Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI

Traumatic Spinal Cord Haemorrhage Clinical Trial

— CHASM  

Official title:

Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758377
• Other study ID #: H20-03585
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2023
• Source: University of British Columbia
• Contact: Allan Aludino
• Phone: 604-875-4111
• Email: allan.aludino[@]vch.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Spinal Cord Injuries
• Traumatic Spinal Cord Haemorrhage

Intervention

Procedure:
• Magnetic resonance imaging (MRI)
Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	United States Department of Defense

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurologic Assessments	International Standards for Neurological Classification of SCI (ISNCSCI)	Injury to 6 months post injury
Primary	Hemorrhage Quantification 1	Area of hematoma	Serial MRI assessments: Injury to 2 weeks post injury
Primary	Hemorrhage Quantification 2	Vertical length of hematoma and vertical length of cord edema	Serial MRI assessments: Injury to 2 weeks post injury
Primary	Hemorrhage Quantification 3	The point of maximum cord compression vertebral level and anatomic point of maximum cord compression vertebral sublevel	Serial MRI assessments: Injury to 2 weeks post injury
Primary	Hemorrhage Quantification 4	Vertical length of cord edema rostral to maximum compression and vertical length of cord edema caudal to maximum compression.	Serial MRI assessments: Injury to 2 weeks post injury
Secondary	Hemodynamic Management Assessment 1	achieved mean arterial pressure	Injury to 2 weeks post injury
Secondary	Hemodynamic Management Assessment 2	vasopressor usage/dose	Injury to 2 weeks post injury