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MRI Evaluation for Spinal Cord Injury (CHASM Trial)
N/A
Recruiting
Led By Brian Kwon, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Acute tSCI injury involving bony spinal levels between C0 and T1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up injury to 6 months post injury
Awards & highlights
CHASM Trial Summary
This trial will test whether drugs to raise blood pressure and prevent blood clots can improve outcomes for people with traumatic spinal cord injuries.
Who is the study for?
This trial is for adults aged 19 or older who have suffered a traumatic spinal cord injury between the base of the skull and top of the chest (C0-T1) and are admitted to the study site within a day. They must be able to consent and have certain levels of impairment. Those with MRI-incompatible devices, very high BMI, incomplete assessments, injuries from infection or cancer, or multiple severe injuries can't join.Check my eligibility
What is being tested?
The study uses MRI scans to see if treatments right after a spinal cord injury affect bleeding in the spine. It looks at two things: whether raising blood pressure with drugs (vasopressors) and preventing blood clots with anticoagulants influence hemorrhage during the first two weeks post-injury.See study design
What are the potential side effects?
MRI itself doesn't usually cause side effects but lying still in a scanner might be uncomfortable for some people. The focus here is on observing changes rather than direct side effects from interventions like vasopressors or anticoagulants.
CHASM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spinal injury is between the base of my skull and the top of my mid-back.
CHASM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ injury to 6 months post injury
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~injury to 6 months post injury
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hemorrhage Quantification 1
Hemorrhage Quantification 2
Hemorrhage Quantification 3
+1 moreSecondary outcome measures
Hemodynamic Management Assessment 1
Hemodynamic Management Assessment 2
Other outcome measures
Neurologic Assessments
CHASM Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic resonance imaging (MRI)
2019
Completed Phase 4
~1080
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,992 Total Patients Enrolled
United States Department of DefenseFED
863 Previous Clinical Trials
227,608 Total Patients Enrolled
Brian Kwon, MDPrincipal InvestigatorUniversity of British Columbia
3 Previous Clinical Trials
130 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a certain level of impairment as measured by the Asia Impairment Scale (AIS).You weigh too much and cannot fit inside the MRI scanner.I was admitted to the study site within a day of my injury.I have severe injuries making MRI transport risky.My spinal injury is between the base of my skull and the top of my mid-back.My spinal cord injury was caused by an infection.I have a broken bone caused by a disease or cancer.I am 19 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been enlisted in this research endeavor?
"Confirmed. Per the clinicaltrials.gov records, this clinical trial has been open for recruitment since February 6th 2021 and was last updated on February 7th 2022. 24 participants are needed to be recruited from 1 site location."
Answered by AI
Is enrollment currently open for this research endeavor?
"According to the clinicaltrials.gov listing, this study is currently in search of participants. It was first published on February 6th 2021 and underwent its most recent revision a year later on February 7th 2022."
Answered by AI
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