Guidelines for the management of acute cervical spine and spinal cord injuries: 2013 update.
TL;DR: The purpose of this article is to provide an overview of the changes in the recommendations as a result of new evidence or broadened scope.
Abstract: In 2002, an author group selected and sponsored by the Joint Section on Spine and Peripheral Nerves of the American Association of Neurological Surgeons and Congress of Neurological Surgeons published the first evidence-based guidelines for the management of patients with acute cervical spinal cord injuries (SCIs). In the spirit of keeping up with changes in information available in the medical literature that might provide more contemporary and more robust medical evidence, another author group was recruited to revise and update the guidelines. The review process has been completed and is published and can be once again found as a supplement to Neurosurgery. The purpose of this article is to provide an overview of the changes in the recommendations as a result of new evidence or broadened scope.
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01 Apr 2018
TL;DR: The treatment of traumatic spinal cord injury remains supportive, and prognosis is still poor for patients who are severely affected, and future efforts would be most useful if focused on injury prevention and the development of effective neuroregenerative therapies.
Abstract: Trauma to the spinal cord can have devastating functional consequences, and treatments are limited once the injury is fully established. Therefore, any patient with possible acute neck trauma should have the neck immobilized in the field until the injury can be excluded by appropriate imaging. Once in the Emergency Department, a focused but detailed examination and CT scanning of the spine can reliably determine if spinal cord injury has occurred, though its severity may be confounded by the initial spinal shock. Severe spinal cord injury is often associated with circulatory shock (neurogenic or hypovolemic), and this must be immediately corrected to prevent secondary injury from spinal cord hypoperfusion. When indicated, definite surgical stabilization should be pursued within the first 1–2 days. Prognosis should be approached cautiously during the early phase. This chapter will provide a practical overview of the acute evaluation and medical management of traumatic spinal cord injury.
357 citations
TL;DR: A large number of trials in the field of spinal cord injury have been conducted, but with few proven gains for patients, and this review reveals several shortcomings in trial design and makes several recommendations for improvement.
Abstract: OBJECTIVE: To provide a comprehensive review of the treatment trials in the field of spinal cord injury, emphasizing what has been learned about the effectiveness of the agents and strategies tested and the quality of the methodology. The review aims to provide useful information for the improvement of future trials. The review audience includes practitioners, researchers, and consumers. METHODS: All publications describing organized trials since the 1960s were analyzed in detail, emphasizing randomized, prospective controlled trials and published Phase I and II trials. Trials were categorized into neuroprotection, surgery, regeneration, and rehabilitation trials. Special attention was paid to design, outcome measures, and case selection. RESULTS: There are 10 randomized prospective control trials in the acute phase that have provided much useful information. Current neurological grading systems are greatly improved, but still have significant shortcomings, and independent, trained, and blinded examiners are mandatory. Other trial designs should be considered, especially those using adaptive randomization. Only methylprednisolone and thyrotropin-releasing hormone have been shown to be effective, but the results of the former are controversial, and studies involving the latter involved too few patients. None of the surgical trials has proven effectiveness. Currently, a multitude of cell-based Phase I trials in several countries are attracting large numbers of patients, but such treatments are unproven in effectiveness and may cause harm. Only a small number are being conducted in a randomized or blinded format. Several consortia have committed to a promise to improve the conduct of trials. CONCLUSION: A large number of trials in the field of spinal cord injury have been conducted, but with few proven gains for patients. This review reveals several shortcomings in trial design and makes several recommendations for improvement.
279 citations
TL;DR: This chapter will focus on the clinical issues related to abnormal cardiovascular control in individuals with spinal cord injury, which include neurogenic shock, autonomic dysreflexia and orthostatic hypotension.
Abstract: On a daily basis, individuals with cervical and upper thoracic spinal cord injury face the challenge of managing their unstable blood pressure, which frequently results in persistent hypotension and/or episodes of uncontrolled hypertension. This chapter will focus on the clinical issues related to abnormal cardiovascular control in individuals with spinal cord injury, which include neurogenic shock, autonomic dysreflexia and orthostatic hypotension. Blood pressure control depends upon tonic activation of sympathetic preganglionic neurons by descending input from the supraspinal structures (Calaresu and Yardley, 1988). Following spinal cord injury, these pathways are disrupted, and thus spinal circuits are solely responsible for the generation of sympathetic activity (Osborn et al., 1989; Maiorov et al., 1997). This results in a variety of cardiovascular abnormalities that have been well documented in human studies, as well as in animal models (Osborn et al., 1990; Mathias and Frankel, 1992a, b; Krassioukov and Weaver, 1995; Maiorov et al., 1997, 1998; Teasell et al., 2000). However, the recognition and management of these cardiovascular dysfunctions following spinal cord injury represent challenging clinical issues. Moreover, cardiovascular disorders in the acute and chronic stages of spinal cord injury are among the most common causes of death in individuals with spinal cord injury (DeVivo et al., 1999).
256 citations
TL;DR: The observed motor recovery in this open-label trial suggests that BA-210 may increase neurological recovery after complete SCI, and further clinical trials with Cethrin in SCI patients are planned, to establish evidence of efficacy.
Abstract: Multiple lines of evidence have validated the Rho pathway as important in controlling the neuronal response to growth inhibitory proteins after central nervous system (CNS) injury. A drug called BA-210 (trademarked as Cethrin®) blocks activation of Rho and has shown promise in pre-clinical animal studies in being used to treat spinal cord injury (SCI). This is a report of a Phase I/IIa clinical study designed to test the safety and tolerability of the drug, and the neurological status of patients following the administration of a single dose of BA-210 applied during surgery following acute SCI. Patients with thoracic (T2-T12) or cervical (C4-T1) SCI were sequentially recruited for this dose-ranging (0.3 mg to 9 mg Cethrin), multi-center study of 48 patients with complete American Spinal Injury Association assessment (ASIA) A. Vital signs; clinical laboratory tests; computed tomography (CT) scans of the spine, head, and abdomen; magnetic resonance imaging (MRI) of the spine, and ASIA assessment we...
230 citations
01 Jan 2005
TL;DR: In this paper, the authors suggest that the early post-injury period may present a unique opportunity for meaningful intervention, based on results obtained in animal studies that demonstrate the potential for improving functional outcome when surgical intervention is performed within a few hours following experimental spinal cord injury.
Abstract: U Appropriate timing for surgical intervention following destabilizing cervical or thoracic spine trauma remains controversial. Clinical investigators have failed to provide convincing evidence that the timing of surgery significantly affects neurological outcome in most situations. Nevertheless, early surgical stabilization of the injured spine has been shown to provide significant nonneurological benefits such as more rapid patient mobilization, facilitation of treating associated injuries, reduction in rates of pulmonary and pressure sore complications, reduction in duration of intensive care unit and hospital stays, and a decrease in overall medical costs. The findings of basic science studies have improved our understanding of the molecular and cellular events surrounding initial and secondary spinal cord injury (SCI), and analysis of these findings suggests that the early postinjury period may present a unique opportunity for meaningful intervention. This possibility has been supported by results obtained in animal studies that demonstrate the potential for improving functional outcome when surgical intervention is performed within a few hours following experimental SCI. Despite the absence of significant neurological recovery in most clinical studies, the results of most recent clinical studies strongly support the overall clinical benefits of early surgical intervention, particularly in the setting of unstable thoracic spinal column injury with associated SCI. Based on the best available scientific and clinical evidence, the authors report that it is therefore recommended that surgical stabilization be performed in as timely a fashion as possible, particularly for unstable thoracic spine trauma, within the constraints of the patient’s overall medical condition and availability of appropriate resources.
182 citations
References
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TL;DR: Patients with acute spinal cord injury who receive methylprednisolone within 3 hours of injury should be maintained on the treatment regimen for 24 hours, and patients treated with tirilazad for 48 hours showed motor recovery rates equivalent to patients who received methylpredisonsolone for 24Hours.
