Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI (NCT04758377) | Clinical Trial Compass
UnknownNot Applicable
Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI
Canada24 participantsStarted 2021-02-06
Plain-language 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).
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hemorrhage Quantification 1
Timeframe: Serial MRI assessments: Injury to 2 weeks post injury
2
Hemorrhage Quantification 2
Timeframe: Serial MRI assessments: Injury to 2 weeks post injury
3
Hemorrhage Quantification 3
Timeframe: Serial MRI assessments: Injury to 2 weeks post injury
4
Hemorrhage Quantification 4
Timeframe: Serial MRI assessments: Injury to 2 weeks post injury