SCPP Management for Spinal Cord Injury

(CASPER Trial)

Recruiting at 7 trial locations

Overseen By Allan Aludino

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Motor incomplete SCI, Penetrating injury, Neurodegenerative disorders, Thromboembolic disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 7 days

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to aid recovery from recent spinal cord injury (SCI), which involves damage to the spinal cord that can result in loss of movement and sensation. The focus is on managing Spinal Cord Perfusion Pressure (SCPP) to determine if it improves movement and sensation. Participants will have a special catheter inserted to measure pressure and collect fluid samples for further research. The trial seeks individuals who have experienced a non-penetrating spinal cord injury to the neck or upper-to-mid back within the last 48 hours and have had a catheter placed as part of their treatment. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new recovery methods 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 team or your doctor.

What prior data suggests that this protocol is safe for spinal cord injury patients?

Research has shown that managing blood flow to the spinal cord in patients with sudden spinal cord injuries can be beneficial. Studies suggest that maintaining this blood flow at or above 65 mmHg might aid recovery. This involves carefully monitoring and adjusting blood pressure around the spinal cord to ensure adequate blood supply.

Previous research has not identified major safety issues with this method. Most patients tolerate it well, and no serious problems have been directly linked to this treatment. However, like any medical procedure, risks may exist, and results can vary among individuals.

It is important to consider this information and discuss it with a healthcare provider when considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SCPP Management for spinal cord injury because it focuses on actively managing Spinal Cord Perfusion Pressure (SCPP) to ensure it stays at or above 65 mmHg. Unlike traditional treatments that may focus on stabilizing the spine or reducing inflammation, this approach aims to optimize blood flow directly to the injured spinal cord, potentially improving outcomes. This method could offer a more targeted and immediate way to support the healing process after an injury, which might lead to better recovery rates and improved quality of life for patients.

What evidence suggests that SCPP Management is effective for spinal cord injury?

Research has shown that maintaining blood flow pressure to the spinal cord at or above 65 mmHg can aid recovery after spinal cord injuries. Studies found that 33% to 60% of patients with complete spinal cord injuries and 88% to 92% of those with partial injuries experienced improved nerve function with careful blood flow management. This trial will actively manage Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg, adjusting blood and spinal pressure to enhance blood flow to the spinal cord. These findings suggest that managing blood flow significantly aids nerve recovery. ^{1 4 5 6 7}

Who Is on the Research Team?

Brian Kwon, MD, PhD

Principal Investigator

University of British Columbia, Faculty of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with acute traumatic spinal cord injury from C0 to T12, treated surgically or non-surgically. Participants must have a lumbar intrathecal catheter inserted within 48 hours of injury and an initial blood sample taken within 24 hours. Excluded are those with minor motor injuries (AIS D), sensory-only deficits, penetrating injuries, other major traumas or medical conditions that could affect safety or results.

Inclusion Criteria

I have had a spinal cord injury that was treated without surgery.

I am 17 years old or older, or I meet my area's legal age requirement.

I will have a lumbar catheter inserted for clinical management after an injury.

Exclusion Criteria

I have nerve pain from a single spinal nerve.

I have a condition like Parkinson's, Alzheimer's, Huntington's, MS, or ALS.

My spinal injury is below the L1 vertebra or affects the cauda equina.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

Treatment

Active management of Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg with MAP augmentation and CSF drainage

7 days

Continuous monitoring with CSF and blood samples collected at 8-hour intervals

Follow-up

Participants are monitored for neurologic recovery using the ISNCSCI examination at Baseline, Days 1-7, and months 3, 6, and 12

12 months

Multiple visits at specified intervals

What Are the Treatments Tested in This Trial?

Interventions

• SCPP Management

Trial Overview The study tests if managing Spinal Cord Perfusion Pressure (SCPP) at ≥65 mmHg improves neurological recovery in spinal cord injury patients. It involves monitoring SCPP via a lumbar catheter and assessing recovery using the ASIA Impairment Scale. The study also collects cerebrospinal fluid and blood samples for future biomarker research.

How Is the Trial Designed?

Group I: SCP Pressure Management Experimental Treatment 1 Intervention

Active management of Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg.

SCPP Management is already approved in Canada, United States for the following indications:

Approved in Canada as SCPP Management for:

• Acute Spinal Cord Injury
• Spinal Paralysis
• Fractured Spine

Approved in United States as SCPP Management for:

• Acute Spinal Cord Injury
• Spinal Paralysis
• Fractured Spine

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Rick Hansen Institute

Collaborator

Trials

10

Recruited

770+

Published Research Related to This Trial

In a study of 13 patients undergoing aortic aneurysm repair, spinal cord perfusion pressure (SCPP) was directly monitored, revealing a significant drop during surgery but a gradual recovery postoperatively, which is crucial for spinal cord function.

Despite a marked decrease in SCPP during the procedure, all but one patient regained normal spinal cord function, indicating that monitoring SCPP could help prevent critical drops that might lead to complications like paraparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct spinal cord perfusion pressure monitoring in extensive distal aortic aneurysm repair. Etz, CD., Di Luozzo, G., Zoli, S., et al.[2022]

In patients with acute cervical traumatic spinal cord injuries, maintaining a spinal cord perfusion pressure (SCPP) between 80-90 mmHg is crucial for optimal diaphragmatic and intercostal muscle function, which are essential for effective breathing.

Low SCPP (<60 mmHg) is linked to reduced breathing effort, while SCPP levels above 100 mmHg can also impair muscle function, suggesting that interventions to keep SCPP within the optimal range may help improve respiratory function and reduce the duration of neuro-intensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord perfusion pressure correlates with breathing function in patients with acute, cervical traumatic spinal cord injuries: an observational study. Visagan, R., Boseta, E., Zoumprouli, A., et al.[2023]

Cerebrospinal fluid drainage (CSFD) significantly reduced intrathecal pressure (ITP) and improved spinal cord perfusion pressure (SCPP) in patients with acute cervical spinal cord injury, indicating its potential as a therapeutic intervention.

In a small study of 11 patients, those receiving CSFD showed greater improvements in motor function scores over 180 days compared to the control group, with no adverse events linked to the CSFD procedure, highlighting its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebrospinal Fluid Drainage in Patients with Acute Spinal Cord Injury: A Multi-Center Randomized Controlled Trial. Theodore, N., Martirosyan, N., Hersh, AM., et al.[2023]

The implementation of a spinal cord perfusion pressure (SCPP) maintenance protocol in 15 patients with traumatic spinal cord injury was safe, with no complications related to the lumbar subarachnoid drain used for monitoring.

After 7 days, 33.3% of patients showed improvement in their American Spinal Injury Association Impairment Scale (AIS) scores, indicating that the SCPP protocol may be effective in enhancing recovery outcomes in acute spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Implementation of Novel Spinal Cord Perfusion Pressure Protocol in Acute Traumatic Spinal Cord Injury at U.S. Level I Trauma Center: TRACK-SCI Study. Yue, JK., Hemmerle, DD., Winkler, EA., et al.[2020]

Maintaining spinal cord perfusion pressure (SCPP) is a stronger predictor of favorable outcomes after traumatic spinal cord injury (SCI) than just focusing on mean arterial pressure (MAP), according to a systematic review of 24 clinical studies.

Interventions like laminectomy combined with durotomy may lead to better outcomes compared to laminectomy alone, but more high-quality studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal interventions to optimize spinal cord perfusion in patients with acute traumatic spinal cord injuries: a systematic review. Weber-Levine, C., Judy, BF., Hersh, AM., et al.[2022]

Optimizing spinal cord perfusion through mean arterial pressure (MAP) support for patients with acute spinal cord injuries shows uncertain effects on neurological recovery, and using vasopressors to support MAP may increase the risk of cardiac adverse events, based on a review of 20 observational studies and 1 randomized controlled trial.

While increasing spinal cord perfusion pressure (SCPP) may improve neurological recovery, monitoring SCPP with intradural catheters carries risks such as cerebrospinal fluid leakage, indicating that more research is needed to establish safe and effective treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Optimize Spinal Cord Perfusion in Patients with Acute Traumatic Spinal Cord Injuries: A Systematic Review. Evaniew, N., Mazlouman, SJ., Belley-Côté, EP., et al.[2021]

In a study of 12 patients with severe traumatic spinal cord injury, increasing spinal cord perfusion pressure (SCPP) by about 20 mmHg led to varied responses in sensory evoked potentials (SEPs) and tissue metabolism, indicating that the effects can differ significantly among individuals.

The results suggest that monitoring SEP amplitude changes in response to SCPP can help tailor treatment for patients, as improvements in SEP amplitude were linked to better outcomes, highlighting the need for personalized management rather than a one-size-fits-all approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heterogeneous effect of increasing spinal cord perfusion pressure on sensory evoked potentials recorded from acutely injured human spinal cord. Gallagher, MJ., López, DM., Sheen, HV., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9486559/

Significance of spinal cord perfusion pressure following ... This scoping review systematically reviewed relevant research to summarize the literature addressing the significance of monitoring spinal cord perfusion ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0976566222002600

Significance of spinal cord perfusion pressure following ... This scoping review systematically reviewed relevant research to summarize the literature addressing the significance of monitoring spinal cord perfusion ...

3. e-neurospine.org e-neurospine.org/m/journal/view.php?number=1073

Hemodynamic Management of Acute Spinal Cord Injury As a result, 33%–60% and 88%–92% of complete and incomplete cord injury patients, respectively, recovered their neurologic outcome. Table 1.

4. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/37/5/article-p729.xml

Multimodal interventions to optimize spinal cord perfusion in ... SCPP can be improved by raising MAP with vasopressors or lowering intraspinal pressure with laminectomy and durotomy when dural compression is ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06451133

Hemodynamic Management Following Acute Traumatic ... The purpose of this study is to assess the effect of various hemodynamic management strategies on functional neurologic outcomes and non-neurologic adverse ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S187887501932474X

Clinical Implementation of Novel Spinal Cord Perfusion ... Here, we present results of the initial experience with implementation of an SCPP protocol to guide MAP management goals for acute SCI at a U.S. Level I trauma ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12528847/

Optimization of Spinal Cord Perfusion Pressure for ... Patients may benefit most from individualized management of SCPP because of the wide variance in interpatient and chronological intrathecal ...