Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654804
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-26
Brief Title:
Contrast-enhanced Ultrasound in the Treatment of Acute Spinal Cord Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Contrast-Enhanced Ultrasound Biomarker for Prognostication and Guidance of Surgical Treatment in Acute Traumatic Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with traumatic spinal cord injury tSCI often suffer from spinal cord swelling inside the thecal sac which contains the spinal cord and surrounding fluid leading to increased pressure on the spinal cord tissue and decreased spinal cord blood flow at the site of injury The combination of increased pressure and decreased blood flow causes vascular hypoperfusion of the spinal cord and exacerbates the severity of injury This is also referred to as secondary injury Thus knowledge of spinal cord hypoperfusion would allow the treating physician to optimize the hemodynamic condition of the patient with acute spinal cord injury and potentially improve functional outcomes
Detailed Description:
The investigators plan to use contrast-enhanced ultrasound CEUS to determine a decrease in the blood flow in the spinal cord at the site of injury during the routine surgery that these patients require to decompress and stabilize their injured spine This may help the investigators to determine the efficacy of certain treatments in improving blood flow and patients suffering from traumatic spinal cord injury
Patients presenting to Harborview Medical Center with a diagnosis of traumatic spinal cord injury will be screened for participation Many of these patients require emergent or urgent surgery for decompression of the spinal cord and stabilization of the spine
The patient will be taken to the operating room as per routine After completion of the key elements of surgery namely posterior decompression and stabilization of the cervical or thoracic spinal cord CEUS will be performed Importantly the proposed trial does not prolong the time before surgical decompression and stabilization are accomplished Moreover it does not increase the invasiveness of the procedure as it is collected at the final stage of the routine procedure A hand-held intraoperative ultrasound probe will be used to collect sagittal images of the spinal cord centered above the spinal cord injury A bolus IV injection of the contrast agent will be given Continuous imaging will be obtained to record contrast inflow and washout
Post-operatively the participant will receive routine MRI imaging within one week health status permitting and one year
Patients presenting to Harborview Medical Center with a diagnosis of traumatic spinal cord injury will be screened for participation Many of these patients require emergent or urgent surgery for decompression of the spinal cord and stabilization of the spine
The patient will be taken to the operating room as per routine After completion of the key elements of surgery namely posterior decompression and stabilization of the cervical or thoracic spinal cord CEUS will be performed Importantly the proposed trial does not prolong the time before surgical decompression and stabilization are accomplished Moreover it does not increase the invasiveness of the procedure as it is collected at the final stage of the routine procedure A hand-held intraoperative ultrasound probe will be used to collect sagittal images of the spinal cord centered above the spinal cord injury A bolus IV injection of the contrast agent will be given Continuous imaging will be obtained to record contrast inflow and washout
Post-operatively the participant will receive routine MRI imaging within one week health status permitting and one year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None