The Canadian Multicentre CSF Monitoring and Biomarker Study

NCT01279811 | Completed DMC

• 1 other identifier: H10-01091
• Study Type: interventional
• Target: 86
• Locations: 2 countries
• Sites: 6

Brief Summary

The purpose of this study is to:

1. 1.Measure the pressure in the spinal fluid surrounding the spinal cord to find out how well the spinal cord is being supplied with blood.
2. 2.Determine how drugs called "vasopressors", which are used to control blood pressure following SCI (spinal cord injury), influence spinal fluid pressure.
3. 3.Characterize the severity of an SCI using the levels of specific proteins found within the spinal fluid.
4. 4.Predict how much neurologic recovery may be regained using the levels of specific proteins within your spinal fluid.
5. 5.Identify proteins within the spinal fluid that will help us learn more about what is happening after SCI and assist us in developing new treatments for SCI.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury, CSF, biomarkers, CSF pressure

Outcome Measures

Primary Outcomes (1)

• Spinal cord perfusion pressure

  SCPP will be calculated as the difference between the MAP and ITP. The ITP and MAP will be recorded over 5 days(5-7 days post-injury) while the lumbar intrathecal catheter is in place.

  5 days

Secondary Outcomes (3)

• Levels of specific biochemical markers in the CSF

  5 days

• International Standards for Neurological Classification of Spinal Cord Injury (aka ASIA Examination)

  1 year

• DN4 and other pain questionnaires

  1 year

Study Arms (1)

Single Arm

OTHER

Vasopressor Crossover - Dopamine \& NORepinephrine

Other: Crossover of vasopressors

Interventions

Crossover of vasopressors OTHER

To evaluate the effect of different vasopressor agents on SCPP, a "crossover" intervention will be conducted on patients requiring either NORepinephrine or DOPamine post-operatively, once daily for 5 days while the catheter is in place. A subject on NORepinephrine will be switched over to DOPamine for 1 hr, and then switched back to NORepinephrine. Likewise, a subject on DOPamine will be switched over to NORepinephrine for 1 hr, and then switched back to DOPamine. Subjects on both vasopressors will have DOPamine stopped for 1 hr and NORepinephrine titrated up to maintain the same MAP for 1 hr, and then brought back to the original levels of both vasopressors. On the following day, the reverse will be carried out, with a stoppage of the NORepinephrine and maintenance solely on DOPamine.

Also known as: vasopressors, DOPamine, NORepinephrine

Single Arm

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Complete (AIS A)or incomplete (AIS B, C) acute SCI involving bony spinal levels between C0 and L1
• Non-penetrating injury
• Able to communicate in English and provide informed consent
• Enrolled within 48 hours after injury and able to provide CSF and blood samples within this period

You may not qualify if:

• SCI that involves sensory impairment only (i.e., no impairment in ability to move arms and legs)
• Penetrating spinal cord injury
• Isolated radiculopathy (injury only to the nerve outside of the spinal cord)
• Cauda equina injury (injury to nerve roots at the end of the spinal cord)
• Severe injury to head at the time of the SCI
• Injury to lower back (below the spinal level L1)
• Major injury to legs, arms, pelvis, chest, or abdomen that make it impossible for doctors to tell how severely injured the spinal cord is
• Have a pre-existing neurological disorder such as Parkinson's disease, Alzheimer's disease, Huntington's disease, or multiple sclerosis or amyotrophic lateral sclerosis.
• Pre-existing thromboembolic disease or coagulopathy (disorders related to blood clotting), such as haemophilia or von Willebrand's disease
• Pre-existing and ongoing infection in the body (e.g., pneumonia, urinary tract infection, cellulitis)
• Pre-existing inflammatory or autoimmune disorder such as rheumatoid arthritis, systemic lupus, psoriasis
• Systemic disease that may interfere with safety or evaluation of the condition we're studying (e.g., heart disease, HIV, HTLV-1)
• Any other medical condition that in the investigator's opinion would render the study procedures dangerous or impair ability to receive study therapy
• Pregnancy

Sponsors & Collaborators

• University of British Columbia: lead
• Rick Hansen Institute: collaborator

Study Sites (6)

Zuckerberg San Francisco General Hospital (UCSF)

San Francisco, California, 94110, United States

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

London Health Science Centre- Victoria Campus

London, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Hôpital du Sacré-Coeur

Montreal, Quebec, Canada

Location

Related Publications (2)

• Stukas S, Cooper J, Gill J, Fallah N, Skinnider MA, Belanger L, Ritchie L, Tsang A, Dong K, Streijger F, Street J, Paquette S, Ailon T, Dea N, Charest-Morin R, Fisher CG, Bailey CS, Dhall S, Mac-Thiong JM, Wilson JR, Christie S, Dvorak MF, Wellington CL, Kwon BK. Association of CSF and Serum Neurofilament Light and Glial Fibrillary Acidic Protein, Injury Severity, and Outcome in Spinal Cord Injury. Neurology. 2023 Mar 21;100(12):e1221-e1233. doi: 10.1212/WNL.0000000000206744. Epub 2023 Jan 4.

  PMID: 36599698 DERIVED

• Rosner J, Negraeff M, Belanger LM, Tsang A, Ritchie L, Mac-Thiong JM, Christie S, Wilson JR, Dhall S, Charest-Morin R, Street J, Ailon T, Paquette S, Dea N, Fisher CG, Dvorak MF, Finnerup NB, Kwon BK, Kramer JLK. Characterization of Hyperacute Neuropathic Pain after Spinal Cord Injury: A Prospective Study. J Pain. 2022 Jan;23(1):89-97. doi: 10.1016/j.jpain.2021.06.013. Epub 2021 Jul 21.

  PMID: 34302956 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Vasoconstrictor Agents; Dopamine; Norepinephrine

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Ethanolamines; Amino Alcohols; Alcohols

Study Officials

• Brian K. Kwon, MD,PhD

  University of British Columbia and Vancouver General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 19, 2011
• Study Start: January 1, 2012
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

US (1); CA (5)