Blood Pressure Management for Spinal Cord Injury

Overseen By Erin Fox

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Preexisting neurologic, Severe brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 1 week

228 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different ways to manage blood pressure in the first few days after a spinal cord injury to assess its impact on recovery and side effects. Researchers are testing three strategies: maintaining normal blood pressure levels, slightly higher levels, or ensuring good blood flow to the spinal cord. This approach is part of a broader strategy called Hemodynamic Management. The trial seeks participants with traumatic spinal cord injuries, excluding those with injuries from gunshots or preexisting conditions affecting the spine or brain. Participants must not have other injuries requiring specific blood pressure management. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance recovery strategies for spinal cord injuries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these hemodynamic management strategies are safe for spinal cord injury patients?

Research has shown that managing blood pressure in people with sudden spinal cord injuries can be done safely. One study found that maintaining stable blood pressure, either by targeting a specific range (85-90 mmHg) or ensuring adequate blood flow to the spinal cord (≥65 mmHg), helps prevent complications. These methods ensure the spinal cord receives enough blood, which is vital after an injury.

Another study found that using a checklist to monitor blood flow improves blood pressure management in these patients, helping to prevent issues like low blood pressure or sudden spikes. While these treatments aim to keep blood pressure steady, individual responses may vary. Overall, these methods are generally well-tolerated, and past research supports their safety in managing blood pressure after a spinal cord injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different blood pressure management strategies for spinal cord injury patients, aiming to optimize recovery. Unlike standard approaches that often target general blood pressure levels, this trial tests specific goals for mean arterial pressure (MAP) and spinal cord perfusion pressure (SCPP). By comparing MAP goals of ≥65 mmHg and 85-90 mmHg, and an SCPP goal of ≥65 mmHg, the trial seeks to determine the most effective method for enhancing blood flow to the injured spinal cord. These insights could lead to more tailored and effective treatment protocols for spinal cord injuries, potentially improving patient outcomes significantly.

What evidence suggests that this trial's hemodynamic management strategies could be effective for spinal cord injury?

This trial will compare different blood pressure management strategies for spinal cord injury. Research has shown that maintaining blood pressure levels above 85 mmHg after a spinal cord injury can improve nerve function. One arm of this trial will target a mean arterial blood pressure (MAP) goal of 85-90 mmHg, as some studies suggest this range aids recovery by enhancing blood and oxygen flow to the injured area. Another arm will focus on a MAP goal of ≥65 mmHg, while a third arm will target a spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg. Research suggests that maintaining SCPP at 65 mmHg or higher might lead to better long-term nerve function by improving blood flow directly to the spinal cord, which may be more effective than focusing solely on overall blood pressure. ^{6 7 8 9 10}

Who Is on the Research Team?

David Meyer, MD, MS, FACS

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals who have recently suffered an acute spinal cord injury. The study focuses on the first 5 days after the injury and aims to find out if managing blood pressure in different ways can affect recovery.

Inclusion Criteria

I have a spinal cord injury due to trauma.

Exclusion Criteria

My injury is below the L1 level of the spinal cord.

Not expected to survive >24h

Cord transection identified by radiologist and agreed upon by the spine surgery team

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo hemodynamic management strategies for 5 days following acute spinal cord injury

1 week

Daily monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Regular assessments at 6 weeks

Extended Follow-up

Long-term monitoring of neurologic and non-neurologic outcomes

12 months

Assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Hemodynamic Management

Trial Overview The trial is testing three strategies for managing blood pressure: one targets a mean arterial pressure (MAP) of 85-90 mmHg, another aims for a spinal cord perfusion pressure (SCPP) of at least 65 mmHg, and the last one seeks to maintain normal MAP of at least 65 mmHg.

How Is the Trial Designed?

