CHASM: Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI

• Sponsor: University of British Columbia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04758377
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 24
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 27.8
• Patients Per Site Per Month: 0.9

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Traumatic Spinal Cord Haemorrhage	Procedure: Magnetic resonance imaging (MRI)	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI
• Actual Study Start Date: Feb 6, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.	Procedure: Magnetic resonance imaging (MRI); Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.

Outcome Measures

Primary Outcome Measures

1. Hemorrhage Quantification 1 [Serial MRI assessments: Injury to 2 weeks post injury]

   Area of hematoma

2. Hemorrhage Quantification 2 [Serial MRI assessments: Injury to 2 weeks post injury]

   Vertical length of hematoma and vertical length of cord edema

3. Hemorrhage Quantification 3 [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

4. Hemorrhage Quantification 4 [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.

Secondary Outcome Measures

1. Hemodynamic Management Assessment 1 [Injury to 2 weeks post injury]

   achieved mean arterial pressure

2. Hemodynamic Management Assessment 2 [Injury to 2 weeks post injury]

   vasopressor usage/dose

Other Outcome Measures

1. Neurologic Assessments [Injury to 6 months post injury]

   International Standards for Neurological Classification of SCI (ISNCSCI)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vancouver General Hospital	Vancouver	British Columbia	Canada

Sponsors and Collaborators

• University of British Columbia
• United States Department of Defense

Investigators

• Principal Investigator: Brian Kwon, MD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brian Kwon, Principal Investigator, University of British Columbia
• ClinicalTrials.gov Identifier: NCT04758377
• Other Study ID Numbers: H20-03585
• First Posted: Feb 17, 2021
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Brian Kwon, Principal Investigator, University of British Columbia: vasopressors; magnetic resonance imaging
• Additional relevant MeSH terms: Spinal Cord Injuries; Hemorrhage

Study Results

No Results Posted as of Feb 8, 2022