Spinal Cord Injury
Conditions
Brief summary
The purpose of this study is to learn more about how participants heal from acute spinal cord injury.
Detailed description
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.
Interventions
OTHERAugmented Blood Pressure
Subjects will have their blood pressure kept in a higher range.
Sponsors
Oregon Health and Science University
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Subject is 18 years of age or older.
Exclusion criteria
1. Penetrating SCI injury. 2. Isolated cauda equina syndrome or injury at bony level Th9 or below. 3. Pre-existing motor deficit secondary to chronic myelopathy. 4. History of demyelinating disease or central nervous system autoimmune disorder. 5. 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). 6. Acute, evolving or recent (30 days) myocardial infarction. 7. Chronic renal failure requiring dialysis. 8. Suspected or confirmed pregnancy. 9. Severe terminal disease with life expectancy less than 6 months. 10. Severe traumatic brain injury at presentation (GCS ≤8) with confirmation of injury on brain imaging. 11. 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. 12. Non-English or Non-Spanish Speaking. 13. Refusal of consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Cord Independence Measure III Score | 6 months after spinal cord injury | Spinal Cord Independence Measure III (SCIM III). The total SCIM III Score ranges from 0 to 100 points, with 0 indicating complete dependence and 100 indicating complete independence. |
| Pain Scores on the International Spinal Cord Injury Basic Pain Data Set | 6 months after spinal cord injury | Pain Interference with daily activity on the International Spinal Cord Injury Basic Pain Data Set. Pain Interference Score ranges from 0 to 10, with higher scores indicating higher pain levels. |
| International Spinal Cord Injury Quality of Life (ISCIQoL) Basic Data Set | 6 months after spinal cord injury | The ISCIQoL Basic Data Set is a 3-item self-report tool of quality of life across three domains: 1. Satisfaction with life as a whole; 2. Satisfaction with physical health; 3. Satisfaction with psychological health. Each domain scores from 0 to 10, and the total score range (sum of the 3 domains) ranges from 0 to 30. Higher scores indicate better perceived quality of life. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMiriam Treggiari, MD, PhD, MPH
Oregon Health and Science University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Augmented Blood Pressure Subjects will have their blood pressure kept in a higher range. | 46 |
| Conventional Blood Pressure Subjects will have their blood pressure kept in a normal range. | 46 |
| Total | 92 |
Baseline characteristics
| Characteristic | Conventional Blood Pressure | Total | Augmented Blood Pressure |
|---|---|---|---|
| Age, Continuous | 54.0 years STANDARD_DEVIATION 17.9 | 53.8 years STANDARD_DEVIATION 17.7 | 53.6 years STANDARD_DEVIATION 17.8 |
| Baseline American Spinal Injury Association (ASIA) Score Lower Extremities Motor Score | 6.1 Score STANDARD_DEVIATION 12.2 | 6.5 Score STANDARD_DEVIATION 12.8 | 6.9 Score STANDARD_DEVIATION 13.6 |
| Baseline American Spinal Injury Association (ASIA) Score Total Sensory Score | 77.3 Score STANDARD_DEVIATION 44.2 | 82.7 Score STANDARD_DEVIATION 49.7 | 87.8 Score STANDARD_DEVIATION 54.4 |
| Baseline American Spinal Injury Association (ASIA) Score Upper Extremities Motor Score | 23.0 Score STANDARD_DEVIATION 17.8 | 19.2 Score STANDARD_DEVIATION 15.9 | 17.1 Score STANDARD_DEVIATION 13.4 |
| Race/Ethnicity, Customized Hispanic | 5 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Male | 38 Participants | 76 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 46 | 7 / 46 |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 12 / 46 | 13 / 46 |
Outcome results
Primary
Change From Baseline in American Spinal Injury (ASIA) Lower Extremities Motor Score
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.
Time frame: 6 months after spinal cord injury
Population: ABP: 46 patients allocated to intervention, 8 died, 3 unable to complete physical exam, 16 lost to follow up CBP: 46 patients allocated to intervention, 7 died, 9 unable to complete physical exam, 11 lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Augmented Blood Pressure | Change From Baseline in American Spinal Injury (ASIA) Lower Extremities Motor Score | 10.79 Scores on a scale | Standard Deviation 16.66 |
| Conventional Blood Pressure | Change From Baseline in American Spinal Injury (ASIA) Lower Extremities Motor Score | 16.16 Scores on a scale | Standard Deviation 18.16 |
p-value: 0.3595% CI: [-16.84, 6.1]t-test, 2 sided
Primary
Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score
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.
Time frame: 6 months after spinal cord injury
Population: ABP: 46 patients allocated to intervention, 8 died, 3 unable to complete physical exam, 16 lost to follow up CBP: 46 patients allocated to intervention, 7 died, 9 unable to complete physical exam, 11 lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Augmented Blood Pressure | Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score | 15.58 Scores on a scale | Standard Deviation 16.23 |
| Conventional Blood Pressure | Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score | 12.63 Scores on a scale | Standard Deviation 13.42 |
p-value: 0.5595% CI: [-6.85, 12.75]t-test, 2 sided
Primary
Change From Baseline in American Spinal Injury Association (ASIA) Sensory Score
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.
