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

Trial Summary

What is the purpose of this trial?

This multicenter study will enroll 100 patients with acute traumatic cervical and thoracic SCI who have a lumbar intrathecal catheter inserted within 24 hours of their injury. The lumbar intrathecal catheter will be inserted pre-operatively for the measurement of ITP and the collection of cerebrospinal fluid (CSF) samples. SCPP will be calculated as the difference between MAP and the ITP. There are two important distinct yet related objectives in this prospective interventional study. 1. Determine the effect of SCPP maintenance ≥ 65 mmHg in acute SCI on neurologic recovery as measured by ASIA Impairment Scale (AIS) grade conversion and motor score improvement. 2. Collect CSF and blood samples for the measurement of neurochemical biomarkers and storage for future biomarker discovery and validation studies.

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 data supports the effectiveness of the treatment SCPP Management for Spinal Cord Injury?

Research suggests that managing spinal cord perfusion pressure (SCPP) can improve outcomes in spinal cord injuries by ensuring adequate blood flow to the spinal cord. Studies have shown that techniques like cerebrospinal fluid drainage can help increase SCPP, potentially leading to better recovery after injury. ^{1 2 3 4 5}

Is SCPP Management safe for humans?

SCPP Management has been studied for safety in people with spinal cord injuries. Some studies suggest it may improve recovery, but there are risks like heart-related issues and complications from monitoring techniques. More research is needed to fully understand its safety. ^{1 3 4 6 7}

How is SCPP Management treatment different from other treatments for spinal cord injury?

SCPP Management is unique because it focuses on maintaining spinal cord perfusion pressure (SCPP) to improve outcomes after spinal cord injury, rather than just targeting mean arterial pressure (MAP). This approach aims to ensure adequate blood flow to the spinal cord, which is crucial for recovery, and involves techniques like cerebrospinal fluid drainage to optimize pressure. ^{1 2 3 4 5}

Research Team

Brian Kwon, MD, PhD

Principal Investigator

University of British Columbia, Faculty of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Direct spinal cord perfusion pressure monitoring in extensive distal aortic aneurysm repair. [2022]

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

Cerebrospinal Fluid Drainage in Patients with Acute Spinal Cord Injury: A Multi-Center Randomized Controlled Trial. [2023]

3. United States 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. [2020]

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

Heterogeneous effect of increasing spinal cord perfusion pressure on sensory evoked potentials recorded from acutely injured human spinal cord. [2021]

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

Multimodal interventions to optimize spinal cord perfusion in patients with acute traumatic spinal cord injuries: a systematic review. [2022]

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

Interventions to Optimize Spinal Cord Perfusion in Patients with Acute Traumatic Spinal Cord Injuries: A Systematic Review. [2021]

7. England 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. [2023]