Traumatic Spinal Cord Haemorrhage
Conditions
Keywords
vasopressors, magnetic resonance imaging
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
Interventions
PROCEDUREMagnetic resonance imaging (MRI)
Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.
Sponsors
United States Department of Defense
University of British Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemorrhage Quantification 1 | Serial MRI assessments: Injury to 2 weeks post injury | Area of hematoma |
| Hemorrhage Quantification 2 | Serial MRI assessments: Injury to 2 weeks post injury | Vertical length of hematoma and vertical length of cord edema |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neurologic Assessments | Injury to 6 months post injury | International Standards for Neurological Classification of SCI (ISNCSCI) |
Countries
Canada
Contacts
Primary ContactAllan Aludino
Outcome results
None listed