The PseAn Study - Study Protocol

Abdominal Trauma Clinical Trial

— PseAn  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627908
• Other study ID #: S_09_11_21_5555
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Niguarda Hospital
• Contact: Francesco Virdis, MD
• Phone: +393519639712
• Email: francesco.virdis[@]ospedaleniguarda.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Abdominal Injuries
• Abdominal Trauma
• Wounds and Injuries

Intervention

Other:
• Contrast-enhanced ultrasound
Patients data monitoring with medium- and high-grade trauma to the liver, spleen, and kidney

Locations

Country	Name	City	State
Italy	ASST GOM Niguarda	Milano	Italia

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

Outcome

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