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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-27

Study Completion Date

2019-09-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Hematoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

CEUS or Contrast enhanced Ultrasound

Intervention Type DRUG

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

Interventions

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CEUS or Contrast enhanced Ultrasound

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

Intervention Type DRUG

Other Intervention Names

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Ultrasound CEUS with Lumason

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes