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

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: Not yet recruiting
• Conditions: Novel STAR Score in Prediction of Intra-Abdominal Injury in Adult Blunt Abdominal Trauma Patients
• Intervention / Treatment: Diagnostic test: STAR Score

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: Observational
• Enrollment (Estimated): 129

Contacts and Locations

• Study Contact: Name: Aya Mohamed Osman Ali; Phone Number: 01090409785; Email: ashmohamedosman2030@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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.	7 days of admission

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID 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