Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI

Not Applicable

Recruiting

• Conditions: Traumatic Spinal Cord Haemorrhage
• Interventions: Procedure: Magnetic resonance imaging (MRI)

• Registration Number: NCT04758377
• Lead Sponsor: University of British Columbia

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).

Detailed Description

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

Study Timeline

• Study Start: 2021-02-06
• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-03
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Magnetic resonance imaging (MRI)	Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.

Primary Outcome Measures

Name	Time	Method
Hemorrhage Quantification 2	Serial MRI assessments: Injury to 2 weeks post injury	Vertical length of hematoma and vertical length of cord edema
Hemorrhage Quantification 1	Serial MRI assessments: Injury to 2 weeks post injury	Area of hematoma
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.
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

Secondary Outcome Measures

Name	Time	Method
Hemodynamic Management Assessment 1	Injury to 2 weeks post injury	achieved mean arterial pressure
Hemodynamic Management Assessment 2	Injury to 2 weeks post injury	vasopressor usage/dose

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada