Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Trauma Research and Combat Casualty Care Collaborative (TRC4) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the effect of various hemodynamic management strategies on functional neurologic outcomes and non-neurologic adverse events in the first 5 days following acute spinal cord injury (SCI). The hemodynamic management strategies assessed include targeting a mean arterial blood pressure (MAP) goal of 85-90 mmHg, targeting a spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg, or targeting normal hemodynamics, which is a MAP goal of ≥65 mmHg.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mean arterial blood pressure (MAP) goal of ≥65 mmHg | Experimental |
| |
| Mean arterial blood pressure (MAP) goal of 85-90 mmHg | Experimental |
| |
| Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mean arterial blood pressure (MAP) goal of ≥65 mmHg | Other | The treatment team will maintain MAP ≥65 mmHg for the first five days following injury. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The severity of a spinal cord injury (SCI) as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) motor score | Upper and lower extremities will be assessed, and motor strength at each spinal cord level will be scored from 0 to 5 (0 indicates total paralysis and 5 indicates active movement against full resistance), with a maximum score of 25 for each extremity, totaling 100 for all four extremities. Total score ranges from 0 to 100, with a higher score indicating a better outcome. | 6 weeks following injury |
| Performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score | There are 3 subscales on the SCIM III: self-care (4 items, score ranging from 0-20), respiration and sphincter management (4 items, score ranging from 0-40), and mobility (9 items, score ranging from 0-40). Total score ranges from 0 to 100, with a higher score indicating a better outcome. | 6 weeks following injury |
| Measure | Description | Time Frame |
|---|---|---|
| Change in motor function as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) motor score | Upper and lower extremities will be assessed, and motor strength at each spinal cord level will be scored from 0 to 5 (0 indicates total paralysis and 5 indicates active movement against full resistance), with a maximum score of 25 for each extremity, totaling 100 for all four extremities. Total score ranges from 0 to 100, with a higher score indicating a better outcome. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Meyer, MD, MS, FACS | Contact | (713) 500-7244 | David.E.Meyer@uth.tmc.edu | |
| Erin Fox | Contact | (713) 500-6273 | Erin.E.Fox@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Meyer, MD, MS, FACS | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mean arterial blood pressure (MAP) goal of 85-90 mmHg | Other | The treatment team will maintain MAP 85-90 mmHg for the first five days following injury. |
|
| Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg | Other | The treatment team will maintain SCPP ≥65 mmHg for the first five days following injury. |
|
| 6 months following injury, 12 months following injury |
| Change in sensory function as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) sensory score | For each side of the body, 28 key sensory points will be assessed by light touch, and each area will be scored from 0 to 2 (0 indicates sensing is absent, 1 indicates sensing is altered, and 2 indicates that sensing is normal). Additionally, for each side of the body 28 key sensory points will be also be assessed by pin prick, and each area will be scored from 0 to 2 (0 indicates sensing is absent, 1 indicates sensing is altered, and 2 indicates that sensing is normal). Scores for light touch and pin prick assessments for both sides of the body will be combined, and the total score ranges from 0 to 224, with a higher score indicating a better outcome. | 6 months following injury, 12 months following injury |
| Change in performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score | There are 3 subscales on the SCIM III: self-care (4 items, score ranging from 0-20), respiration and sphincter management (4 items, score ranging from 0-40), and mobility (9 items, score ranging from 0-40). Total score ranges from 0 to 100, with a higher score indicating a better outcome. | 6 months following injury, 12 months following injury |
| Number of ICU-free days | Number of ICU-free days = [30 days - ICU length of stay in days]. Patients with ICU length of stay >30 days will be assigned a value of zero ICU-free days. | 30 days from baseline |
| Duration of time (hours) receiving goal caloric requirements by enteric nutrition | first 5 days of hospitalization |
| Number of participants developing a central line-associated blood stream infection | Blood stream infection is defined as bacteremia confirmed by blood culture in the presence of a central venous catheter. | Baseline to hospital discharge or 30 days, whichever comes first |
| Number of participants developing a pneumothorax from central venous catheter insertion | Baseline to hospital discharge or 30 days, whichever comes first |
| Number of participants developing pneumonia | Pneumonia is defined as 10,000 colony forming units (cfu)/milliliter (mL) on bronchioalveolar lavage or mini bronchioalveolar lavage, or clinical diagnosis of pneumonia with subsequent antibiotic treatment. | Baseline to hospital discharge or 30 days, whichever comes first |
| Number of participants developing acute kidney injury using the Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE) criteria | Acute kidney injury using the RIFLE criteria is defined as a 50% increase in serum creatinine from baseline or urine output <0.5 mL/h for 6 hours. | Baseline to hospital discharge or 30 days, whichever comes first |
| Number of deaths | Baseline to hospital discharge or 30 days, whichever comes first |
| 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 |
Not provided
Not provided