The PseAn Study - Study Protocol
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNiguarda Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
minor to 18 years old
Trial population
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
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Contrast-enhanced ultrasound
Other interventionPatients data monitoring with medium- and high-grade trauma to the liver, spleen, and kidney
Treatment groups
385 Participants
are divided into 1 treatment groupGroup A: abdominal trauma1 intervention
Trial outcomes
Primary outcomes
1
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%.
Time frame
up to 5 days post patients admissionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov