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

Hematoma Clinical Trial

— CEUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357081
• Other study ID #: 17-004506
• Status: Completed
• Start date: February 27, 2018
• Est. completion date: September 22, 2019

Study information

• Verified date: January 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 22, 2019
• Est. primary completion date: September 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematoma

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast-pooling within the hematoma as a sign of active extravasation	Contrast outside of the blood vessel indicates ongoing bleeding	1 year

External Links

•   Mayo Clinic Clinical Trials