The Role of Novel STAR Score in Intra-Abdominal Injury in Adult Blunt Abdominal Trauma Patients

December 13, 2025 updated by: Aya Mohamed Osman Ali, Assiut University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
7 days of admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STAR-TRAUMA-2025-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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