Abstract: Objective. —To compare the efficacy of methylprednisolone administered for 24 hours with methyprednisolone administered for 48 hours or tirilazad mesylate administered for 48 hours in patients with acute spinal cord injury. Design. —Double-blind, randomized clinical trial. Setting. —Sixteen acute spinal cord injury centers in North America. Patients. —A total of 499 patients with acute spinal cord injury diagnosed in National Acute Spinal Cord Injury Study (NASCIS) centers within 8 hours of injury. Intervention. —All patients received an intravenous bolus of methylprednisolone (30 mg/kg) before randomization. Patients in the 24-hour regimen group (n=166) received a methylprednisolone infusion of 5.4 mg/kg per hour for 24 hours, those in the 48-hour regimen group (n=167) received a methylprednisolone infusion of 5.4 mg/kg per hour for 48 hours, and those in the tirilazad group (n=166) received a 2.5 mg/kg bolus infusion of tirilazad mesylate every 6 hours for 48 hours. Main Outcome Measures. —Motor function change between initial presentation and at 6 weeks and 6 months after injury, and change in Functional Independence Measure (FIM) assessed at 6 weeks and 6 months. Results. —Compared with patients treated with methylprednisolone for 24 hours, those treated with methylprednisolone for 48 hours showed improved motor recovery at 6 weeks (P=.09) and 6 months (P=.07) after injury. The effect of the 48-hour methylprednisolone regimen was significant at 6 weeks (P=.04) and 6 months (P=.01) among patients whose therapy was initiated 3 to 8 hours after injury. Patients who received the 48-hour regimen and who started treatment at 3 to 8 hours were more likely to improve 1 full neurologic grade (P=.03) at 6 months, to show more improvement in 6-month FIM (P=.08), and to have more severe sepsis and severe pneumonia than patients in the 24-hour methylprednisolone group and the tirilazad group, but other complications and mortality (P=.97) were similar. Patients treated with tirilazad for 48 hours showed motor recovery rates equivalent to patients who received methylprednisolone for 24 hours. Conclusions. —Patients with acute spinal cord injury who receive methylprednisolone within 3 hours of injury should be maintained on the treatment regimen for 24 hours. When methylprednisolone is initiated 3 to 8 hours after injury, patients should be maintained on steroid therapy for 48 hours.
1,277 citations
TL;DR: It is concluded that in patients with acute spinal-cord injury, treatment with methylprednisolone in the dose used in this study improves neurologic recovery when the medication is given in the first eight hours.
Abstract: Studies in animals indicate that methylprednisolone and naloxone are both potentially beneficial in acute spinal-cord injury, but whether any treatment is clinically effective remains uncertain. We evaluated the efficacy and safety of methylprednisolone and naloxone in a multicenter randomized, double-blind, placebo-controlled trial in patients with acute spinal-cord injury, 95 percent of whom were treated within 14 hours of injury. Methylprednisolone was given to 162 patients as a bolus of 30 mg per kilogram of body weight, followed by infusion at 5.4 mg per kilogram per hour for 23 hours. Naloxone was given to 154 patients as a bolus of 5.4 mg per kilogram, followed by infusion at 4.0 mg per kilogram per hour for 23 hours. Placebos were given to 171 patients by bolus and infusion. Motor and sensory functions were assessed by systematic neurological examination on admission and six weeks and six months after injury. After six months the patients who were treated with methylprednisolone within eight hours of their injury had significant improvement as compared with those given placebo in motor function (neurologic change scores of 16.0 and 11.2, respectively; P = 0.03) and sensation to pinprick (change scores of 11.4 and 6.6; P = 0.02) and touch (change scores, 8.9 and 4.3; P = 0.03). Benefit from methylprednisolone was seen in patients whose injuries were initially evaluated as neurologically complete, as well as in those believed to have incomplete lesions. The patients treated with naloxone, or with methylprednisolone more than eight hours after their injury, did not differ in their neurologic outcomes from those given placebo. Mortality and major morbidity were similar in all three groups. We conclude that in patients with acute spinal-cord injury, treatment with methylprednisolone in the dose used in this study improves neurologic recovery when the medication is given in the first eight hours. We also conclude that treatment with naloxone in the dose used in this study does not improve neurologic recovery after acute spinal-cord injury.
942 citations
TL;DR: Decompression prior to 24 hours after SCI can be performed safely and is associated with improved neurologic outcome, defined as at least a 2 grade AIS improvement at 6 months follow-up.
Abstract: Background
There is convincing preclinical evidence that early decompression in the setting of spinal cord injury (SCI) improves neurologic outcomes. However, the effect of early surgical decompression in patients with acute SCI remains uncertain. Our objective was to evaluate the relative effectiveness of early (<24 hours after injury) versus late (≥24 hours after injury) decompressive surgery after traumatic cervical SCI.
839 citations
"Guidelines for the management of ac..." refers background in this paper
...Although designed as a prospective, nonrandomized comparative study (Class II), methodological flaws downgrade it to Class III evidence, rendering it unhelpful for establishing quality and certainty in the case of acute surgical intervention in SCI.(26) Systemic hypothermia has been studied in animal models of SCI but only anecdotally in humans by way of a single Class II study also published after the current guidelines went to press....
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...Although designed as a prospective, nonrandomized comparative study (Class II), methodological flaws downgrade it to Class III evidence, rendering it unhelpful for establishing quality and certainty in the case of acute surgical intervention in SCI.26 Systemic hypothermia has been studied in animal models of SCI but only anecdotally in humans by way of a single Class II study also published after the current guidelines went to press....
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...There is no Class I or Class II medical evidence supporting the clinical benefit of methylprednisolone in the treatment of acute SCI. Scattered reports of Class III evidence claim inconsistent effects likely related to random chance or selection bias....
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...Functional magnetic resonance imaging may potentially contribute to SCI research, but to date, there are no clinical studies that establish its usefulness in human SCI....
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TL;DR: The 1-year follow-up data of a multicenter randomized controlled trial of methylprednisolone treatment for acute spinal cord injury are reported and compared with placebo results as discussed by the authors.
Abstract: The 1-year follow-up data of a multicenter randomized controlled trial of methylprednisolone (30 mg/kg bolus and 5.4 mg/kg/hr for 23 hours) or naloxone (5.4 mg/kg bolus and 4.0 mg/kg/hr for 23 hours) treatment for acute spinal cord injury are reported and compared with placebo results. In patients treated with methylprednisolone within 8 hours of injury, increased recovery of neurological function was seen at 6 weeks and at 6 months and continued to be observed 1 year after injury. For motor function, this difference was statistically significant (p = 0.030), and was found in patients with total sensory and motor loss in the emergency room (p = 0.019) and in those with some preservation of motor and sensory function (p = 0.024). Naloxone-treated patients did not show significantly greater recovery. Patients treated after 8 hours of injury recovered less motor function if receiving methylprednisolone (p = 0.08) or naloxone (p = 0.10) as compared with those given placebo. Complication and mortality rates were similar in either group of treated patients as compared with the placebo group. The authors conclude that treatment with the study dose of methylprednisolone is indicated for acute spinal cord trauma, but only if it can be started within 8 hours of injury.
686 citations
TL;DR: No significant difference was observed in neurological recovery of motor function, pinprick response, or touch sensation 1 year after injury between the two treatment groups, after adjustment for other potentially confounding factors.
Abstract: A multi-center double-blind randomized clinical trial was conducted by the National Acute Spinal Cord Injury Study Group to examine the efficacy of high-dose methylprednisolone (1000-mg bolus and 1000 mg daily thereafter for 10 days) compared with that of a standard dose (100-mg bolus and 100 mg daily for 10 days) No significant difference was observed in neurological recovery of motor function, pinprick response, or touch sensation 1 year after injury between the two treatment groups, after adjustment for other potentially confounding factors Analyses that specifically took into account the patients' total steroid dose and relative weight confirmed the lack of a steroid treatment effect The case fatality rate was 107% during the 1st year after injury, and this was not associated with the steroid treatment protocol or the patient's gender Deaths did occur significantly more frequently among patients who were completely (153%) and partially (86%) plegic than among those who were paretic (25%, p = 00005), and among patients aged 50 years or older (386%, p = 00001)
296 citations