Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Hemorrhage Quantification 2
研究概览
简要总结
The study is designed to determine whether hemorrhage within the injured spinal cord is influenced by mean arterial pressure (MAP) augmentation with vasopressors and by venous thromboembolism (VTE) prophylaxis with anticoagulants in the first two weeks following a traumatic spinal cord injury (tSCI).
详细描述
This will be a single-center prospective observational study of patients with an acute cervical traumatic spinal cord injury
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute tSCI injury involving bony spinal levels between C0 and T1
- •Baseline Asia Impairment Scale (AIS) grade of A, B, or C
- •Admission to study site within 24 hours of injury
- •Male or female age 19 or older
- •Able and willing to provide informed consent
排除标准
- •Pathological fracture due to metabolic condition or neoplasia
- •Spinal cord injury due to infection
- •Presence of pacemaker, aneurysm clip or other device which is a contraindication to MRI
- •BMI > 40 and unable to fit within the MRI scanner
- •Multiple life threatening injuries (ISS >16) that make transport to MRI not in the patient's best interest
- •Any condition that, at the time of admission, prevents a complete ISNCSCI assessment from being performed
结局指标
主要结局
Hemorrhage Quantification 2
时间窗: Serial MRI assessments: Injury to 2 weeks post injury
Vertical length of hematoma and vertical length of cord edema
Hemorrhage Quantification 1
时间窗: Serial MRI assessments: Injury to 2 weeks post injury
Area of hematoma
Hemorrhage Quantification 4
时间窗: Serial MRI assessments: Injury to 2 weeks post injury
Vertical length of cord edema rostral to maximum compression and vertical length of cord edema caudal to maximum compression.
Hemorrhage Quantification 3
时间窗: Serial MRI assessments: Injury to 2 weeks post injury
The point of maximum cord compression vertebral level and anatomic point of maximum cord compression vertebral sublevel
次要结局
- Hemodynamic Management Assessment 1(Injury to 2 weeks post injury)
- Hemodynamic Management Assessment 2(Injury to 2 weeks post injury)
研究者
Brian Kwon
Principal Investigator
University of British Columbia