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Spinal Cord InjuryCAMPERNCT01279811

The Canadian Multicentre CSF Monitoring and Biomarker Study

A study testing Crossover of vasopressors in people with Spinal Cord Injury, run by University of British Columbia at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to: 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. Determine how drugs called "vasopressors", which are used to control blood pressure following SCI (spinal cord injury), influence spinal fluid… Read more about this study

Who is it for?
Ages 17 years and older
Conditions the study is for
Spinal Cord Injury
What is being tested?
Crossover of vasopressors
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
6 sitesin 2 countries
Study dates
Jan 2012to 30 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 17 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

Who cannot join

  • 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)
Show all 14Show fewer
  • 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

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Canada5 sites

  • QEII Health Sciences Centre

    Halifax, Nova Scotia

  • London Health Science Centre- Victoria Campus

    London, Ontario

  • Hôpital du Sacré-Coeur

    Montreal, Quebec

  • St. Michael's Hospital

    Toronto, Ontario

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

United States1 site

  • Zuckerberg San Francisco General Hospital (UCSF)

    San Francisco, California, 94110

Other trials in United States

About this study

The purpose of this study is to:

  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. Determine how drugs called "vasopressors", which are used to control blood pressure following SCI (spinal cord injury), influence spinal fluid pressure.
  3. Characterize the severity of an SCI using the levels of specific proteins found within the spinal fluid.
  4. Predict how much neurologic recovery may be regained using the levels of specific proteins within your spinal fluid.
  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.
Read the detailed description

This research project consists of two complementary yet distinct initiatives:

  1. First, we will prospectively evaluate spinal cord perfusion pressure(SCPP)in patients with acute spinal cord injuries, to provide scientifically-based guidelines on the management of blood pressure during the acute injury phase.
  2. Second, we will evaluate cerebrospinal fluid(CSF) samples from these patients with the goal of prospectively validating a series of biochemical markers that correlate with injury severity and predict neurologic outcome. Ultimately, our goals are to enhance the neurologic outcome of individuals with spinal cord injuries by improving upon their acute clinical care, and to establish biological surrogates of injury severity that may be used to facilitate clinical trials of novel therapeutic interventions for acute spinal cord injury.

Specific Aims

This multicenter study will enroll patients with acute traumatic cervical and thoracic SCI within 48 hours of their injury. A lumbar intrathecal catheter will be inserted pre-operatively for the measurement of intrathecal pressure (ITP) and the collection of CSF samples. Spinal cord perfusion pressure will be calculated as the difference between mean arterial pressure (MAP) and the ITP. The objectives of this aspect of the study will be to:

  • Document the changes in SCPP over the first 5-7 days post-injury (with an intrathecal catheter that is in place for 5 days).
  • Determine the effect of different vasopressor agents on SCPP.

Additionally, CSF samples will be obtained from the intrathecal catheter at 8-hour intervals to analyse the expression of the following biochemical markers: including interleukin (IL)-6, IL-8, monocyte chemo-attractant protein (MCP)-1, glial fibrillary acidic protein (GFAP), S100beta, and tau. The objectives of this aspect of the study will be to:

  • Evaluate the accuracy of these inflammatory and neuronal markers at classifying the initial severity of paralysis and at predicting the extent of neurologic recovery.
  • Characterize the temporal pattern of expression of these proteins to provide a more complete description of the human pathophysiology of SCI.
Being tested
Crossover of vasopressors
Keywords
spinal cord injury, CSF, biomarkers, CSF pressure
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Crossover of vasopressorsOther

    Also called vasopressors, DOPamine, NORepinephrine

    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.

Study groups in NCT01279811
Study groupRoleWhat they receive
Single ArmOtherVasopressor Crossover - Dopamine \& NORepinephrine
Receives: Other: Crossover of vasopressors

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 days

Secondary outcomes (3)

  1. Levels of specific biochemical markers in the CSF

    CSF samples will be obtained from the intrathecal catheter at 8-hour intervals, three times daily for 5 days. These samples will be evaluated will the goal of prospectively validating a series of biochemical markers that correlate with injury severity and predict neurologic outcome.

    Measured: 5 days

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

    For the purposes of ensuring that neurologic deterioration is not occurring while the lumbar intrathecal catheter is in place, an ASIA assessment will be performed daily while the intrathecal catheter is inserted. For the purpose of documenting neurologic recovery over time, the ASIA examination will also be performed at 3, 6, and 12 months post-injury.

    Measured: 1 year

  3. DN4 and other pain questionnaires

    It is currently believed that the development of neuropathic pain is closely related to neuroinflammation after SCI. In an effort to determine if we could establish etiologic cytokines, we will administer the DN4 and other pain questionnaires to characterize and quantify neuropathic pain. These questionnaires will be administered at screening, days 1-5 post-insertion of the lumbar intrathecal catheter, 3 months, 6 months and 1 year post-injury.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2011 (estimated)
  2. Study startJan 2012
  3. Primary completion30 Sep 2020
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01279811
Sponsor's protocol ID
H10-01091
Acronym
CAMPER
Status last verified
Nov 2020
First submitted
18 Jan 2011
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36599698

  • 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.

    PubMed 34302956

Questions about this trial

What is this clinical trial studying?

A study testing Crossover of vasopressors in people with Spinal Cord Injury, run by University of British Columbia at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spinal cord perfusion pressure (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01279811, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.

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