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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-SC150250 | Other Grant/Funding Number | United States Department of Defense, CDMRP |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this study is to learn more about how participants heal from acute spinal cord injury.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Augmented Blood Pressure | Experimental | Subjects will have their blood pressure kept in a higher range. |
|
| Conventional Blood Pressure | No Intervention | Subjects will have their blood pressure kept in a normal range. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented Blood Pressure | Other | Subjects will have their blood pressure kept in a higher range. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after spinal cord injury |
| 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. | 6 months after spinal cord injury |
| 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. | 6 months after spinal cord injury |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after spinal cord injury |
| Pain Scores on the International Spinal Cord Injury Basic Pain Data Set |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Respiratory Complications | Incidence of respiratory complications | 7 days after randomization or ICU discharge, whichever came first, assessed up to 7 days |
| Cardiovascular Function | Hypotension, hypertension, autonomic dysreflexia, edema, pulmonary embolism, deep venous thrombosis, other cardiovascular condition. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriam Treggiari, MD, PhD, MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Yale University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40965887 | Derived | Sajdeya R, Yanez ND, Kampp M, Goodman MD, Zonies D, Togioka B, Nunn A, Winfield RD, Martin ND, Kohli A, Huynh TT, Okonkwo DO, Poblete RA, Gilmore EJ, Chesnut RM, Bunnell AE, Ohnuma T, Hashemaghaie M, Treggiari MM. Early Blood Pressure Targets in Acute Spinal Cord Injury: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2525364. doi: 10.1001/jamanetworkopen.2025.25364. | |
| 33003016 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Augmented Blood Pressure | Subjects will have their blood pressure kept in a higher range. |
| FG001 | Conventional Blood Pressure | Subjects will have their blood pressure kept in a normal range. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2018 |
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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. |
| 6 months after spinal cord injury |
| 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. | 6 months after spinal cord injury |
| 6 months after spinal cord injury |
| 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. | 7 days after randomization |
| New Haven |
| Connecticut |
| 06511 |
| United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Atrium Health F.H. Sammy Ross Trauma Center | Charlotte | North Carolina | 28203 | United States |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Derived |
| Weinberg JA, Farber SH, Kalamchi LD, Brigeman ST, Bohl MA, Varda BM, Sioda NA, Radosevich JJ, Chapple KM, Snyder LA. Mean arterial pressure maintenance following spinal cord injury: Does meeting the target matter? J Trauma Acute Care Surg. 2021 Jan 1;90(1):97-106. doi: 10.1097/TA.0000000000002953. |
| COMPLETED |
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| NOT COMPLETED |
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1 participant in the ABP and 1 participant in the CBP group were excluded due to inadequate consent documentation
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| ID | Title | Description |
|---|---|---|
| BG000 | Augmented Blood Pressure | Subjects will have their blood pressure kept in a higher range. |
| BG001 | Conventional Blood Pressure | Subjects will have their blood pressure kept in a normal range. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Baseline American Spinal Injury Association (ASIA) Score | The ASIA Score has a motor and a sensory component. The maximum Upper Extremities Motor Score (UEMS) is 50, the maximum Lower Extremities Motor Score (LEMS) is 50, the maximum Total Sensory Score (sum of pin prick [max 112] and light touch [max 112]) is 224. The minimum score is 0. Higher scores indicate better neurological outcome. | A complete neurological exam could not be obtained in 3 patients | Mean | Standard Deviation | Score |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Standard Deviation | Scores on a scale | 6 months after spinal cord injury |
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| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 6 months after spinal cord injury |
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| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 6 months after spinal cord injury |
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| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 6 months after spinal cord injury |
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| Other Pre-specified | Incidence of Respiratory Complications | Incidence of respiratory complications | Posted | Count of Participants | Participants | 7 days after randomization or ICU discharge, whichever came first, assessed up to 7 days |
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| Other Pre-specified | Cardiovascular Function | Hypotension, hypertension, autonomic dysreflexia, edema, pulmonary embolism, deep venous thrombosis, other cardiovascular condition. | Posted | Count of Participants | Participants | 6 months after spinal cord injury |
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| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 7 days after randomization |
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| 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. | 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 | Posted | Mean | Standard Deviation | Scores on a scale | 6 months after spinal cord injury |
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| 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. | 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 | Posted | Mean | Standard Deviation | Scores on a scale | 6 months after spinal cord injury |
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From enrollment up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Augmented Blood Pressure | Subjects will have their blood pressure kept in a higher range. | 8 | 46 | 12 | 46 | 0 | 46 |
| EG001 | Conventional Blood Pressure | Subjects will have their blood pressure kept in a normal range. | 7 | 46 | 13 | 46 | 0 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
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| Respiratory Complications | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sepsis/Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miriam Treggiari | Duke University | 9196819933 | miriam.treggiari@duke.edu |
| Aug 1, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| Total Sensory Score |
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