Trauma SplenicNCT04934384
The Role of Prehospital eFAST in Accelerating Time to Diagnostics or Definitive Treatment in the Emergency Department
An observational study of Trauma Splenic and Trauma Abdomen, run by Azienda Usl di Bologna at 1 site in Italy.
Trial summary
Actual literature has demonstrated that prehospital extended focused assessment sonography for trauma (eFAST) could impact on logistic and treatment decisions such as mode of transportation and choice of hospital destination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Splenic, Trauma Abdomen, Liver Injury
- What is being tested?
- prehospital extended focused assessment sonography for trauma
- How many people
- 199 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jun 2021to 26 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will involve all the patients admitted to the Maggiore Hospital's emergency department (ED) from January 2014 to December 2019 with a traumatic liver or spleen injury who survived enough time to get a CT scan or a surgical intervention within 3 hours from the ED admission
Who may be able to join
- Patients admitted to emergency department with a ICD-9-CM diagnosis of traumatic liver or spleen injury (codes 8640x, 8641x, 8650x, 8651x)
- Abdominal AIS ≥ 2
- CT scan or operating theatre admission performed within 180 minutes from ED admission
Who cannot join
- Death before CT scan or OR/Angio suite admission (missing primary outcome measure)
- Transferred to other hospitals before CT scan or operating room admission
- Missing data
Trial locations and contacts
1 site in 1 country.
Italy1 site
Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna
Bologna, 40110
About this study
Actual literature has demonstrated that prehospital extended focused assessment sonography for trauma (eFAST) could impact on logistic and treatment decisions such as mode of transportation and choice of hospital destination.
However, there are no data with regard to in-hospital effects of a positive prehospital eFAST.
Read more
The main objective of this study was to evaluate the effects of prehospital eFAST driven decisions on in hospital time-to-definitive diagnostics or time-to definitive treatment, whichever came first, in a level 1 trauma center.
The goal is to define if this information could have a role in prioritizing patients' access to care in a population of abdominal trauma patients with A-AIS > 1 and a documented liver or spleen injury.
- Conditions
- Trauma Splenic, Trauma Abdomen, Liver Injury
- Being tested
- prehospital extended focused assessment sonography for trauma
- Keywords
- trauma, liver, spleen
- Medical subject headings
- Abdominal Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prehospital extended focused assessment sonography for traumaDiagnostic test
Also called eFAST
Sonographic procedure performed in the prehospital environment aiming at evaluating peritoneal free fluid in trauma patients
| Study group | Role | What they receive |
|---|---|---|
| Positive prehospital eFAST | Patients with a positive prehospital eFAST, independently from their hemodynamic status or other vital signs Receives: Diagnostic Test: prehospital extended focused assessment sonography for trauma | |
| Negative or not performed prehospital eFAST | Patients with a positive prehospital eFAST, independently from their hemodynamic status or other vital signs Receives: Diagnostic Test: prehospital extended focused assessment sonography for trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to definitive diagnostics or treatment
Time from the ED arrival to CT scan imaging or surgical intervention (whichever came first)
Measured: 180 minutes
Secondary outcomes (2)
Prehospital time
Time from EMS dispatch to ED arrival
Measured: 240 minutes
Sensitivity and specificity of prehospital eFAST
Sensitivity and specificity of prehospital eFAST calculated considering ED eFAST as the gold standard measure
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start25 Jun 2021
- Primary completion15 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Trauma SplenicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934384
- Sponsor's protocol ID
- PreH-eFAST
- Status last verified
- Jul 2021
- First submitted
- 14 Jun 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Botker MT, Jacobsen L, Rudolph SS, Knudsen L. The role of point of care ultrasound in prehospital critical care: a systematic review. Scand J Trauma Resusc Emerg Med. 2018 Jun 26;26(1):51. doi: 10.1186/s13049-018-0518-x.
PubMed 29940990Chang R, Kerby JD, Kalkwarf KJ, Van Belle G, Fox EE, Cotton BA, Cohen MJ, Schreiber MA, Brasel K, Bulger EM, Inaba K, Rizoli S, Podbielski JM, Wade CE, Holcomb JB; PROPPR Study Group. Earlier time to hemostasis is associated with decreased mortality and rate of complications: Results from the Pragmatic Randomized Optimal Platelet and Plasma Ratio trial. J Trauma Acute Care Surg. 2019 Aug;87(2):342-349. doi: 10.1097/TA.0000000000002263.
PubMed 31349348Clarke JR, Trooskin SZ, Doshi PJ, Greenwald L, Mode CJ. Time to laparotomy for intra-abdominal bleeding from trauma does affect survival for delays up to 90 minutes. J Trauma. 2002 Mar;52(3):420-5. doi: 10.1097/00005373-200203000-00002.
PubMed 11901314El Zahran T, El Sayed MJ. Prehospital Ultrasound in Trauma: A Review of Current and Potential Future Clinical Applications. J Emerg Trauma Shock. 2018 Jan-Mar;11(1):4-9. doi: 10.4103/JETS.JETS_117_17.
