tSCI Contrast Enhanced Ultrasound Study

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 the 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 patients with acute spinal cord injury and potentially improve functional outcomes. The investigators plan to use contrast-enhanced ultrasound (CEUS) to determine the 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 the investigators to determine the efficacy of certain treatments in improving blood flow and patients suffering from tSCI.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Spinal Cord Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

About this study

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 in 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 outcomes. Second, trauma guidelines recommend the 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 outcomes following tSCI. The investigators believe that a lack of clinical biomarkers for the hypoperfused "rescue-able" penumbral zone is the main roadblock to 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. The investigators seek to develop an ultrasound-based biomarker for tSCI that is sensitive to the underlying tissue pathology and predictive of clinical outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

>18
Male or Female
Acute <72 hours spinal cord injury (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
Known sensitivity to lipid microsphere or its components i.e., (PEG).
A history of anaphylactoid reactions from ultrasound-enhancing agents

Treatment and study plan

Perflutren Lipid Microsphere

Drug

Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound.

Other names: DEFINITY®

Primary outcomes

Feasibility of Intraoperative Contrast-enhanced Ultrasound in Acute Traumatic Spinal Cord Injury - Number of Participants With Successful Intraoperative Contrast-enhanced Ultrasound in Acute Traumatic Spinal Cord Injury

Time frame: Operative period to one-week or hospital discharge (first occurring event)

Feasibility was defined as successful intravenous administration of perflutren lipid microsphere contrast agent and acquisition of interpretable intraoperative contrast-enhanced ultrasound (CEUS) perfusion imaging during spinal decompressive surgery in patients with acute traumatic spinal cord injury.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Utilizing Contrast-enhanced Ultrasound (CEUS) to Assess Critically Hypo Perfused Spinal Cord Tissue After Injury

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2023
First posted: Aug 14, 2019
Registry last updated: Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed