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

NCT ID: NCT07286617

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 129 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2027-12-15

Brief 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 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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

STAR Score

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Aya Mohamed Osman Ali

Resident Physician, Faculty of Medicine - Assiut University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Aya Mohamed Osman Ali

Role: CONTACT

ashmohamedosman2030@gmail.com

01090409785

Other Identifiers

STAR-TRAUMA-2025-01

Identifier Type: -

Identifier Source: org_study_id