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tSCI Contrast Enhanced Ultrasound Study

Primary Purpose

Acute Spinal Cord Injury

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Perflutren Lipid Microsphere
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Spinal Cord Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

>18 Male or Female Acute <72 hours spinal cord injury American Spinal Injury Association (ASIA) grade A to D Medically stable to undergo routine decompression and spinal realignment

Exclusion Criteria:

<18 years of age Not clinically stable for spinal surgery Traumatic Brain Injury

Sites / Locations

  • Harborview Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute spinal cord injury patients to undergo contrast-enhanced

Arm Description

Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound. 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 DEFINITY® contrast agent (1.5ml DEFINITY®/8.5ml saline) will be given. Continuous imaging will be obtained to record contrast inflow and washout.

Outcomes

Primary Outcome Measures

Use of CEUS to improve post operative outcomes in acute spinal cord injury
Contrast-enhanced ultrasound (CEUS) to determine decrease of blood flow in the spinal cord at the site of injury

Secondary Outcome Measures

Full Information

First Posted
August 12, 2019
Last Updated
August 12, 2019
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT04056988
Brief Title
tSCI Contrast Enhanced Ultrasound Study
Official Title
Utilizing Contrast-enhanced Ultrasound (CEUS) to Assess Critically Hypo Perfused Spinal Cord Tissue After Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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 hypo-perfusion of the spinal cord and exacerbates the severity of injury. This is also referred to as secondary injury. Thus, knowledge of spinal cord hypo-perfusion would allow the treating physician to optimize the hemodynamic condition of patient with acute spinal cord injury and potentially improve functional outcome. We plan to use contrast-enhanced ultrasound (CEUS) to determine decrease of 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 us to determine the efficacy of certain treatments in improving blood flow and patients suffering from tSCI.
Detailed Description
Patients presenting to the Harborview Emergency room with acute traumatic spinal cord injury (tSCI) will be recruited to undergo contrast-enhanced ultrasound (CEUS) during routine surgery for decompression and stabilization of their injury. Traumatic spinal cord injury (tSCI) develops in two phases. The primary injury is characterized by direct mechanical destruction of cells, nerve fibers and blood vessels. The secondary injury phase represents the downstream biological effects of the loss of blood flow in the injury center as well as significant hypoperfusion in the surrounding penumbral zone. This process is associated with cytotoxic spinal cord edema, which causes a rise of tissue pressure within the contused spinal cord. While experimental studies demonstrate that spinal cord tissue damage due to primary injury is often remarkably limited, the cascade of biochemical and molecular processes that comprise secondary injury often exacerbate and define the extent of injury to the patient. Accordingly, two routinely performed clinical treatment strategies aim to mitigate the effects of secondary injury by improving the local tissue perfusion of the contused spinal cord. First, surgical decompression of the spinal cord is recommended within 24 hours after injury, as it may improve functional outcome. Second, trauma guidelines recommend maintenance of the mean arterial blood pressure at 85 - 90 Hg for the first 7 days after acute spinal cord injury. Despite these interventions and a tremendous research effort to develop neuroprotective therapies targeting the hypoperfused "rescue-able" penumbral zone, there are no clinically efficacious techniques to improve functional outcome following tSCI. We believe that a lack of clinical biomarkers for hypoperfused "rescue-able" penumbral zone is a main road block for the development of novel therapeutic procedures and therapies. This motivates a search for a biomarker for tSCI that can guide surgical and critical care interventions. We seek to develop an ultrasound-based biomarker for tSCI that is sensitive to the underlying tissue pathology and predictive of clinical outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Spinal Cord Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute spinal cord injury patients to undergo contrast-enhanced
Arm Type
Experimental
Arm Description
Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound. 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 DEFINITY® contrast agent (1.5ml DEFINITY®/8.5ml saline) will be given. Continuous imaging will be obtained to record contrast inflow and washout.
Intervention Type
Drug
Intervention Name(s)
Perflutren Lipid Microsphere
Other Intervention Name(s)
DEFINITY®
Intervention Description
Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound.
Primary Outcome Measure Information:
Title
Use of CEUS to improve post operative outcomes in acute spinal cord injury
Description
Contrast-enhanced ultrasound (CEUS) to determine decrease of blood flow in the spinal cord at the site of injury
Time Frame
Intra-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 Male or Female Acute <72 hours spinal cord injury American Spinal Injury Association (ASIA) grade A to D Medically stable to undergo routine decompression and spinal realignment Exclusion Criteria: <18 years of age Not clinically stable for spinal surgery Traumatic Brain Injury
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy M Anderson, BSN RN
Phone
206-744-9364
Email
amya9@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph P Hofstetter, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Anderson
Phone
206-744-9364
Email
amya9@uw.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey G Ojemann, MD
First Name & Middle Initial & Last Name & Degree
Shahin Hakimian, MD
First Name & Middle Initial & Last Name & Degree
John Miller, MD, PHD
First Name & Middle Initial & Last Name & Degree
Mark Holmes, MD
First Name & Middle Initial & Last Name & Degree
Andrew Ko, MD

12. IPD Sharing Statement

Learn more about this trial

tSCI Contrast Enhanced Ultrasound Study

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