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

Primary Purpose

Traumatic Spinal Cord Haemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Magnetic resonance imaging (MRI)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Traumatic Spinal Cord Haemorrhage focused on measuring vasopressors, magnetic resonance imaging

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.

Outcomes

Primary Outcome Measures

Hemorrhage Quantification 1
Area of hematoma
Hemorrhage Quantification 2
Vertical length of hematoma and vertical length of cord edema
Hemorrhage Quantification 3
The point of maximum cord compression vertebral level and anatomic point of maximum cord compression vertebral sublevel
Hemorrhage Quantification 4
Vertical length of cord edema rostral to maximum compression and vertical length of cord edema caudal to maximum compression.

Secondary Outcome Measures

Hemodynamic Management Assessment 1
achieved mean arterial pressure
Hemodynamic Management Assessment 2
vasopressor usage/dose

Full Information

First Posted
February 12, 2021
Last Updated
June 30, 2023
Sponsor
University of British Columbia
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04758377
Brief Title
Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI
Acronym
CHASM
Official Title
Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Spinal Cord Haemorrhage
Keywords
vasopressors, magnetic resonance imaging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.
Intervention Type
Procedure
Intervention Name(s)
Magnetic resonance imaging (MRI)
Intervention Description
Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.
Primary Outcome Measure Information:
Title
Hemorrhage Quantification 1
Description
Area of hematoma
Time Frame
Serial MRI assessments: Injury to 2 weeks post injury
Title
Hemorrhage Quantification 2
Description
Vertical length of hematoma and vertical length of cord edema
Time Frame
Serial MRI assessments: Injury to 2 weeks post injury
Title
Hemorrhage Quantification 3
Description
The point of maximum cord compression vertebral level and anatomic point of maximum cord compression vertebral sublevel
Time Frame
Serial MRI assessments: Injury to 2 weeks post injury
Title
Hemorrhage Quantification 4
Description
Vertical length of cord edema rostral to maximum compression and vertical length of cord edema caudal to maximum compression.
Time Frame
Serial MRI assessments: Injury to 2 weeks post injury
Secondary Outcome Measure Information:
Title
Hemodynamic Management Assessment 1
Description
achieved mean arterial pressure
Time Frame
Injury to 2 weeks post injury
Title
Hemodynamic Management Assessment 2
Description
vasopressor usage/dose
Time Frame
Injury to 2 weeks post injury
Other Pre-specified Outcome Measures:
Title
Neurologic Assessments
Description
International Standards for Neurological Classification of SCI (ISNCSCI)
Time Frame
Injury to 6 months post injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allan Aludino
Phone
604-875-4111
Ext
61689
Email
allan.aludino@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Kwon, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allan Aludino
Phone
604-875-4111
Ext
61689

12. IPD Sharing Statement

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Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI

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