Traumatic Spinal Cord HaemorrhageCHASMNCT04758377
Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI
A study testing Magnetic resonance imaging (MRI) in people with Traumatic Spinal Cord Haemorrhage, run by University of British Columbia at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Traumatic Spinal Cord Haemorrhage
- What is being tested?
- Magnetic resonance imaging (MRI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 6 Feb 2021to 15 Dec 2025
- Phase
- Interventional
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
This will be a single-center prospective observational study of patients with an acute cervical traumatic spinal cord injury
- Conditions
- Traumatic Spinal Cord Haemorrhage
- Being tested
- Magnetic resonance imaging (MRI)
- Keywords
- vasopressors, magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Procedure or surgery
Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage. Receives: Procedure: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhage Quantification 1
Area of hematoma
Measured: Serial MRI assessments: Injury to 2 weeks post injury
Hemorrhage Quantification 2
Vertical length of hematoma and vertical length of cord edema
Measured: Serial MRI assessments: Injury to 2 weeks post injury
Hemorrhage Quantification 3
The point of maximum cord compression vertebral level and anatomic point of maximum cord compression vertebral sublevel
Measured: Serial MRI assessments: Injury to 2 weeks post injury
Hemorrhage Quantification 4
Vertical length of cord edema rostral to maximum compression and vertical length of cord edema caudal to maximum compression.
Measured: Serial MRI assessments: Injury to 2 weeks post injury
Secondary outcomes (2)
Hemodynamic Management Assessment 1
achieved mean arterial pressure
Measured: Injury to 2 weeks post injury
Hemodynamic Management Assessment 2
vasopressor usage/dose
Measured: Injury to 2 weeks post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start6 Feb 2021
- Primary completion3 Jul 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Spinal Cord HaemorrhageStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Brian Kwon, University of British Columbia
- Investigators
- Brian Kwon, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758377
- Sponsor's protocol ID
- H20-03585
- Other IDs
- CDMRP-SC190120
- Acronym
- CHASM
- Status last verified
- Jun 2023
- First submitted
- 12 Feb 2021
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No