Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI

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

Official Title
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Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI

Conditions
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Traumatic Spinal Cord Haemorrhage

Intervention / Treatment
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* Procedure: Magnetic resonance imaging (MRI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage. | Procedure: Magnetic resonance imaging (MRI)<br>* Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic Management Assessment 1 | achieved mean arterial pressure | Injury to 2 weeks post injury | 
| Hemodynamic Management Assessment 2 | vasopressor usage/dose | Injury to 2 weeks post injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vasopressors, magnetic resonance imaging