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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEUS or Contrast enhanced Ultrasound | Drug | Real time contrast enhanced ultrasound with Lumason. CEUS or Contrast enhanced Ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contrast-pooling within the hematoma as a sign of active extravasation | Contrast outside of the blood vessel indicates ongoing bleeding | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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The patient's will be enrolled during the partcipants Emergency Department evaluation at St. Mary's Hospital, Rochester, MN.
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Kummer | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36731072 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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This pilot study will allow us to develop ultrasound scanning parameters and protocols. Successful preliminary data of this pilot study would allow our team to apply for extramural funding for a larger clinical trial to assess the diagnostic accuracy of CEUS in the evaluation of these hematomas
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| ID | Term |
|---|---|
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| D055585 |
| Physical Phenomena |