Abdominal Trauma Clinical Trial
— PseAnOfficial title:
Detection of Post-traumatic Abdominal Pseudoaneurysms by CEUS and CT: A Prospective Comparative Global Study
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
Status | Recruiting |
Enrollment | 385 |
Est. completion date | December 31, 2027 |
Est. primary completion date | October 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | ASST GOM Niguarda | Milano | Italia |
Lead Sponsor | Collaborator |
---|---|
Niguarda Hospital |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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