The PseAn Study - Study Protocol

Recruiting

• Conditions: Abdominal Trauma; Follow-up in Abdominal Trauma
• Interventions: Other: Contrast-enhanced ultrasound

• Registration Number: NCT05627908
• Lead Sponsor: Niguarda Hospital

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

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

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-10-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

• 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

• minor to 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
abdominal trauma	Contrast-enhanced ultrasound	CEUS in detecting post-traumatic splenic, hepatic, and renal PAs

Primary Outcome Measures

Name	Time	Method
Pseudoaneursim (PA)	up to 5 days post patients admission	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%.

Trial Locations

Locations (1)

ASST GOM Niguarda; 🇮🇹 Milano, Italia, Italy