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The PseAn Study - Study Protocol

N

Niguarda Hospital

Status

Enrolling

Conditions

Follow-up in Abdominal Trauma
Abdominal Trauma

Treatments

Other: Contrast-enhanced ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT05627908
S_09_11_21_5555

Details and patient eligibility

About

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

Full 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

Enrollment

385 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

385 participants in 1 patient group

abdominal trauma
Description:
CEUS in detecting post-traumatic splenic, hepatic, and renal PAs
Treatment:
Other: Contrast-enhanced ultrasound

Trial contacts and locations

1

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Central trial contact

Francesco Virdis, MD

Data sourced from clinicaltrials.gov

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