Contrast-Enhanced Ultrasound Biomarker for Prognostication and Guidance of Surgical Treatment in Acute Traumatic Spinal Cord Injury
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Outcomes of all subjects who received contrast enhanced ultrasound imaging, to check perfusion during the surgical repair of an acute spinal cord injury.
研究概览
简要总结
Patients with traumatic spinal cord injury (tSCI) often suffer from spinal cord swelling inside the thecal sac, which contains the spinal cord and surrounding fluid, leading to increased pressure on the spinal cord tissue and decreased spinal cord blood flow at the site of injury. The combination of increased pressure and decreased blood flow causes vascular hypoperfusion of the spinal cord and exacerbates the severity of injury. This is also referred to as secondary injury. Thus, knowledge of spinal cord hypoperfusion would allow the treating physician to optimize the hemodynamic condition of the patient with acute spinal cord injury and potentially improve functional outcomes.
详细描述
The investigators plan to use contrast-enhanced ultrasound (CEUS) to determine a decrease in the blood flow in the spinal cord at the site of injury, during the routine surgery that these patients require to decompress and stabilize their injured spine. This may help the investigators to determine the efficacy of certain treatments in improving blood flow and patients suffering from traumatic spinal cord injury.
Patients presenting to Harborview Medical Center with a diagnosis of traumatic spinal cord injury will be screened for participation. Many of these patients require emergent or urgent surgery for decompression of the spinal cord and stabilization of the spine.
The patient will be taken to the operating room as per routine. After completion of the key elements of surgery, namely posterior decompression, and stabilization of the cervical or thoracic spinal cord, CEUS will be performed. Importantly, the proposed trial does not prolong the time before surgical decompression and stabilization are accomplished. Moreover, it does not increase the invasiveness of the procedure as it is collected at the final stage of the routine procedure. A hand-held intraoperative ultrasound probe will be used to collect sagittal images of the spinal cord centered above the spinal cord injury. A bolus IV injection of the contrast agent will be given. Continuous imaging will be obtained to record contrast inflow and washout.
Post-operatively, the participant will receive routine MRI imaging within one week (health status permitting) and one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age minimum
- •Acute spinal cord injury fpr less than 24 hours
- •Injury ranging from mild spinal cord injury where motor function is preserved (AIS A) to complete injury where there is no motor or sensory function below the leel of the injury (AIS D)
- •Medically stable to undergo routine dorsal decompression, spinal realignment
- •and stabilizing with segmental instrumentation
排除标准
- •Younger than 18 years old
- •Neurological lower extremity exam missing or intact
- •Traumatic head injury with a Glasgow score of 11 or lower
- •Cord injury level caudal to T10 (thoracic spine level 10)
- •A known sensitivity to lipid microsphere or its components, such as polyethylene glycol (PEG)
- •A history of anaphylactoid reactions from ultrasound enhancing agents
- •A known history of cardiopulmonary conditions
- •Cardiac shunt
研究组 & 干预措施
Contrast-enhanced ultrasound in traumatic spinal cord injury
A bolus IV injection of Perflutren lipid contrast agent will be given. Continuous imaging will be obtained.
干预措施: Perflutren lipid (Drug)
结局指标
主要结局
Outcomes of all subjects who received contrast enhanced ultrasound imaging, to check perfusion during the surgical repair of an acute spinal cord injury.
时间窗: Two years
Knowledge of spinal cord hypoperfusion will allow the physician to optimize the hemodynamic condition of acute spinal cord injury and potentially improve outcomes. The investigators plan to use contrast-enhanced ultrasound to determine decreased blood flow in the spinal cord at the site of injury, during the routine surgery that these patients require to decompress and stabilize their injured spine.
次要结局
- Determine the prognostic capacity of CEUS biomarker for acute tSCI and surgical outcomes/recovery in spine injury/surgery.(Two years)
研究者
Christoph Hofstetter
Associate Professor: Neurological Surgery
University of Washington