Group I: Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg Experimental Treatment 1 Intervention

Group II: Mean arterial blood pressure (MAP) goal of ≥65 mmHg Experimental Treatment 1 Intervention

Group III: Mean arterial blood pressure (MAP) goal of 85-90 mmHg Experimental Treatment 1 Intervention

Hemodynamic Management is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Blood Pressure Management for:

• Acute Spinal Cord Injury
• Traumatic Spinal Cord Injury

Approved in European Union as Hemodynamic Stabilization for:

• Spinal Cord Injury
• Neurological Trauma

Approved in Canada as Spinal Cord Injury Blood Pressure Regulation for:

• Acute Spinal Cord Injury
• Spinal Cord Trauma

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Trauma Research and Combat Casualty Care Collaborative (TRC4)

Collaborator

Trials

1

Recruited

230+

Published Research Related to This Trial

In a study of 14 patients with complete penetrating spinal cord injuries, only 7.1% showed any neurological recovery despite receiving vasopressors to maintain high mean arterial pressure (MAP) for an average of over 101 hours.

The use of vasopressors was associated with a high rate of cardiogenic complications (71.43%), suggesting that these interventions may do more harm than good in terms of neurological outcomes for patients with penetrating spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of Mean Arterial Pressure Goals to Improve Outcomes Following Penetrating Spinal Cord Injury. Readdy, WJ., Saigal, R., Whetstone, WD., et al.[2019]

In a study of 105 patients with acute spinal cord injury, higher theoretical mean arterial pressure (MAP) goals were associated with more episodes of relative hypotension and a greater need for vasopressors, but these factors did not lead to improved outcomes in motor function during hospitalization.

The findings suggest that setting arbitrary high MAP goals may not be effective in improving hospital outcomes for spinal cord injury patients, as the change in motor scores was not significantly affected by hypotensive episodes or vasopressor use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased mean arterial pressure goals after spinal cord injury and functional outcome. Martin, ND., Kepler, C., Zubair, M., et al.[2022]

Individuals with spinal cord injury (SCI) above the sixth thoracic vertebra experience significantly lower blood pressure and cerebral blood flow velocities compared to able-bodied controls, which may negatively affect their daily activities.

The study demonstrated good reliability in measuring brachial blood pressure and cerebral blood flow velocities, but found that finger blood pressure measurements were less reliable, highlighting the need for careful assessment methods in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inter-day reliability of blood pressure and cerebral blood flow velocities in persons with spinal cord injury and intact controls. Wecht, JM., Weir, JP., Bauman, WA.[2018]

Observational studies suggest that maintaining a high mean arterial pressure (MAP) in the early phase of traumatic spinal cord injury (SCI) may reduce morbidity and mortality, but there is not enough trial data to establish this as a standard practice.

Inducing hypertension carries risks, so any decision to augment blood pressure should be made carefully and tailored to each individual case.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bet 1: Can induced hypertension improve outcome following acute traumatic spinal cord injury? Bertram-Ralph, E., Horner, D.[2018]

In a study involving 25 rats, it was found that moderate hypertension improved spinal cord blood flow after a mild spinal cord injury, while hypotension decreased blood flow linearly.

After severe spinal cord injury, attempts to induce hypertension did not enhance blood flow at the injury site and could potentially worsen conditions like hemorrhage and edema, suggesting that maintaining normal blood pressure is crucial for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord blood flow and systemic blood pressure after experimental spinal cord injury in rats. Guha, A., Tator, CH., Rochon, J.[2019]

In a pilot study of 30 patients with acute spinal cord injury, key hemodynamic parameters like systemic vascular resistance index (SVRI) and central venous pressure (CVP) were found to deviate from reference ranges, suggesting that current target values may need adjustment.

The study revealed that norepinephrine treatment negatively impacted mean arterial pressure (MAP) and other hemodynamic measures, indicating that reducing vasopressor use could be beneficial in managing patients with acute spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study: advanced haemodynamic monitoring after acute spinal cord injury-Keep the pressure up? Drotleff, N., Jansen, O., Weckwerth, C., et al.[2022]

In a study investigating spinal cord injury, blocking the normal increase in systemic blood pressure with chlorisondamine did not affect the development of hemorrhagic necrosis in the spinal cord.

This suggests that the temporary rise in blood pressure following spinal cord injury is likely not a significant contributor to the damage caused by hemorrhagic necrosis at the injury site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of arterial blood pressure upon central hemorrhagic necrosis after severe spinal cord injury. Alderman, JL., Osterholm, JL., D'Amore, BR., et al.[2019]

In a study of 50 patients with acute spinal cord injury, maintaining a mean blood pressure above 90 mm Hg through aggressive hemodynamic monitoring and treatment improved patient outcomes by reducing ischemia and allowing for potential early surgical intervention.

