Utility of Real-Time Contrast Enhanced Ultrasound (CEUS) in the Evaluation of Soft Tissue Hematomas

NCT03357081 | Completed FDA Drug

• 1 other identifier: 17-004506
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Traumatic and non-traumatic soft tissue hematomas are frequently encountered in the acute care setting. The incidence of these hematomas appears to be on the rise secondary to the increased use of anticoagulants among older patients for a variety of medical conditions. The management of soft tissue hematomas depends on the accurate diagnosis of any ongoing bleeding as well as of identification of the injured vessel type. While the majority of cases can be managed conservatively, expanding hematomas leading to hemodynamic instability or ongoing blood loss might require embolization or surgical intervention. The mainstay diagnostic imaging modality is multidetector computed tomography (MDCT) with intravenous contrast that allows accurate assessment of hematoma size, location as well as evaluation for active extravasation. However, many patients cannot undergo CT imaging due to underlying kidney disease, allergy to contrast, or due to concerns for radiation exposure, especially in young age. Currently there are no alternative tests for these patients with a similarly high diagnostic accuracy available. This study intends to establish an imaging protocol and investigate the utility of contrast-enhanced ultrasound (CEUS) in the diagnostic work-up of soft tissue hematoma as an ionizing radiation-free alternative to computed tomography (CT) that can be used independent from the kidney function of the patient.

Conditions

Hematoma

Outcome Measures

Primary Outcomes (1)

• Contrast-pooling within the hematoma as a sign of active extravasation

  Contrast outside of the blood vessel indicates ongoing bleeding

  1 year

Study Arms (1)

CEUS

Adult patients over the age of 18 who have a clinical suspicion of an actively bleeding soft-tissue hematoma as determined by the treating emergency provider. Enrollment will be for one year or until a target of 20 patients is enrolled.

Drug: CEUS or Contrast enhanced Ultrasound

Interventions

CEUS or Contrast enhanced Ultrasound DRUG

Real time contrast enhanced ultrasound with Lumason. CEUS or Contrast enhanced Ultrasound

Also known as: Ultrasound, CEUS with Lumason

CEUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient's will be enrolled during the partcipants Emergency Department evaluation at St. Mary's Hospital, Rochester, MN.

You may qualify if:

• Adult patients over the age of 18 who have a clinical suspicion of an actively bleeding soft-tissue hematoma as determined by the treating emergency provider. Enrollment will be for one year or until a target of 20 patients is enrolled.

You may not qualify if:

• The investigators will exclude persons under the age of eighteen, vulnerable populations (pregnant patients and prisoners), need for immediate procedural intervention and those with known hypersensitivity to sulfur hexafluoride lipid containing microspheres as well as those who have a soft-tissue hematomas that are in an unfavorable anatomical location for ultrasound imaging.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Kummer T, Mohn KJ, Bardwell AJ, Boyum JH. Evaluation of Soft-Tissue Hematomas With Real-Time, Contrast-Enhanced Ultrasound: A Pilot Study With Preliminary Findings. Ultrasound Q. 2023 Sep 1;39(3):179-185. doi: 10.1097/RUQ.0000000000000621.

  PMID: 36731072 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hematoma

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Tobias Kummer

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: November 29, 2017
• Study Start: February 27, 2018
• Primary Completion: September 22, 2019
• Study Completion: September 22, 2019
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)