New European Directive on clinical trials.
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Clinical Trials as Topic↗
Biomedical subjects
Franco Servadei
Publications and source records attributed to Franco Servadei.
Traumatic encephalocele related to orbital roof fractures: report of six cases and literature review.
BACKGROUND: Orbital roof fractures after blunt injury are rare. Traumatic encephaloceles in the orbital cavity are even rarer, with only 15 cases published to date. METHODS: The clinical, radiological, and surgical findings of 6 cases of traumatic encephalocele treated at our institution from June 1998 to January 2000 are presented. They are also compared with previously published series. RESULTS: In contrast to other published cases, 5 out of 6 patients in our series were adults. The most common cause of trauma was road traffic accident. Ecchymosis and preoperative exophthalmos/proptosis were frequent. In all of our patients a coronal CT scan (3 mm increments with bone windows) was obtained. It demonstrated the extension of the orbital roof fractures and a possible encephalocele in 4 cases. Associated frontal brain contusions were seen in 5 cases. An MRI was performed in 3 patients (and only in 2 previously published cases); it showed the extension of the brain herniation into the orbital cavity. Surgical treatment via a fronto-basal approach with evacuation of the contused herniated brain tissue and orbital roof reconstruction was performed. The outcome at 6 months was good recovery in five patients with one patient still in a persistent vegetative state. Postoperatively the ocular disturbances improved in 5 cases. A review of the other published cases confirmed recovery of normal ocular function in the vast majority of the cases. CONCLUSIONS: Whenever orbital roof fractures associated with frontal contusions are identified in an acute brain injured patient, an orbital encephalocele should be suspected. In our opinion MRI is the investigation of choice in such patients. If the encephalocele is confirmed, a surgical approach via the subfrontal route is indicated with resection of herniated contused brain tissue, dural closure, and orbital roof reconstruction. Good results in regard to the orbital symptoms (mainly exophthalmos) can be expected.
Adult↗
Traumatic intracerebellar hemorrhage: clinicoradiological analysis of 81 patients.
OBJECTIVE: We report 81 patients with a traumatic intracerebellar hemorrhagic contusion or hematoma managed between 1996 and 1998 at 13 Italian neurosurgical centers. METHODS: Each center provided data about patients' clinicoradiological findings, management, and outcomes, which were retrospectively reviewed. RESULTS: A poor result occurred in 36 patients (44.4%). Forty-five patients (55.6%) had favorable results. For the purpose of data analysis, patients were divided into two groups according to their admission Glasgow Coma Scale (GCS) scores. In Group 1 (39/81 cases; GCS score, > or =8), the outcome was favorable in 95% of cases. In Group 2 (42/81 cases; GCS score, <8), the outcome was poor in 81% of cases. Twenty-seven patients underwent posterior fossa surgery. Factors correlating with outcome were GCS score, status of the basal cisterns and the fourth ventricle, associated supratentorial traumatic lesions, mechanism of injury, and intracerebellar clot size. Multivariate analysis showed significant independent prognostic effect only for GCS score (P = 0.000) and the concomitant presence of supratentorial lesions (P = 0.0035). CONCLUSION: This study describes clinicoradiological findings and prognostic factors regarding traumatic cerebellar injury. A general consensus emerged from this analysis that a conservative approach can be considered a viable, safe treatment option for noncomatose patients with intracerebellar clots measuring less than or equal to 3 cm, except when associated with other extradural or subdural posterior fossa focal lesions. Also, a general consensus was reached that surgery should be recommended for all patients with clots larger than 3 cm. The pathogenesis, biomechanics, and optimal management criteria of these rare lesions are still unclear, and larger observational studies are necessary.
Adolescent↗
Traumatic subarachnoid hemorrhage: demographic and clinical study of 750 patients from the European brain injury consortium survey of head injuries.
OBJECTIVE: Previous reports identified the presence of traumatic subarachnoid hemorrhage (tSAH) on admission computed tomographic (CT) scans as an independent prognostic factor in worsening outcomes. The mechanism underlying the link between tSAH and prognosis has not been clarified. The aim of this study was to investigate the association between CT evidence of tSAH and outcomes after moderate or severe head injuries. METHODS: In a survey organized by the European Brain Injury Consortium, data on initial severity, treatment, and subsequent outcomes were prospectively collected for 1005 patients with moderate or severe head injuries who were admitted to one of the 67 European neurosurgical units during a 3-month period in 1995. The CT findings were classified according to the Traumatic Coma Data Bank classification system, and the presence or absence of tSAH was recorded separately in the initial CT scan forms. RESULTS: Complete data on early clinical features, CT findings, and outcomes at 6 months were available for 750 patients, of whom 41% exhibited evidence of tSAH on admission CT scans. There was a strong, highly statistically significant association between the presence of tSAH and poor outcomes. In fact, 41% of patients without tSAH achieved the level of good recovery, whereas only 15% of patients with tSAH achieved this outcome. Patients with tSAH were significantly older (median age, 43 yr; standard deviation, 21.1 yr) than those without tSAH (median age, 32 yr; standard deviation, 19.5 yr), and there was a significant tendency for patients with tSAH to exhibit lower Glasgow Coma Scale scores at the time of admission. A logistic regression analysis of favorable/unfavorable outcomes demonstrated that there was still a very strong association between tSAH and outcomes after simultaneous adjustment for age, Glasgow Coma Scale Motor Scores, and admission CT findings (odds ratio, 2.49; 95% confidence interval, 1.74-3.55; P < 0.001). Comparison of the time courses for 164 patients with early (within 14 d after injury) deaths demonstrated very similar patterns, with an early peak and a subsequent decline; there was no evidence of a delayed increase in mortality rates for either group of patients (with or without tSAH). CONCLUSION: These findings for an unselected series of patients confirm previous reports of the adverse prognostic significance of tSAH. The data support the view that death among patients with tSAH is related to the severity of the initial mechanical damage, rather than to the effects of delayed vasospasm and secondary ischemic brain damage.
Adult↗
Current recommendations for neurotrauma.
Diagnostic and monitoring procedures for patients with head injury are aimed at early detection of mass lesions and secondary insults. Our therapeutic approach is based on our understanding of pathophysiologic mechanisms that cause secondary brain damage, and includes evacuation of mass lesions and prevention of secondary insults. Basic research has greatly increased our knowledge of these pathophysiologic mechanisms and has prompted the development of many neuroprotective agents, targeted to selected mechanisms. Unfortunately, it has proved difficult to demonstrate the benefit of such agents in the overall population of head-injured patients. Clinical research has emphasized the importance of ischemia in head injury and has demonstrated the deleterious effect of secondary insults on outcome. Medical management of patients with head injury has consequently focused on prevention of secondary insults, treatment of raised intracranial pressure, and maintenance of adequate cerebral perfusion pressure. The introduction of new monitoring techniques in head-injured patients offers the possibilities of more targeted therapy in individual patients, in contrast to the current practice of a staircase approach to treatment of raised intracranial pressure.In the US, an evidence-based approach has resulted in the wide acceptance of general principles, but at the same time highlighted the lack of hard evidence for the use of many therapeutic modalities. Practical guidelines, developed and published by the European Brain Injury Consortium, are based on expert opinion and consensus. Surveys have shown considerable variation in monitoring techniques and treatment. There is still considerable need for further improvements, both from a medical scientific perspective and from an organizational aspect. Particularly relevant are early resuscitation and stabilization at the scene of the accident, the organization of emergency services, admission policy to the intensive care unit, and improved policy for early identification of patients with operable intracranial hematoma. Further dissemination and general acceptance of already published guidelines may be expected to significantly improve care in head injury.
Journal Article↗
Descriptive epidemiology of head injury in Romagna and Trentino. Comparison between two geographically different Italian regions.
We studied the occurrence of head injury in two different Italian regions: Romagna and Trentino. Both geographical areas attract large numbers of seasonal tourists. The study was carried out over 1 year (January 1, 1998 to December 31, 1998), prospectively in Romagna and retrospectively in Trentino because of their different head injury management protocols. The study was based on all admissions to hospital extracted by medical staff from the case records, and all cases were identified by the ICD-9 codes (ranges: 800.0-800.3, 801.0-801.3, 803.0-803.3, 850, 851.0-851.1, 852.0-852.1, 853.0-853.1, 854.0-854.1). The annual incidence of hospitalization for head injury was 314/100,000, 297 for Romagna and 332 for Trentino. The causes of head trauma and the type of injuries were similar to those reported in the international literature, and so were the characteristics of the population at risk. Romagna recorded a higher incidence of head injury among the elderly, probably due to the widespread use of bicycles without safety helmets. In Romagna, where neurosurgery departments exist, hospital mortality was low (8/100,000/year). Based on similar international literature findings, different prevention measures are suggested to reduce the occurrence and severity of head injury.
Accidents↗