The analysis revealed that patients with clinically complete motor deficits (Frankel Grade A+B) showed no functional improvement when specific hemodynamic parameters indicated severe deficits, suggesting that these measurements could help predict recovery potential in SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic parameters in patients with acute cervical cord trauma: description, intervention, and prediction of outcome. Levi, L., Wolf, A., Belzberg, H.[2022]

Maintaining a mean arterial pressure (MAP) of 85-90 mm Hg for 5-7 days after spinal cord injury (SCI) may improve neurological outcomes, based on evidence from two prospective studies.

While various vasopressors like norepinephrine and phenylephrine are recommended for BP management in SCI, dopamine is associated with more complications, suggesting it may be less safe for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of blood pressure management after spinal cord injury: a systematic review of the literature. Saadeh, YS., Smith, BW., Joseph, JR., et al.[2022]

Midodrine (10 mg) significantly increased average systolic blood pressure and reduced the number of hypotensive episodes in individuals with spinal cord injury, demonstrating its efficacy in managing blood pressure instability.

However, while midodrine improved blood pressure, it also led to increased fluctuations in blood pressure and worsened symptoms of autonomic dysreflexia, indicating potential safety concerns that need to be considered in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial of home blood pressure monitoring following midodrine administration in hypotensive individuals with spinal cord injury. Wecht, JM., Weir, JP., Katzelnick, CG., et al.[2023]

The introduction of a blood pressure monitoring checklist and staff education improved the management of mean arterial pressure (MAP) in patients with acute spinal cord injury (SCI) at a tertiary hospital, increasing the average number of MAP readings and reducing the proportion of low MAP recordings.

Patients with polytrauma were identified as being at higher risk for low MAP readings, highlighting the need for targeted monitoring and management in this group to meet the recommended MAP targets of 85-90 mm Hg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Hemodynamic Safety Checklist Can Improve Blood Pressure Monitoring in Patients with Acute Spinal Cord Injury. Sewell, MD., Vachhani, K., Hockings, J., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8081322/

Current practices and goals for mean arterial pressure and ... The mainstay of treatment for acute traumatic spinal cord injury (SCI) is to artificially elevate the patient's mean arterial pressure (MAP) to >85 mmHg.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839069

Early Blood Pressure Targets in Acute Spinal Cord Injury This randomized clinical trial of patients with spinal cord injury examines whether augmented blood pressure (mean arterial pressure >85-90 mm Hg)

3. tsaco.bmj.com tsaco.bmj.com/content/10/3/e001768

Does mean arterial pressure augmentation improve ... Percentage of treatment time at a MAP goal of 85 mm Hg was not significantly associated with an increased odd of neurological improvement, OR ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12447234/

Early Blood Pressure Targets in Acute Spinal Cord Injury Both the ABP and CBP groups maintained MAP targets of greater than 85 to 90 mm Hg and greater than 65 to 70 mm Hg, respectively (Figure 2); ...

5. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-025-05531-3

Effect of blood pressure threshold on adverse outcomes in ... In a subgroup analysis comparing MAP thresholds, patients whose MAP fell below 85 mmHg had higher odds of adverse functional outcome as compared ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12265288/

Effect of blood pressure threshold on adverse outcomes in ... A clinical practice guideline for the management of patients with acute spinal cord injury: recommendations on hemodynamic management.

7. nature.com nature.com/articles/s41591-025-03614-w

An implantable system to restore hemodynamic stability ... These results demonstrate that EES applied over the lumbosacral spinal cord failed to consistently trigger meaningful pressor responses, as ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964888/

A Clinical Practice Guideline for the Management of Patients ... A hemodynamic safety checklist can improve blood pressure monitoring in patients with acute spinal cord injury. World Neurosurg. 2019;128 ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1471489221001569

Management of blood pressure disorders in individuals ... Common blood pressure problems in the SCI population include persistently low blood pressure with bouts of orthostatic hypotension and autonomic dysreflexia.

10. thejns.org thejns.org/focus/view/journals/neurosurg-focus/43/5/article-pE20.xml

The impact of blood pressure management after spinal cord ... A total of 11 studies were identified in which BP and neurological outcome data for SCI patients during the acute postinjury period were collected (Table 1).