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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03357081
Acronym
CEUS
Enrollment
16
Registered
2017-11-29
Start date
2018-02-27
Completion date
2019-09-22
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematoma

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.

Interventions

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

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Contrast-pooling within the hematoma as a sign of active extravasation1 yearContrast outside of the blood vessel indicates ongoing bleeding

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026