The Canadian Multicentre CSF Monitoring and Biomarker Study (CAMPER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of British Columbia
Sponsor:
Collaborator:
Rick Hansen Foundation
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01279811
First received: January 18, 2011
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.

Condition Intervention
Spinal Cord Injury
Other: Crossover of vasopressors

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Canadian Multicentre CSF Monitoring and Biomarker Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Spinal cord perfusion pressure [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Levels of specific biochemical markers in the CSF [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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.

  • International Standards for Neurological Classification of Spinal Cord Injury (aka ASIA Examination) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • DN4 and other pain questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Crossover of vasopressors
    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.
    Other Names:
    • vasopressors
    • DOPamine
    • NORepinephrine
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.
  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Receipt of investigational drug within 30 days of injury
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279811

Contacts
Contact: Daniel Rogers 604-707-2170 drogers@rickhanseninstitute.org

Locations
Canada, Alberta
Foothills Hospital Recruiting
Calgary, Alberta, Canada
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Principal Investigator: Brian K. Kwon, MD,PhD,FRCSC         
Canada, Nova Scotia
QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
London Health Science Centre- Victoria Campus Recruiting
London, Ontario, Canada
Canada, Quebec
Hôpital du Sacré-Coeur Recruiting
Montreal, Quebec, Canada
Sponsors and Collaborators
University of British Columbia
Rick Hansen Foundation
Investigators
Principal Investigator: Brian K. Kwon, MD,PhD,FRCSC University of British Columbia and Vancouver General Hospital
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01279811     History of Changes
Other Study ID Numbers: H10-01091
Study First Received: January 18, 2011
Last Updated: January 22, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
spinal cord injury, CSF, biomarkers, CSF pressure

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Dopamine
Norepinephrine
Dopamine Agents
Vasoconstrictor Agents
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on July 23, 2014