Spinal Cord InjuriesNCT06451133
Hemodynamic Management Following Acute Traumatic Spinal Cord Injury
A study testing Mean arterial blood pressure (MAP) goal of ≥65 mmHg, Mean arterial blood pressure (MAP) goal of 85-90 mmHg and Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Mean arterial blood pressure (MAP) goal of ≥65 mmHg, Mean arterial blood pressure (MAP) goal of 85-90 mmHg and Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic spinal cord injury
Who cannot join
- Patients with an injury from a trauma that penetrates the spinal cord (i.e., gunshot or knife wound resulting in cord transection)
- Preexisting neurologic or spinal cord injury
- Severe traumatic brain injury as measured by a best resuscitated Glasgow Coma Scale (GCS) score of <8 at 24 hours following injury
- Presence of traumatic injuries that preclude spine surgery within 24 hours of presentation
- Concomitant injury/illness requiring targeted blood pressure management (e.g., injury to the aorta, aortic dissection, hemorrhagic stroke)
- Preexisting history of neuromotor disorders (i.e., cerebral palsy, Parkinson disease, etc.)
Show all 11Show fewer
- Not expected to survive >24h
- Cord transection identified by radiologist and agreed upon by the spine surgery team
- Injury below spinal cord level L1
- Prisoners
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
David Meyer, MD, MS, FACS, 713-500-7244, David.E.Meyer@uth.tmc.edu
Erin Fox, (713) 500-6273, Erin.E.Fox@uth.tmc.edu
About this study
Official title: Hemodynamic Management Following Acute Traumatic Spinal Cord Injury: A Randomized, Controlled Trial
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Mean arterial blood pressure (MAP) goal of ≥65 mmHg, Mean arterial blood pressure (MAP) goal of 85-90 mmHg, Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mean arterial blood pressure (MAP) goal of ≥65 mmHgOther
The treatment team will maintain MAP ≥65 mmHg for the first five days following injury.
Mean arterial blood pressure (MAP) goal of 85-90 mmHgOther
The treatment team will maintain MAP 85-90 mmHg for the first five days following injury.
Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHgOther
The treatment team will maintain SCPP ≥65 mmHg for the first five days following injury.
| Study group | Role | What they receive |
|---|---|---|
| Mean arterial blood pressure (MAP) goal of ≥65 mmHg | Experimental | Not described Receives: Other: Mean arterial blood pressure (MAP) goal of ≥65 mmHg |
| Mean arterial blood pressure (MAP) goal of 85-90 mmHg | Experimental | Not described Receives: Other: Mean arterial blood pressure (MAP) goal of 85-90 mmHg |
| Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg | Experimental | Not described Receives: Other: Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks following injury
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days from baseline
Duration of time (hours) receiving goal caloric requirements by enteric nutrition
Measured: 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.
Measured: Baseline to hospital discharge or 30 days, whichever comes first
Number of participants developing a pneumothorax from central venous catheter insertion
Measured: 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.
Measured: 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.
Measured: Baseline to hospital discharge or 30 days, whichever comes first
Number of deaths
Measured: Baseline to hospital discharge or 30 days, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start3 Jul 2024
- Primary completion15 Sep 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Trauma Research and Combat Casualty Care Collaborative (TRC4)
- Responsible party
- Principal investigator, David E. Meyer, MD, MS, FACS, The University of Texas Health Science Center, Houston
- Investigators
- David Meyer, MD, MS, FACS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451133
- Sponsor's protocol ID
- HSC-MS-24-0405
- Status last verified
- Dec 2024
- First submitted
- 4 Jun 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Management Following Acute Traumatic Spinal Cord Injury: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06451133
- Acronym / sponsor ID
- HSC-MS-24-0405
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Trauma Research and Combat Casualty Care Collaborative (TRC4)
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mean arterial blood pressure (MAP) goal of ≥65 mmHg | Experimental | Other: Mean arterial blood pressure (MAP) goal of ≥65 mmHg |
| Mean arterial blood pressure (MAP) goal of 85-90 mmHg | Experimental | Other: Mean arterial blood pressure (MAP) goal of 85-90 mmHg |
| Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg | Experimental | Other: Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Traumatic spinal cord injury
Key exclusion criteria (11 listed)
- Patients with an injury from a trauma that penetrates the spinal cord (i.e., gunshot or knife wound resulting in cord transection)
- Preexisting neurologic or spinal cord injury
- Severe traumatic brain injury as measured by a best resuscitated Glasgow Coma Scale (GCS) score of <8 at 24 hours following injury
- Presence of traumatic injuries that preclude spine surgery within 24 hours of presentation
- Concomitant injury/illness requiring targeted blood pressure management (e.g., injury to the aorta, aortic dissection, hemorrhagic stroke)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mean arterial blood pressure (MAP) goal of ≥65 mmHgThe treatment team will maintain MAP ≥65 mmHg for the first five days following injury. | Other | Mean arterial blood pressure (MAP) goal of ≥65 mmHg |
| Mean arterial blood pressure (MAP) goal of 85-90 mmHgThe treatment team will maintain MAP 85-90 mmHg for the first five days following injury. | Other | Mean arterial blood pressure (MAP) goal of 85-90 mmHg |
| Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHgThe treatment team will maintain SCPP ≥65 mmHg for the first five days following injury. | Other | Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg |
Primary outcome
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
Time frame: 6 weeks following injury
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.
Performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score
Time frame: 6 weeks following injury
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.
10 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 6 months following injury, 12 months following injury
Number of ICU-free days
Time frame: 30 days from baseline
Duration of time (hours) receiving goal caloric requirements by enteric nutrition
Time frame: first 5 days of hospitalization
Number of participants developing a central line-associated blood stream infection
Time frame: Baseline to hospital discharge or 30 days, whichever comes first
Number of participants developing a pneumothorax from central venous catheter insertion
Time frame: Baseline to hospital discharge or 30 days, whichever comes first
Number of participants developing pneumonia
Time frame: 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
Time frame: Baseline to hospital discharge or 30 days, whichever comes first
Number of deaths
Time frame: Baseline to hospital discharge or 30 days, whichever comes first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Meyer, MD, MS, FACS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mean arterial blood pressure (MAP) goal of ≥65 mmHg, Mean arterial blood pressure (MAP) goal of 85-90 mmHg and Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Meyer, MD, MS, FACS ((713) 500-7244, David.E.Meyer@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 weeks following injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.