跳至主要内容
临床试验/NCT01624545
NCT01624545已完成不适用

To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation - a Prospective, Randomized, Controlled Trial

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
368
试验地点
2
主要终点
modified Rankin Scale

研究概览

简要总结

Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These hematomas develop after minor head trauma and increase in size over weeks. Patients usually present with headaches, gait disturbances, language problems or confusion. The state of the art treatment of a symptomatic chronic subdural hematoma is to remove the hematoma by burr hole trepanation.

The optimal follow-up for operated patients remains controversial. Due to the known high rate of a second hematoma at the same place (usually within weeks), one strategy is to perform serial computer tomography scans in order to identify recurrent hematomas early. The radiologic evidence of a second hematoma often leads to reoperation, even if the patient has no, or just slight symptoms. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of new symptoms. Advocators of this strategy argue that a follow-up with routine CT scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a patient population marked by advanced age and fragility.

The aim of the current study is to evaluate the role of computer tomography scanning in the postoperative follow-up after removal of a chronic subdural hematoma. Participants of this study will be allocated by chance to one of two study groups: Patients allocated to group A will receive a computer tomography scan on day 2 and again on day 30 after surgery in addition to a clinical examination. Patients allocated to group B will be examined clinically on day 2 and day 30 without computer tomography. All patients will undergo a final clinical examination after 6 months. The study will recruit 400 patients.

详细描述

Background

Chronic subdural hematoma (CSH) is one of the most common intracranial bleedings in patients over 60 years of age and a frequently found neurosurgical entity. Age related brain atrophy leads to enlargement of the subarachnoid space, a space limited by the dura mater and the arachnoid membrane. Blood vessels that occupy this space are being stretched and may rupture after a minor head trauma. Although the resulting bleeding itself is often without noticeable consequence for the patient, the anatomical outcome may be serious as it enlarges the subdural space. The formation of new leaky capillary-like vessels and/or volume enhancing osmotic gradients lead to the enlargement of the subdural hematoma over weeks, filling the intracranial space and compressing the brain. Headaches, gait disturbances, language problems, hemiparesis and decreased consciousness are among the many presenting symptoms and tend to develop over days or weeks.

Computed tomography (CT) scan or magnetic resonance imaging (MRI) of the head typically reveals the blood accumulation in the subdural space. Standard treatment includes the evacuation of the subdural blood through burr holes (see below) under either local or general anesthesia. In cases when a hematoma clot cannot be evacuated through burr holes a small craniotomy is performed. CSH is feared for its high recurrence rate (between 9 and 27%) that mostly occurs within 3 months of the initial operation.

The optimal follow-up course for operated patients remains controversial. Due to the high rate of recurrences, one strategy is to perform serial CT scans in order to identify recurrent hematomas early. The radiologic evidence of a recurrent or significant persistent hematoma often leads to reoperation. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of persistent or new neurologic deficits. Advocators of this strategy argue that follow up with routine CT scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a patient population marked by advanced age and fragility.

However, even when neuroimaging is done routinely, no correlation has been observed between the radiologic evidence of a hematoma remnant and the reoperation rate. This observation has been reported by Mori and Maeda in a retrospective analysis of 500 patients. Some persistent hematoma is almost always seen after the surgical intervention and there seems to be a correlation between the re-expansion rate of the brain and the likelihood of hematoma recurrence. However, the correlation is weak and of little practical value for patient treatment. The high incidence of hematoma remnants in post-op imaging complicates the indication for re-operation of a recurrent CSH solely by imaging criteria. Since the presence and the amount of remnant hematoma after the operation is a poor predictor of future recurrent hematoma some clinicians refrain from postoperative CT scans and rely solely on neurological assessments. If patients become symptomatic, serial CT scans are performed and surgery is scheduled in cases of persistent, enlarging or new hematoma. The discrepancy in follow-up strategy reflects our current incomplete understanding of the pathophysiology of CSH and its recurrence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed chronic subdural hematoma by CT scan or MRI, operated within the last 48 hours
  • Age 18 years or older
  • Written informed consent from the patient to participate in the study
  • Exclusion Criteria
  • Moribund state of health prohibiting surgery
  • Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
  • Recurrent hematoma if the first surgery was performed before study start
  • CSH due to spontaneous spinal CSF fistula or meningeosis carcinomatosa
  • Pregnancy
  • Patient with Metastatic Disease and a high possibility to pass away in the next 6 month

排除标准

  • 未提供

结局指标

主要结局

modified Rankin Scale

时间窗: 6 months

次要结局

  • QLQ-C30(6 months)
  • Rate of reoperation(6 months)
  • NIHSS(6 months)
  • Influence of the size and radiological features of the hematoma on rate of recurrence(6 months)
  • Total length of hospitalisation(6 months)
  • Mini Mental Status(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验