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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI
- ClinicalTrials.gov ID
- NCT04758377
- Acronym / sponsor ID
- CHASM / H20-03585
- Conditions
- Traumatic Spinal Cord Haemorrhage
- Keywords
- vasopressors, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Study start
- 6 Feb 2021 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: Magnetic resonance imaging (MRI)Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imaging (MRI)Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage. | Procedure or surgery | Arm 1 |
Primary outcome
Hemorrhage Quantification 1
Time frame: Serial MRI assessments: Injury to 2 weeks post injury
Area of hematoma
Hemorrhage Quantification 2
Time frame: Serial MRI assessments: Injury to 2 weeks post injury
Vertical length of hematoma and vertical length of cord edema
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
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.
2 secondary outcomes
Hemodynamic Management Assessment 1
Time frame: Injury to 2 weeks post injury
Hemodynamic Management Assessment 2
Time frame: Injury to 2 weeks post injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Related trials for Traumatic Spinal Cord Haemorrhage
Recruiting
Neurologic Stem Cell Treatment Study
Neurologic Disorders, Nervous System Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Kwon, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorrhage Quantification 1 (time frame: Serial MRI assessments: Injury to 2 weeks post injury). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.