tSCI Contrast Enhanced Ultrasound Study

NCT04056988 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00003267
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Acute Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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

  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.

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

Study Arms (1)

Acute spinal cord injury patients to undergo contrast-enhanced

EXPERIMENTAL

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

Interventions

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.

Also known as: DEFINITY®

Acute spinal cord injury patients to undergo contrast-enhanced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Interventions

perflutren

Results Point of Contact

• Title: Amy Anderson BSN RN
• Organization: University of Washington

amya9@uw.edu

206-744-9364

Study Officials

• Christoph P Hofstetter, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine: Neurological Surgery

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: July 31, 2018
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Locations

US (1)