Novel STAR Score in Prediction of Intra-Abdominal Injury in Adult Blunt Abdominal Trauma PatientsNCT07286617
The Role of Novel STAR Score in Intra-Abdominal Injury in Adult Blunt Abdominal Trauma Patients
An observational study of Novel STAR Score in Prediction of Intra-Abdominal Injury in Adult Blunt Abdominal Trauma Patients, run by Assiut University.
Trial summary
This study aim To develop and assess the diagnostic accuracy of the novel STAR score, combining point-of-care abdominal ultrasound and laboratory parameters, for early prediction of intra-abdominal injuries in adult blunt abdominal trauma patients, and to compare its performance with current standard clinical… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Novel STAR Score in Prediction of Intra-Abdominal Injury in Adult Blunt Abdominal Trauma Patients
- What is being tested?
- STAR Score
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- Adult
Study population: Adult patients aged 18-60 years presenting to the Emergency Department with blunt abdominal trauma within 6 hours of injury. Eligible patients include both hemodynamically stable and unstable individuals, provided they have a Glasgow Coma Scale (GCS) of 15/15 at presentation. Patients with penetrating trauma, prior abdominal pathology, pregnancy, infection, hematuria, those requiring cardiopulmonary resuscitation, or on mechanical ventilation at initial assessment will be excluded.
Who may be able to join
- Adults aged 18 to 60 years with a documented history of blunt abdominal trauma. Presentation within 6 hours of sustaining the injury.
- Hemodynamically stable or unstable patients at the time of presentation:
- Stable: Normal blood pressure and heart rate, warm extremities, and capillary refill ≤2 seconds Unstable: Systolic blood pressure <90/60 mmHg or a decrease of >30% from baseline systolic pressure, heart rate >100 beats per minute, cold, clammy skin, and capillary refill time >2 seconds..
- Glasgow Coma Scale (GCS) score of 15/15 on initial assessment.
Who cannot join
- Patients with penetrating abdominal trauma.History of pre-existing abdominal pathology that may interfere with clinical or sonographic assessment (e.g., ascites, prior major abdominal surgery, known masses).
- Pregnant patients. Presence of pre-existing infection or hematuria that may alter laboratory parameters.
- Patients undergoing cardiopulmonary resuscitation upon arrival. Mechanically ventilated patients at the time of initial assessment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Role of Novel STAR Score in Prediction of Intra-Abdominal Injury in Adult Blunt Abdominal Trauma Patients
This study aim To develop and assess the diagnostic accuracy of the novel STAR score, combining point-of-care abdominal ultrasound and laboratory parameters, for early prediction of intra-abdominal injuries in adult blunt abdominal trauma patients, and to compare its performance with current standard clinical assessment methods
Read the detailed description
Blunt abdominal Injury(BAI) can cause damage to Internal organs and internal bleeding. The liver, spleen, and Intestine are the most common organs affected by this type of Injury, and due to the Indirect nature of this injury, diagnosis Is difficult and often time-consuming. Although the outcome of patients with blunt abdominal injury has improved in the last two decades, in patients with multiple organ injuries, the In-hospital mortality rate was reported as 3-10% Early recognition of abdominal trauma is critical, as missed or delayed diagnoses are associated with increased mortality. Clinical assessment, including history, inspection, palpation, percussion, and auscultation, forms the cornerstone of evaluation, but may be limited in accuracy, especially in unconscious or intoxicated patients The development of point-of-care imaging techniques, particularly Focused Assessment with Sonography for Trauma (FAST), has greatly enhanced rapid detection of free intraperitoneal fluid in unstable patients. As a non-invasive, bedside procedure Laboratory investigations play an important adjunctive role in the assessment of abdominal trauma
- Conditions
- Novel STAR Score in Prediction of Intra-Abdominal Injury in Adult Blunt Abdominal Trauma Patients
- Being tested
- STAR Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR ScoreDiagnostic test
The STAR (Screening Tool for Abdominal Injury Risk) score will be applied to adult patients with blunt abdominal trauma to predict intra-abdominal injuries. The score will be calculated based on clinical and laboratory parameters collected at presentation
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and validation of a novel ultrasound-laboratory-based scoring system capable of accurately predicting the presence of clinically significant intra-abdominal injury in adult patients with blunt abdominal trauma.
