Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI

NCT04758377 | Unknown DMC

• 1 other identifier: H20-03585
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Spinal Cord Haemorrhage

Keywords

vasopressors; magnetic resonance imaging

Outcome Measures

Primary Outcomes (4)

• Hemorrhage Quantification 1

  Area of hematoma

  Serial MRI assessments: Injury to 2 weeks post injury

• Hemorrhage Quantification 2

  Vertical length of hematoma and vertical length of cord edema

  Serial MRI assessments: Injury to 2 weeks post injury

• 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

• 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 Outcomes (2)

• Hemodynamic Management Assessment 1

  Injury to 2 weeks post injury

• Hemodynamic Management Assessment 2

  Injury to 2 weeks post injury

Other Outcomes (1)

• Neurologic Assessments

  Injury to 6 months post injury

Study Arms (1)

Arm 1

EXPERIMENTAL

Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.

Procedure: Magnetic resonance imaging (MRI)

Interventions

Magnetic resonance imaging (MRI) PROCEDURE

Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.

Arm 1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• United States Department of Defense: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Brian Kwon, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan Aludino

CONTACT

604-875-4111; allan.aludino@vch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: February 6, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CA (1)