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

June 30, 2023 updated by: Brian Kwon, University of British Columbia
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a single-center prospective observational study of patients with an acute cervical traumatic spinal cord injury

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Recruiting
        • Vancouver General Hospital
        • Contact:
          • Allan Aludino
          • Phone Number: 61689 604-875-4111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemorrhage Quantification 1
Time Frame: Serial MRI assessments: Injury to 2 weeks post injury
Area of hematoma
Serial MRI assessments: Injury to 2 weeks post injury
Hemorrhage Quantification 2
Time Frame: Serial MRI assessments: Injury to 2 weeks post injury
Vertical length of hematoma and vertical length of cord edema
Serial MRI assessments: Injury to 2 weeks post injury
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
Serial MRI assessments: Injury to 2 weeks post injury
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.
Serial MRI assessments: Injury to 2 weeks post injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic Management Assessment 1
Time Frame: Injury to 2 weeks post injury
achieved mean arterial pressure
Injury to 2 weeks post injury
Hemodynamic Management Assessment 2
Time Frame: Injury to 2 weeks post injury
vasopressor usage/dose
Injury to 2 weeks post injury

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurologic Assessments
Time Frame: Injury to 6 months post injury
International Standards for Neurological Classification of SCI (ISNCSCI)
Injury to 6 months post injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Brian Kwon, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H20-03585

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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