NCT05627908

The PseAn Study - Study Protocol

Detection of Post-traumatic Abdominal Pseudoaneurysms by CEUS and CT: A Prospective Comparative Global Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 385 (estimated)
• Sponsor: Niguarda Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Abdominal Trauma
• Follow-up in Abdominal Trauma

Interventions

Type	Name	Description
OTHER	Contrast-enhanced ultrasound	Patients data monitoring with medium- and high-grade trauma to the liver, spleen, and kidney

Timeline

• Start date: 2022-10-01
• Primary completion: 2026-10-31
• Completion: 2027-12-31
• First posted: 2022-11-28
• Last updated: 2026-04-16

Locations

1 site across 1 country: Italy