Time frame: 6 months after spinal cord injury
Population: ABP: 46 patients allocated to intervention, 8 died, 3 unable to complete physical exam, 16 lost to follow up CBP: 46 patients allocated to intervention, 7 died, 9 unable to complete physical exam, 11 lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Augmented Blood Pressure | Change From Baseline in American Spinal Injury Association (ASIA) Sensory Score | 6.26 Scores on a scale | Standard Deviation 41.32 |
| Conventional Blood Pressure | Change From Baseline in American Spinal Injury Association (ASIA) Sensory Score | 41.63 Scores on a scale | Standard Deviation 58.97 |
p-value: 0.0495% CI: [-68.87, -1.87]t-test, 2 sided
Secondary
International Spinal Cord Injury Quality of Life (ISCIQoL) Basic Data Set
The ISCIQoL Basic Data Set is a 3-item self-report tool of quality of life across three domains: 1. Satisfaction with life as a whole; 2. Satisfaction with physical health; 3. Satisfaction with psychological health. Each domain scores from 0 to 10, and the total score range (sum of the 3 domains) ranges from 0 to 30. Higher scores indicate better perceived quality of life.
Time frame: 6 months after spinal cord injury
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Augmented Blood Pressure | International Spinal Cord Injury Quality of Life (ISCIQoL) Basic Data Set | 19.94 Scores on a scale | Standard Deviation 6.43 |
| Conventional Blood Pressure | International Spinal Cord Injury Quality of Life (ISCIQoL) Basic Data Set | 18.00 Scores on a scale | Standard Deviation 7.31 |
p-value: 0.495% CI: [-2.64, 6.53]ANCOVA
Secondary
Pain Scores on the International Spinal Cord Injury Basic Pain Data Set
Pain Interference with daily activity on the International Spinal Cord Injury Basic Pain Data Set. Pain Interference Score ranges from 0 to 10, with higher scores indicating higher pain levels.
Time frame: 6 months after spinal cord injury
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Augmented Blood Pressure | Pain Scores on the International Spinal Cord Injury Basic Pain Data Set | 5.21 Scores on a scale | Standard Deviation 3.17 |
| Conventional Blood Pressure | Pain Scores on the International Spinal Cord Injury Basic Pain Data Set | 4.86 Scores on a scale | Standard Deviation 3.66 |
p-value: 0.7595% CI: [-1.83, 2.53]ANCOVA
Secondary
Spinal Cord Independence Measure III Score
Spinal Cord Independence Measure III (SCIM III). The total SCIM III Score ranges from 0 to 100 points, with 0 indicating complete dependence and 100 indicating complete independence.
Time frame: 6 months after spinal cord injury
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Augmented Blood Pressure | Spinal Cord Independence Measure III Score | 27.48 Scores on a scale | Standard Deviation 19.43 |
| Conventional Blood Pressure | Spinal Cord Independence Measure III Score | 28.11 Scores on a scale | Standard Deviation 20.82 |
p-value: 0.9295% CI: [-12.48, 11.21]ANCOVA
Other Pre-specified
Cardiovascular Function
Hypotension, hypertension, autonomic dysreflexia, edema, pulmonary embolism, deep venous thrombosis, other cardiovascular condition.
Time frame: 6 months after spinal cord injury
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Augmented Blood Pressure | Cardiovascular Function | 6 Participants |
| Conventional Blood Pressure | Cardiovascular Function | 7 Participants |
p-value: 0.8795% CI: [0.44, 3.65]Chi-squared
Other Pre-specified
Incidence of Respiratory Complications
Incidence of respiratory complications
Time frame: 7 days after randomization or ICU discharge, whichever came first, assessed up to 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Augmented Blood Pressure | Incidence of Respiratory Complications | 36 Participants |
| Conventional Blood Pressure | Incidence of Respiratory Complications | 18 Participants |
p-value: <0.00195% CI: [1.36, 2.94]Chi-squared
Other Pre-specified
Sequential Multiple Organ Assessment (SOFA) Score
Modified Sequential Multiple Organ Assessment (SOFA) score on Day 7 after randomization. The modified SOFA score does not include the points contributed by the Cardiovascular system. The modified SOFA score ranges from 0 to 20, with higher scores indicating greater organ dysfunction and higher mortality risk.
Time frame: 7 days after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Augmented Blood Pressure | Sequential Multiple Organ Assessment (SOFA) Score | 1.40 Scores on a scale | Standard Deviation 1.84 |
| Conventional Blood Pressure | Sequential Multiple Organ Assessment (SOFA) Score | 0.78 Scores on a scale | Standard Deviation 1.33 |
p-value: 0.0895% CI: [-0.08, 1.32]ANCOVA