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tSCI Contrast Enhanced Ultrasound Study

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ClinicalTrials.gov Identifier: NCT04056988
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Christoph Hofstetter, University of Washington

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Spinal Cord Injury Drug: Perflutren Lipid Microsphere Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Utilizing Contrast-enhanced Ultrasound (CEUS) to Assess Critically Hypo Perfused Spinal Cord Tissue After Injury
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Perflutren

Arms and Interventions
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Arm Intervention/treatment
Experimental: Acute spinal cord injury patients to undergo contrast-enhanced

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.

 Drug: Perflutren Lipid Microsphere
Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound.
Other Name: DEFINITY®


Outcome Measures
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Primary Outcome Measures :
  1. Use of CEUS to improve post operative outcomes in acute spinal cord injury [ Time Frame: Intra-operative ]
    Contrast-enhanced ultrasound (CEUS) to determine decrease of blood flow in the spinal cord at the site of injury


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056988


Contacts
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Contact: Amy M Anderson, BSN RN 206-744-9364 amya9@uw.edu

Locations
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United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Amy Anderson    206-744-9364    amya9@uw.edu   
Principal Investigator: Jeffrey G Ojemann, MD         
Sub-Investigator: Shahin Hakimian, MD         
Sub-Investigator: John Miller, MD, PHD         
Sub-Investigator: Mark Holmes, MD         
Sub-Investigator: Andrew Ko, MD         
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Christoph P Hofstetter, MD University of Washington
More Information
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Responsible Party: Christoph Hofstetter, Assistant Professor, School of Medicine: Neurological Surgery, University of Washington
ClinicalTrials.gov Identifier: NCT04056988    
Other Study ID Numbers: STUDY00003267
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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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
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries