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SCPP Management for Spinal Cord Injury (CASPER Trial)

N/A

Recruiting

Led By Brian Kwon, MD, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Blunt (non-penetrating) spinal cord injury treated either surgically or non-surgically

Complete (AIS A) or incomplete (AIS B, C) acute traumatic spinal cord injury

Must not have

Isolated radiculopathy

Pre-existing neurodegenerative disorder, such as Parkinson's disease, Alzheimer's disease, Huntington's disease, multiple sclerosis, amyotrophic lateral sclerosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will enroll 100 patients with recent, acute spinal cord injury. A lumbar intrathecal catheter will be inserted to measure intrathecal pressure and collect cerebrospinal fluid samples. The study's primary objective is to determine the effect of maintaining a systolic cerebrospinal perfusion pressure of 65 mmHg or greater on neurological recovery in patients with acute spinal cord injury, as measured by ASIA Impairment Scale grade conversion and motor score improvement.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include risks associated with lumbar intrathecal catheter insertion such as infection, bleeding, headache or nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have a recent spinal cord injury, either complete or incomplete.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have nerve pain from a single spinal nerve.

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

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

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I am currently pregnant.

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I don't have injuries that could affect the study's results.

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I have an autoimmune disorder like rheumatoid arthritis or lupus.

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I have a blood clotting disorder like hemophilia or von Willebrand disease.

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I have an injury near where a spine catheter would go.

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I have a spinal cord injury caused by a penetrating object.

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I have some control over my muscles below my spinal injury.

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I have a spinal cord injury that affects feeling but not movement.

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I do not have any major health issues like heart disease or HIV that could affect my safety in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination

Secondary study objectives

Levels of specific biochemical markers in CSF and Blood

Spinal Cord Perfusion Pressure (SCPP)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SCP Pressure ManagementExperimental Treatment1 Intervention

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

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,481 Previous Clinical Trials

2,494,816 Total Patients Enrolled

Rick Hansen InstituteOTHER

9 Previous Clinical Trials

665 Total Patients Enrolled

Brian Kwon, MD, PhD4.023 ReviewsPrincipal Investigator - University of British Columbia, Faculty of Medicine

University of British Columbia

1Patient Review

I was extremely disappointed with the level of customer service. I felt as though my concerns were dismissed and that the physician only wanted to talk about his successes.