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Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI (CHASM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04758377
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : February 8, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Brian Kwon, University of British Columbia

Study Description
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Brief Summary:
The study is designed to determine whether hemorrhage within the injured spinal cord is influenced by mean arterial pressure (MAP) augmentation with vasopressors and by venous thromboembolism (VTE) prophylaxis with anticoagulants in the first two weeks following a traumatic spinal cord injury (tSCI).

Condition or disease Intervention/treatment Phase
Traumatic Spinal Cord Haemorrhage Procedure: Magnetic resonance imaging (MRI) Not Applicable

Detailed Description:
This will be a single-center prospective observational study of patients with an acute cervical traumatic spinal cord injury
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI
Actual Study Start Date : February 6, 2021
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.
 Procedure: Magnetic resonance imaging (MRI)
Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.


Outcome Measures
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Primary Outcome Measures :
  1. Hemorrhage Quantification 1 [ Time Frame: Serial MRI assessments: Injury to 2 weeks post injury ]
    Area of hematoma

  2. Hemorrhage Quantification 2 [ Time Frame: Serial MRI assessments: Injury to 2 weeks post injury ]
    Vertical length of hematoma and vertical length of cord edema

  3. Hemorrhage Quantification 3 [ Time Frame: Serial MRI assessments: Injury to 2 weeks post injury ]
    The point of maximum cord compression vertebral level and anatomic point of maximum cord compression vertebral sublevel

  4. Hemorrhage Quantification 4 [ Time Frame: Serial MRI assessments: Injury to 2 weeks post injury ]
    Vertical length of cord edema rostral to maximum compression and vertical length of cord edema caudal to maximum compression.


Secondary Outcome Measures :
  1. Hemodynamic Management Assessment 1 [ Time Frame: Injury to 2 weeks post injury ]
    achieved mean arterial pressure

  2. Hemodynamic Management Assessment 2 [ Time Frame: Injury to 2 weeks post injury ]
    vasopressor usage/dose


Other Outcome Measures:
  1. Neurologic Assessments [ Time Frame: Injury to 6 months post injury ]
    International Standards for Neurological Classification of SCI (ISNCSCI)


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute tSCI injury involving bony spinal levels between C0 and T1
  • Baseline Asia Impairment Scale (AIS) grade of A, B, or C
  • Admission to study site within 24 hours of injury
  • Male or female age 19 or older
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Pathological fracture due to metabolic condition or neoplasia
  • Spinal cord injury due to infection
  • Presence of pacemaker, aneurysm clip or other device which is a contraindication to MRI
  • BMI > 40 and unable to fit within the MRI scanner
  • Multiple life threatening injuries (ISS >16) that make transport to MRI not in the patient's best interest
  • Any condition that, at the time of admission, prevents a complete ISNCSCI assessment from being performed
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758377


Contacts
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Contact: Daniel Rogers 604-551-9847 daniel.rogers@ubc.ca

Locations
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Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Allan Aludino    604-875-4111 ext 61689      
Sponsors and Collaborators
University of British Columbia
United States Department of Defense
Investigators
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Principal Investigator: Brian Kwon, MD University of British Columbia
More Information
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Responsible Party: Brian Kwon, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT04758377    
Other Study ID Numbers: H20-03585
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Kwon, University of British Columbia:
vasopressors
magnetic resonance imaging
Additional relevant MeSH terms:
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Spinal Cord Injuries
Hemorrhage
Pathologic Processes
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries