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Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI (CHASM)

University of British Columbia logo

University of British Columbia

Status

Enrolling

Conditions

Traumatic Spinal Cord Haemorrhage

Treatments

Procedure: Magnetic resonance imaging (MRI)

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04758377
H20-03585

Details and patient eligibility

About

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).

Full description

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

Enrollment

24 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Allan Aludino

Data sourced from clinicaltrials.gov

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