An observational study in Hematoma, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-01.
Sponsored by Mayo Clinic · Observational
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.
109 studies on the registry are indexed under Hematoma; 19 are open to participants now.
This study's enrollment of 16 is below the median of 113 across 21 observational studies indexed under Hematoma.
Browse Hematoma studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
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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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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Real time contrast enhanced ultrasound with Lumason. CEUS or Contrast enhanced Ultrasound
Also known as: Ultrasound, CEUS with Lumason
Contrast-pooling within the hematoma as a sign of active extravasation
Contrast outside of the blood vessel indicates ongoing bleeding
Time frame: 1 year
Plan to share: No — 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
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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