The Canadian Multicentre CSF Monitoring and Biomarker Study

Drug

General health

Online since 10 July 2024, updated 204 days ago

About this trial

This is a trial to study the cerebrospinal fluid (CSF) surrounding the spinal cord of individuals with acute spinal cord injuries. The trial will find out how well the spinal cord is being supplied with blood and to find molecular indicators (markers) in the CSF that may predict nervous system recovery after SCI. The study will also look at how blood pressure drugs (vasopressors) influence spinal fluid pressure. Trial participants will have a thin, temporary tube (catheter) inserted into their lower back to access spinal cord fluid 3 times per day, for 5 days. A neurological exam will follow 3, 6, and 12 months after injury.

Included participants

Gender

All

Age

≥ 17 years

Injury level

C1 - L1

Severity (AIS)?

AIS-A

AIS-B

AIS-C

Time since injury

≤ 48 hours

Injury type

Traumatic

Healthy volunteers

C1-L1

What’s involved

Type

Drug

Details

A thin tube will be inserted into the lower back for 5 days from which CSF will be taken out every 8 hours, 3 times per day. Neurological examinations after 3, 6, and 12 months after the injury. The participant will receive specific drugs against low blood pressure (NORepinephrine and/or DOPamine) after their injury and will switch between these drugs at specific time-frames.

Potential benefits

Main benefits

General health

Additional benefits

Pain

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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