The PseAn Study - Study Protocol

NCT05627908 | Recruiting

• 1 other identifier: S_09_11_21_5555
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Abdominal Trauma; Follow-up in Abdominal Trauma

Keywords

trauma; CT scan; CEUS; follow up; abdominal pseudoaneurism

Outcome Measures

Primary Outcomes (1)

• 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%.

  up to 5 days post patients admission

Study Arms (1)

abdominal trauma

CEUS in detecting post-traumatic splenic, hepatic, and renal PAs

Other: Contrast-enhanced ultrasound

Interventions

Contrast-enhanced ultrasound OTHER

Patients data monitoring with medium- and high-grade trauma to the liver, spleen, and kidney

abdominal trauma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• minor to 18 years old

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST GOM Niguarda

Milan, Italia, 20162, Italy

RECRUITING

MeSH Terms

Conditions

Abdominal Injuries; Wounds and Injuries

Central Study Contacts

Francesco Virdis, MD

CONTACT

+393519639712; francesco.virdis@ospedaleniguarda.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 28, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)