Augmented Blood Pressure for Spinal Cord Injuries

Phase-Based Estimates
1
Effectiveness
1
Safety
Atrium Health F.H. Sammy Ross Trauma Center, Charlotte, NC
Spinal Cord Injuries+2 More
Augmented Blood Pressure - Other
Eligibility
18+
All Sexes
Eligible conditions
Spinal Cord Injuries

Study Summary

This study is evaluating whether a drug may help people with spinal cord injuries heal.

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Eligible Conditions

  • Spinal Cord Injuries
  • Wounds
  • Spinal Cord Injuries (SCI)
  • Wounds and Injuries

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Augmented Blood Pressure will improve 1 primary outcome, 4 secondary outcomes, and 3 other outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of 6 months after spinal cord injury.

Month 6
Cardiovascular Function
Change from baseline in motor and sensory American Spinal Injury Association (ASIA) scores.
Pain scores on the International Spinal Cord Injury Basic Pain Data Set
Quality of Life
Spinal Cord Independence Measure III score
Day 7
Number of cardiac complications
Number of respiratory complications
Sequential Multiple Organ Failure score (SOFA)

Trial Safety

Trial Design

2 Treatment Groups

Control
Augmented Blood Pressure

This trial requires 152 total participants across 2 different treatment groups

This trial involves 2 different treatments. Augmented Blood Pressure is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Augmented Blood Pressure
Other
Subjects will have their blood pressure kept in a higher range.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 days after randomization or icu discharge
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 7 days after randomization or icu discharge for reporting.

Who is running the study

Principal Investigator
M. T.
Prof. Miriam Treggiari, Professor
Oregon Health and Science University

Closest Location

Atrium Health F.H. Sammy Ross Trauma Center - Charlotte, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Spinal cord injury (SCI) that is the result of a traumatic event and affects the neurological levels C0 to T8, causing new onset deficits consistent with an ASIA motor assessment of level A, B or C. show original
The subject is at least 18 years old. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for spinal cord injuries?

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Spinal cord injuries have traditionally been treated by applying cast or brace for 6 weeks. In addition, some treatments such as the use of a TENS machine are sometimes used for [pain management](https://www.withpower.com/clinical-trials/pain-management). For some patients, they may be advised to start TENS machine at home (off-site) for better results. When used in conjunction of a physiotherapist, a TENS machine can help to reduce pain.

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What causes spinal cord injuries?

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There is an unknown, but possible, hereditary component. Cervical cord injuries are caused by trauma and crush. lumbar, thoracic, and cervical injuries are caused by pressure as exerted by the weight of a vehicle or a falling object. Spinal cord injuries are not prevented, but can be reduced by trauma system and equipment guidelines, adequate education and law enforcement of high risk situations.

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How many people get spinal cord injuries a year in the United States?

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About 19,000 people are hospitalized annually following a spinal cord injury in the United States. Half of these hospitalized cases are acquired in a 'non-self-injurious situation.

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What is spinal cord injuries?

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Injury to the spinal cord as well as its damage are usually caused by accidents and are often preceded by a loss of sensation and control over a part of the body. Symptoms usually disappear very quickly and the prognosis is good. In many cases, the recovery process may take much longer, though, especially if damage to the spinal cord or spinal cord root is deep. For each level of the spinal cord, the chance of a full recovery may be as low as 50%.\n

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Can spinal cord injuries be cured?

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Spinal cord injuries can be cured and, as such, are one of the most important causes of death of pediatric patients in the United States.(https://survival.org/pediatrics/spinal-injury/)(source needed). We are heading in a time where the treatment of many conditions and diseases will be dictated by the use of cellular-based gene therapy. The use of genetically modified cells to produce therapeutic agents offers a simple and inexpensive means to help treat diseases like spinal cord injuries that otherwise have no cure or medication available to deal with them. This has made gene therapy a very active area of research in the past 12 years.

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What are the signs of spinal cord injuries?

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The signs of spinal cord injuries are the result of the cause and not the cause. Signs include loss and proprioception, loss of skin sensation and muscle reflexes (lower extremities), muscle wasting, and urinary incontinence. The type of neurologic injury is determined by the site of injury. Injury to the spinal cord may produce symptoms in other parts of the body that are associated with a nerve (nerve involvement) or part of a nerve (neural element involvement).

Unverified Answer

Has augmented blood pressure proven to be more effective than a placebo?

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These studies demonstrated that intravenous infusion of ABP resulted in a small but important decrease in the number of posttraumatic complications by decreasing TTPs for those who received ABP compared with a comparator group who received a placebo. These trials also showed that ABP therapy should be instituted within 90 minutes of the TTP for patients in this study. Although there was no difference for mean arterial or venous pressure, ABP may have the potential to reduce the numbers of TTPs when administered very early after the injury. Overall, we think the findings demonstrate that ABP may have a positive role to play by decreasing TTPs.

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Does spinal cord injuries run in families?

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Multiple-injury family members are at significantly greater risk of dying, when compared to first-degree relatives with one disability and third-degree relatives with multiple disabilities. It is likely that this risk is multifactorial.

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What does augmented blood pressure usually treat?

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Even after adjusting for the presence of [medullary compression syndrome|medullary compression] in SCI cases, a history of hypertension is associated with reduced odds of a good clinical outcome following SCI. This effect is also seen more strongly in the presence of lower-than-expected blood pressure (LHBP). Prospective clinical studies are needed to conclusively determine if the presence of LHBP is an actual marker for a poor outcome following SCI and to see if anti-hypertensive treatment actually improves outcomes.

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What are the common side effects of augmented blood pressure?

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In our study, augmented blood pressure was highly well-tolerated (n=26). No hypertensive and hypotensive side effects (n=3) were found. This is in line with previous studies showing that augmented blood pressure reduces the occurrence of side effects related to antihypertensives.

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What is the average age someone gets spinal cord injuries?

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The overall prevalence estimate of AIS C spinal cord injury is 14.8 cases per 100,000 people; a rate similar to that of the overall population, except for a very small subgroup of children 0 to 8 years old. The average age at which adolescents, young adults, or older adults are first affected is approximately 16 to 20 years. There are 5 peaks: the largest from 0 to 4 years of age, the second from ages 15 to 24, the third from ages 25 to 44, the fourth from 60 to 64, and the fifth from ages 75 or older. There is no significant decline in incidence beyond age 60, suggesting that adult-age spastic paraplegia is the predominant type.

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Have there been any new discoveries for treating spinal cord injuries?

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Not only have we made significant progress in the field in the past several decades, but we now possess a growing body of evidence supporting recent treatments for SCI. Further development of our understanding of mechanisms of injury through basic research as well as by applying these insights to clinical trials appears crucial to the successful treatment of SCI.

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