycle crash patients according to their helmet use.
                Retrospective, cross-sectional examination of the Illinois Department of Public Health Trauma Registry, for which data are available from July 1, 1991, through December 31, 1992. Data are collected from all hospitals designated as Level I or Level II trauma centers in Illinois.
                All patients involved in motorcycle crashes and subsequently taken to a Level I or Level II trauma center in Illinois and entered into the trauma registry during the period studied.
                Head injury, spinal injury, helmet use, demographic data, hospital charges, days in ICU, and source of payment were selected as outcome measures. During the 18-month study period, 1,231 motorcycle trauma patients were entered into the trauma registry. Eighteen percent were helmeted and 56.0% were nonhelmeted. In 26.0% the helmet status at the time of the crash was unknown. Thirty percent of the helmeted patients sustained head injury and 4% sustained spinal or vertebral injury, compared with 51% and 8%, respectively, for nonhelmeted patients. Nonhelmeted patients were significantly more likely to sustain severe (Abbreviated Injury Score [AIS], 3 or more) or critical (AIS, 5 or more) head injury. Patients with these serious head injuries incurred almost three times the hospital charges and used a disproportionately larger share of ICU days than those with mild or no head injuries. There was a trend toward greater use of public funds or self-pay status (no insurance) for payment of hospital charges in nonhelmeted patients.
                Motorcycle helmet nonuse was associated with an increased incidence of serious head injury. Motorcycle trauma patients with severe or critical head injuries used a significantly greater proportion of ICU days and hospital charges than those with mild or no head injuries. Motor-vehicle incidents in Taiwan are a major cause of head injuries. Our objective was to analyze the characteristics of head injuries caused by motor vehicle accidents in terms of the injured person's demographic characteristics, time and types of crash, injury severity on the abbreviated injury scale (AIS), medical cost and benefits of helmet protection. For this purpose we conducted an epidemiologic survey of 2451 consecutive victims of traffic accidents, coming to, or managed at, the emergency care department of a large Taipei metropolitan hospital in 1990. The results showed that the most common cause of head injury in traffic accidents was a motorcycle incident. Motorcycle accident injured patients were generally young males, laborers or students. Most head injuries occurred between 16:00 and 23:00, and peaking at 21:00 in a day. Forty-three points four percent of patients were admitted, major head injury fatalities occurred within one week of the collision. The elderly or patients with high AIS comprised most nonsurvivors. According to our data, helmet usage was about 14% overall. Helmetless young riders were numerous among the total victims. A significant difference was noted in the severity of injury of helmeted users of motorcycles, compared with those who wore no helmet. As expected, patients who did not wear a helmet had a greater AIS average and higher rate of fatality. Forty-one of the 42 fatalities were patients who had been riding on motorcycles without helmets. Helmets provide adequate protection and reduce severity of injury, and medical cost for motorcycle collisions. Many studies have reported that helmet use by motorcycle riders significantly decreases their risk of head injury, death, and disability in the event of a crash. However, these studies have not controlled for crash severity and thus do not conclusively show the value of helmet use by motorcycle riders. Using data from a statewide trauma registry, the present study examines the association of helmet use with various outcomes of motorcycle crashes, controlling for overall crash severity as measured by a modified Injury Severity Score. The results show that in crashes where the overall degree of injury was comparable, the risk of head injury in hospitalized motorcyclists was nearly twice as high for unhelmeted riders as it was for helmeted riders, thus confirming the protective effects of helmet use. However, there were no significant differences in various measurements of resource utilization, including days in hospital, hospital charges, and need for post-hospital rehabilitation. A higher incidence of extremity injuries among the helmeted riders may account for their failure to demonstrate consistently lower resource utilization, despite lower rates of head injury.
The data available are inadequate to assess any potential benefit or harm that might result from hyperventilation in severe head injury. Randomised controlled trials to assess the effectiveness of hyperventilation therapy following severe head injury are needed.