Measured: 7 days of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Novel STAR Score in Prediction of Intra-Abdominal Injury in Adult Blunt Abdominal Trauma PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed Osman Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286617
- Sponsor's protocol ID
- STAR-TRAUMA-2025-01
- Status last verified
- Dec 2025
- First submitted
- 30 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Novel STAR Score in Prediction of Intra-Abdominal Injury in Adult Blunt Abdominal Trauma Patients
- ClinicalTrials.gov ID
- NCT07286617
- Acronym / sponsor ID
- STAR-TRAUMA-2025-01
- Conditions
- Novel STAR Score in Prediction of Intra-Abdominal Injury in Adult Blunt Abdominal Trauma Patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 16 Dec 2025 (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.
This study aim To develop and assess the diagnostic accuracy of the novel STAR score, combining point-of-care abdominal ultrasound and laboratory parameters, for early prediction of intra-abdominal injuries in adult blunt abdominal trauma patients, and to compare its performance with current standard clinical assessment methods
Detailed description
Blunt abdominal Injury(BAI) can cause damage to Internal organs and internal bleeding. The liver, spleen, and Intestine are the most common organs affected by this type of Injury, and due to the Indirect nature of this injury, diagnosis Is difficult and often time-consuming. Although the outcome of patients with blunt abdominal injury has improved in the last two decades, in patients with multiple organ injuries, the In-hospital mortality rate was reported as 3-10% Early recognition of abdominal trauma is critical, as missed or delayed diagnoses are associated with increased mortality. Clinical assessment, including history, inspection, palpation, percussion, and auscultation, forms the cornerstone of evaluation, but may be limited in accuracy, especially in unconscious or intoxicated patients The development of point-of-care imaging techniques, particularly Focused Assessment with Sonography for Trauma (FAST), has greatly enhanced rapid detection of free intraperitoneal fluid in unstable patients. As a non-invasive, bedside procedure Laboratory investigations play an important adjunctive role in the assessment of abdominal trauma
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Adult patients aged 18-60 years presenting to the Emergency Department with blunt abdominal trauma within 6 hours of injury. Eligible patients include both hemodynamically stable and unstable individuals, provided they have a Glasgow Coma Scale (GCS) of 15/15 at presentation. Patients with penetrating trauma, prior abdominal pathology, pregnancy, infection, hematuria, those requiring cardiopulmonary resuscitation, or on mechanical ventilation at initial assessment will be excluded.
Key inclusion criteria (4 listed)
- Adults aged 18 to 60 years with a documented history of blunt abdominal trauma. Presentation within 6 hours of sustaining the injury.
- Stable: Normal blood pressure and heart rate, warm extremities, and capillary refill ≤2 seconds Unstable: Systolic blood pressure <90/60 mmHg or a decrease of >30% from baseline systolic pressure, heart rate >100 beats per minute, cold, clammy skin, and capillary refill time >2 seconds..
- Glasgow Coma Scale (GCS) score of 15/15 on initial assessment.
Key exclusion criteria (3 listed)
- Patients with penetrating abdominal trauma.History of pre-existing abdominal pathology that may interfere with clinical or sonographic assessment (e.g., ascites, prior major abdominal surgery, known masses).
- Pregnant patients. Presence of pre-existing infection or hematuria that may alter laboratory parameters.
- Patients undergoing cardiopulmonary resuscitation upon arrival. Mechanically ventilated patients at the time of initial assessment.
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 |
|---|---|---|
| STAR ScoreThe STAR (Screening Tool for Abdominal Injury Risk) score will be applied to adult patients with blunt abdominal trauma to predict intra-abdominal injuries. The score will be calculated based on clinical and laboratory parameters collected at presentation | Diagnostic test | – |
Primary outcome
Development and validation of a novel ultrasound-laboratory-based scoring system capable of accurately predicting the presence of clinically significant intra-abdominal injury in adult patients with blunt abdominal trauma.
Time frame: 7 days of admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Novel STAR Score in Prediction of Intra-Abdominal Injury in Adult Blunt Abdominal Trauma Patients, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Mohamed Osman Ali (01090409785, ashmohamedosman2030@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and validation of a novel ultrasound-laboratory-based scoring system capable of accurately predicting the presence of clinically significant intra-abdominal injury in adult patients with blunt abdominal trauma. (time frame: 7 days of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2025.