Evaluation of the Benefits of Decompressive Craniectomy for Severe Traumatic Brain Injury in Children With Refractory Intracranial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- functional neurological status of the patients at 2 years
研究概览
简要总结
Severe traumatic brain injury (TBI) is the leading cause of mortality and severe disability in the pediatric population. The prognosis of these patients depends on the severity of the initial lesions but also on the effectiveness of the therapies used to prevent or at least limit secondary lesions mainly intracranial hypertension (HTIC).
The medical therapeutic strategy for the control of HTIC in children with TBI is well codified: starting with hyperosmolar therapy, then hyperventilation and ultimately the use of barbiturates to deepen sedation. However, these therapies are not devoid of adverse effects (hypernatremia, cerebral hypoxemia, systemic vasodilation) and, for some, their efficacy is diminished over time. When these treatments are insufficient to lower intracranial pressure (ICP), decompressive craniectomy is proposed. Decompressive craniectomy is used in a well-coded manner in malignant ischemic stroke in adults.
In TBI, to date, there are two randomized studies in adults and one in children but with a small number of patients, evaluating the benefit of decompressive craniectomy. None of them showed significantly superiority of the surgery compared to the maximal medication treatment on the functional prognosis in the medium term.
However, these studies have many biases, including a significant cross-over from the conservative treatment group to the surgery arm.
Nevertheless, the pediatric literature on the subject seems to yield better results on neurological prognosis in the long term. There are guidelines on the medical management of childhood TBI published by the National Institute of Health in 2012, which emphasize the need for controlled and randomized studies to define the place of decompressive craniectomy in children. That is why the investigators are proposing this national multicentre study.
详细描述
Severe Traumatic Brain Injury (STBI) constitutes the foremost cause of death and severe disability in the pediatric population. The severity of cranial trauma is evaluated by the Glasgow score. STBI corresponds with an initial Glasgow score of ≤ 8. The prognosis for patients with cranial trauma depends on the severity of the initial lesions, as well as the efficacy of the therapies applied to prevent, or at least limit, secondary lesions that are linked primarily to intracranial hypertension (ICH). Therapeutic treatments are based on the guidelines set by the Brain Trauma Foundation. These treatments mainly comprise heavy sedation known as "neurosedation" (maintaining hemodynamics, normothermia, hyperventilation, hyperosmolar therapy, and the administration of barbiturates).
When these therapies are not sufficiently effective, refractory ICH occurs, which is defined by a maximal value of intracranial pressure (ICP) as well as a minimal value for the Cerebral Perfusion Pressure (CPP), which corresponds to the Arterial Pressure (AP) minus the ICP (CPP=AP-ICP). Decompressive craniectomy (DC) may be used to treat refractory ICH. DC consists of removing part of the skull, which increase the "intracranial volume", thereby resulting in a decrease the ICP.
This surgical technique has been used systematically for several years to treat malignant ischemic stroke in adults. There have been three randomized studies to date of its use with STBI , of which only one was in regard to children. While decompressive craniectomy appears to decrease the ICP, no significant difference has been seen in adults in terms of the neurological outcomes when comparing patients who had an optimal medical management versus those who had this same treatment in conjunction with a decompressive craniectomy. Outcomes in children appear to be different, however, although the only randomized pediatric study had just 27 patients and the surgical technique that was used did not meet current standards. The other pediatric publications to date mostly involved series with limited numbers of cases and that hence do not allow conclusions to be drawn regarding the efficacy of craniectomy.
The latest guidelines underscore the need for controlled and randomized studies to establish the merits of decompressive craniectomy in children. This is why the investigators are proposing to undertake this study.
The main objective of this study is to compare decompressive craniectomy in association with an optimal medical management in children with Severe traumatic brain injury involving refractory intracranial hypertension, versus an optimal medical management only, in terms of the long-term (i.e. two year) functional neurological prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 18 years of age
- •Severe traumatic brain injury (initial Glasgow coma scale < 9)
- •Accidental trauma
- •Refractory intracranial hypertension: ICP > 20 mmHg over 30 minutes for children more than one year of age and ICP > 15 mmHg over 30 minutes for children of less than one year of age.
- •The patient must receive optimal medical management
- •Affiliation with a social security scheme
- •Signed informed consent is to be provided by the two holders of parental authority
排除标准
- •Inflicted cranial trauma (e.g. shaken baby syndrome)
- •Patients having an initial surgery for removal of an intracranial hemorrhagic collection of blood (e.g. a subdural hematoma, extradural hematoma, and intraparenchymal hematoma) for which the flap was not replaced.
- •Pregnant patient
结局指标
主要结局
functional neurological status of the patients at 2 years
时间窗: two years after surgery
Functional neurological status (equating with success of the treatment) will be measure by the Glasgow Outcomes Scale-Extended Pediatric version. Extended GOS (GOSE) provides detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category. the GOSE range from 1 to 8 (Upper Good Recovery to Death). A score from 3 defines satisfactory functional neurological status. This threshold is selected as it equates to a moderate level of disability, that is to say a child that is autonomous in regard to daily activities and that is able to attend school
次要结局
- Evaluation of the overall cognitive functioning(at 1 year and 2 years after inclusion)
- description of surgical parameters patients with successful craniectomy(at 2 years after craniectomy)
- Progression of the IntraCranial Pressure at 24 hours(24 hours after inclusion)
- functional neurological status of the patients at 1 years(1 year after inclusion)
- description of clinical parameters patients with successful craniectomy(at 2 years after craniectomy)
- description of radiological parameters patients with successful craniectomy(at 2 years after craniectomy)
- number of adverse events linked to surgery(from inclusion time to the end of patient participation, for about 2 years)
- Overall survival(at 3 months and 2 years post cranial trauma)
- Evaluation of quality of life(at 3 months, 1 years and 2 years)