PubMed 29628662Jorgensen H, Jensen CH, Dirks J. Does prehospital ultrasound improve treatment of the trauma patient? A systematic review. Eur J Emerg Med. 2010 Oct;17(5):249-53. doi: 10.1097/MEJ.0b013e328336adce.
PubMed 20124905
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Prehospital eFAST in Accelerating Time to Diagnostics or Definitive Treatment in the Emergency Department
- ClinicalTrials.gov ID
- NCT04934384
- Acronym / sponsor ID
- PreH-eFAST
- Conditions
- Trauma Splenic, Trauma Abdomen, Liver Injury
- Keywords
- trauma, liver, spleen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Actual literature has demonstrated that prehospital extended focused assessment sonography for trauma (eFAST) could impact on logistic and treatment decisions such as mode of transportation and choice of hospital destination.
However, there are no data with regard to in-hospital effects of a positive prehospital eFAST.
The main objective of this study was to evaluate the effects of prehospital eFAST driven decisions on in hospital time-to-definitive diagnostics or time-to definitive treatment, whichever came first, in a level 1 trauma center.
The goal is to define if this information could have a role in prioritizing patients' access to care in a population of abdominal trauma patients with A-AIS > 1 and a documented liver or spleen injury.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive prehospital eFAST | – | Diagnostic Test: prehospital extended focused assessment sonography for traumaPatients with a positive prehospital eFAST, independently from their hemodynamic status or other vital signs |
| Negative or not performed prehospital eFAST | – | Diagnostic Test: prehospital extended focused assessment sonography for traumaPatients with a positive prehospital eFAST, independently from their hemodynamic status or other vital signs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve all the patients admitted to the Maggiore Hospital's emergency department (ED) from January 2014 to December 2019 with a traumatic liver or spleen injury who survived enough time to get a CT scan or a surgical intervention within 3 hours from the ED admission
Key inclusion criteria (3 listed)
- Patients admitted to emergency department with a ICD-9-CM diagnosis of traumatic liver or spleen injury (codes 8640x, 8641x, 8650x, 8651x)
- Abdominal AIS ≥ 2
- CT scan or operating theatre admission performed within 180 minutes from ED admission
Key exclusion criteria (3 listed)
- Death before CT scan or OR/Angio suite admission (missing primary outcome measure)
- Transferred to other hospitals before CT scan or operating room admission
- Missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prehospital extended focused assessment sonography for traumaAlso: eFASTSonographic procedure performed in the prehospital environment aiming at evaluating peritoneal free fluid in trauma patients | Diagnostic test | Negative or not performed prehospital eFAST, Positive prehospital eFAST |
Primary outcome
Time to definitive diagnostics or treatment
Time frame: 180 minutes
Time from the ED arrival to CT scan imaging or surgical intervention (whichever came first)
2 secondary outcomes
Prehospital time
Time frame: 240 minutes
Sensitivity and specificity of prehospital eFAST
Time frame: 240 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Background: PubMed 29940990Botker MT, Jacobsen L, Rudolph SS, Knudsen L. The role of point of care ultrasound in prehospital critical care: a systematic review. Scand J Trauma Resusc Emerg Med. 2018 Jun 26;26(1):51. doi: 10.1186/s13049-018-0518-x.
- Background: PubMed 31349348Chang R, Kerby JD, Kalkwarf KJ, Van Belle G, Fox EE, Cotton BA, Cohen MJ, Schreiber MA, Brasel K, Bulger EM, Inaba K, Rizoli S, Podbielski JM, Wade CE, Holcomb JB; PROPPR Study Group. Earlier time to hemostasis is associated with decreased mortality and rate of complications: Results from the Pragmatic Randomized Optimal Platelet and Plasma Ratio trial. J Trauma Acute Care Surg. 2019 Aug;87(2):342-349. doi: 10.1097/TA.0000000000002263.
- Background: PubMed 11901314Clarke JR, Trooskin SZ, Doshi PJ, Greenwald L, Mode CJ. Time to laparotomy for intra-abdominal bleeding from trauma does affect survival for delays up to 90 minutes. J Trauma. 2002 Mar;52(3):420-5. doi: 10.1097/00005373-200203000-00002.
- Background: PubMed 29628662El Zahran T, El Sayed MJ. Prehospital Ultrasound in Trauma: A Review of Current and Potential Future Clinical Applications. J Emerg Trauma Shock. 2018 Jan-Mar;11(1):4-9. doi: 10.4103/JETS.JETS_117_17.
- Background: PubMed 20124905Jorgensen H, Jensen CH, Dirks J. Does prehospital ultrasound improve treatment of the trauma patient? A systematic review. Eur J Emerg Med. 2010 Oct;17(5):249-53. doi: 10.1097/MEJ.0b013e328336adce.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Splenic and Trauma Abdomen, run by Azienda Usl di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to definitive diagnostics or treatment (time frame: 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04934384, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.