An observational study in Abdominal Trauma and Follow-up in Abdominal Trauma, sponsored by Niguarda Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Niguarda Hospital · Observational
The researchers aim to study the role of contrast ultrasound in detecting post-traumatic splenic, hepatic, and renal PAs compared with the gold standard of CT with intravenous contrast at different follow-up time points, and whether it can replace CT scan in the follow-up of solid organ injuries
Adult patients (18 years old and above) with proven blunt or penetrating splenic and/or liver and/or renal trauma as shown by a CT scan and classified according to the American Injury Scale American Association for Surgery (AAST) Organ Injury Scale (OIS) with OIS III and above will undergo a follow-up with both a CEUS and CT scan to detect post-traumatic parenchymal pseudoaneurysm within two to five days from injury. Follow-up over five days post-admission will be included if they were performed within the same hospitalization
adult patients (18 years old and above) with proven blunt or penetrating splenic and/or liver and/or renal trauma as shown by a CT scan and classified according to the American Injury Scale American Association for Surgery (AAST) Organ Injury Scale (OIS) will be included
Exclusion Criteria:
CEUS in detecting post-traumatic splenic, hepatic, and renal PAs
Other: Contrast-enhanced ultrasound
Patients data monitoring with medium- and high-grade trauma to the liver, spleen, and kidney
Pseudoaneursim (PA)
In each centre, the coordinator will collect epidemiological, clinical, and surgical data on a case report form (CRF) that will be completed through a questionnaire by accessing a protected database. The protocol for data collection is shown in appendix 1 (attached). The link for accessing the completion of the CRF will be sent by email, to the Main Lead of each participating centre. The main outcome will be the number of post-traumatic Pseudoaneurysms identified with CT scan and CEUS. The sample size for unknown populations has been derived according to the formula N= Z2 x p (1-p)/ e2, setting standard deviation (SD) at 50%, confidence interval at 95%, and Z-score at 1.65. The minimum sample size was 385 patients with a sampling error of ± 5%.
Time frame: up to 5 days post patients admission
Plan to share: No
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Niguarda Hospital