Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 15
- 主要终点
- Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score
研究概览
简要总结
The purpose of this study is to learn more about how participants heal from acute spinal cord injury.
详细描述
In this study, the investigators will learn about the effect of targeted blood pressure management (TPM) on participants healing from acute spinal cord injury.
The investigators want to learn:
The effect of two types of TPM on long term motor and sensory outcomes. The effect of two types of TPM on long-term pain and functional independence outcomes.
How safe TPM is for participants.
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
- 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
- 否
入选标准
- •Acute traumatic spinal cord injury (SCI) involving neurological levels as defined by the ASIA neurological examination between C0 and T8 (tetraplegia) and resulting in new onset neurological deficits consistent with an ASIA motor assessment of level A, B or C.
- •Subject is 18 years of age or older.
排除标准
- •Penetrating SCI injury.
- •Isolated cauda equina syndrome or injury at bony level Th9 or below.
- •Pre-existing motor deficit secondary to chronic myelopathy.
- •History of demyelinating disease or central nervous system autoimmune disorder.
- •History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D).
- •Acute, evolving or recent (30 days) myocardial infarction.
- •Chronic renal failure requiring dialysis.
- •Suspected or confirmed pregnancy.
- •Severe terminal disease with life expectancy less than 6 months.
- •Severe traumatic brain injury at presentation (GCS ≤8) with confirmation of injury on brain imaging.
- •A condition that would preclude the performance of an accurate neurological exam due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation.
- •Non-English or Non-Spanish Speaking.
- •Refusal of consent.
研究组 & 干预措施
Augmented Blood Pressure
Subjects will have their blood pressure kept in a higher range.
干预措施: Augmented Blood Pressure (Other)
Conventional Blood Pressure
Subjects will have their blood pressure kept in a normal range.
结局指标
主要结局
Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score
时间窗: 6 months after spinal cord injury
Change from baseline in ASIA Upper Extremities Motor Score (UEMS), comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The UEMS score ranges from 0 to 50, with 50 indicating no deficits.
Change From Baseline in American Spinal Injury (ASIA) Lower Extremities Motor Score
时间窗: 6 months after spinal cord injury
Change from baseline in ASIA Lower Extremities Motor Score (LEMS), comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The LEMS score ranges from 0 to 50, with 50 indicating no deficits.
Change From Baseline in American Spinal Injury Association (ASIA) Sensory Score
时间窗: 6 months after spinal cord injury
Change from baseline in ASIA Sensory Score, comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The total Sensory Score adds light touch points (max 112) and pin prick points (max 112). The total score ranges from 0 to 224, with higher scores indicating better neurological outcomes.
Change From Baseline in American Spinal Injury Association (ASIA) Sensory Score
时间窗: 6 months after spinal cord injury
Change from baseline in ASIA Sensory Score, comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The total Sensory Score adds light touch points (max 112) and pin prick points (max 112). The total score ranges from 0 to 224, with higher scores indicating better neurological outcomes.
Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score
时间窗: 6 months after spinal cord injury
Change from baseline in ASIA Upper Extremities Motor Score (UEMS), comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The UEMS score ranges from 0 to 50, with 50 indicating no deficits.
Change From Baseline in American Spinal Injury (ASIA) Lower Extremities Motor Score
时间窗: 6 months after spinal cord injury
Change from baseline in ASIA Lower Extremities Motor Score (LEMS), comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The LEMS score ranges from 0 to 50, with 50 indicating no deficits.
次要结局
- International Spinal Cord Injury Quality of Life (ISCIQoL) Basic Data Set(6 months after spinal cord injury)
- Spinal Cord Independence Measure III Score(6 months after spinal cord injury)
- Pain Scores on the International Spinal Cord Injury Basic Pain Data Set(6 months after spinal cord injury)
- Pain Scores on the International Spinal Cord Injury Basic Pain Data Set(6 months after spinal cord injury)
- Spinal Cord Independence Measure III Score(6 months after spinal cord injury)
- International Spinal Cord Injury Quality of Life (ISCIQoL) Basic Data Set(6 months after spinal cord injury)
研究者
Miriam Treggiari
Professor
Oregon Health and Science University