The PseAn Study - Study Protocol

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Abdominal Trauma, Follow-up in Abdominal Trauma

Intervention / Treatment
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* Other: Contrast-enhanced ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| abdominal trauma<br>CEUS in detecting post-traumatic splenic, hepatic, and renal PAs | Other: Contrast-enhanced ultrasound<br>* Patients data monitoring with medium- and high-grade trauma to the liver, spleen, and kidney<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trauma, CT scan, CEUS, follow up, abdominal pseudoaneurism