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

Trial Summary

What is the purpose of this 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.

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 data supports the effectiveness of the treatment Hemodynamic Management for Blood Pressure Management in Spinal Cord Injury?

Some studies suggest that maintaining a higher mean arterial pressure (MAP) in the early stages of spinal cord injury (SCI) may help improve outcomes by preventing low blood pressure, which can worsen the injury. However, there is not enough strong evidence from clinical trials to recommend this as a standard practice, and it should be considered carefully for each patient. ^{1 2 3 4 5}

Is blood pressure management safe for people with spinal cord injury?

There is limited safety data on blood pressure management for spinal cord injury, and while some treatments like vasopressors are used, the risks and target values are not well-defined. Many individuals with spinal cord injury experience blood pressure instability, but few treatments have been proven safe and effective for this population. ^{1 6 7 8 9}

How is the treatment 'Hemodynamic Management' unique for spinal cord injury?

Hemodynamic Management for spinal cord injury is unique because it focuses on maintaining specific blood pressure goals to improve spinal cord blood flow and potentially enhance recovery. This approach often involves using vasopressors (medications that tighten blood vessels and raise blood pressure) to achieve a target mean arterial pressure (MAP) of 85-90 mm Hg for 5-7 days, which is not a standard practice for other conditions. ^{1 2 3 10 11}

Research Team

David Meyer, MD, MS, FACS

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Increased mean arterial pressure goals after spinal cord injury and functional outcome. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Failure of Mean Arterial Pressure Goals to Improve Outcomes Following Penetrating Spinal Cord Injury. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Bet 1: Can induced hypertension improve outcome following acute traumatic spinal cord injury? [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Hemodynamic parameters in patients with acute cervical cord trauma: description, intervention, and prediction of outcome. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Hemodynamic Safety Checklist Can Improve Blood Pressure Monitoring in Patients with Acute Spinal Cord Injury. [2020]

6. England 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Pilot study: advanced haemodynamic monitoring after acute spinal cord injury-Keep the pressure up? [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Influence of arterial blood pressure upon central hemorrhagic necrosis after severe spinal cord injury. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Clinical trial of home blood pressure monitoring following midodrine administration in hypotensive individuals with spinal cord injury. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Spinal cord blood flow and systemic blood pressure after experimental spinal cord injury in rats. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

The impact of blood pressure management after spinal cord injury: a systematic review of the literature. [2022]