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Completed

NCT Number: NCT06574464

The BIG Score and In-Hospital Trauma Mortality

This study investigated the efficacy and reliability of the BIG score, calculated based on the base deficit (BD), International Normalized Ratio (INR), and Glasgow coma scale (GCS), in comparison with the GCS, Revised trauma score (RTS), and Injury Severity Score (ISS) for predicting in-hospital mortality in adults with multiple-trauma presenting to the emergency department (ED).

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Key information

Conditions

Multiple Trauma Injury Traumatic Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haseki Training and Research Hospital

Istanbul, Fatih, 34265, Turkey (Türkiye)

About this study

This retrospective, observational, single-center study included 563 consecutive adults (≥ 18 years old) with multiple trauma who were admitted to our emergency department and hospitalized between January 2022 and December 2023. We assessed patient demographics (age and sex), vital signs on admission (systolic blood pressure [SBP, mmHg], heart rate [HR, beats/min], respiratory rate [RR, breaths/min], and peripheral oxygen saturation [SpO2, %]), complaints and symptoms on admission, anatomic region of injury, type of trauma (blunt or penetrating), mechanism of injury, BD measured in blood gases, INR, trauma scoring systems (e.g., GCS, RTS, ISS, and BIG score), and clinical outcomes (discharge, hospitalization, or death). The study cohort was divided into survivors and non-survivors. Survivors were defined as patients who were still alive after 28 days, while non-survivors had passed away within that time. The demographics, clinical characteristics, and trauma scoring systems were compared between survivors and non-survivors to determine the prognosis of patients with multiple trauma. Independent predictors of mortality were determined by multivariate logistic regression analysis of variables (demographic characteristics, clinical characteristics, and trauma scores) that differed significantly between survivors and non-survivors. Receiver operating characteristic (ROC) curve analysis was performed to establish cut-off values for the GCS, RTS, ISS, and BIG score, and then to assess the sensitivity and specificity of these scoring systems in terms of predicting in-hospital mortality.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • This study included 563 consecutive adults (≥ 18 years old) with multiple trauma who were admitted to our Emergency Department and hospitalized between January 2022 and December 2023.

Exclusion criteria

  • Patients aged < 18 years and adults who were discharged from the Emergency Department
  • Patients with non-traumatic injuries and those who presented to the Emergency Department for reasons other than trauma
  • Patients with missing Base Deficit and International Normalized Ratio levels
  • Patients who had been admitted to the hospital more than 24 hours after the trauma
  • Patients with single trauma (e.g., isolated extremity trauma, isolated head injury, etc.)
  • Patients with chronic conditions such as chronic renal failure or hepatic, hematological, or neurological diseases

Treatment and study plan

BIG SCORE

Other

The trauma BIG score is used to predict posttraumatic injury severity and mortality. It was originally designed for the pediatric population. The score is calculated using the Base Deficit (BD), International Normalized Ratio (INR), and Glasgow Coma Scale (GCS) score on admission using the following formula:

BIG score = (admission BD) + (2.5 × INR) + (15 - GCS).

Glasgow coma scale

Other

The Glasgow Coma Scale is a neurological assessment tool used to evaluate the level of consciousness of a patient. It assesses three items: eye-opening (spontaneous, 4 points; to verbal stimuli, 3 points; to pain stimuli, 2 points; no response, 1 point); verbal responses (oriented, 5 points; confused but coherent speech, 4 points; inappropriate words, 3 points; incomprehensible speech, 2 points; no response, 1 point); and motor responses (obeys commands, 6 points; localizes pain, 5 points; withdraws from pain, 4 points; flexes in response to pain, 3 points; extends in response to pain, 2 points; no response, 1 point). The total GCS score is obtained by summing the scores for the three items, and it ranges from 3 to 15.

Revised Trauma Score

Other

The Revised Trauma Score (RTS) is a physiological scoring system used to assess the severity of a traumatic injury. It considers three key parameters, Glasgow Coma Scale (GCS), Systolic Blood Pressure (SBP), and Respiratory Rate (RR), with a total score of 12 points. The study team retrospectively computed the RTS on admission by retrieving the GCS score, SBP, and RR per minute from the hospital's automated systems and archives.

Injury Severity Score

Other

The Injury Severity Score (ISS) is an anatomical scoring system used to assess the severity of injuries sustained by trauma patients. It provides a numerical value based on the anatomical regions of the body affected by trauma and the severity of those injuries. The ISS is calculated by dividing the body into six regions: the head/neck, face, chest, abdomen/pelvis, extremities, and external. Each region is assigned a score ranging from 1 to 6, with 1 indicating minor injury and 6 indicating severe injury. The highest score from each region is squared and then the scores are summed to calculate the overall ISS.

Primary outcomes

  1. Predictive ability of BIG score for 28-day mortality

    Time frame: From admission to 28 days

    The investigators assessed the predictive ability of BIG score in determining 28-day mortality.

  2. Predictive ability of Glasgow coma scale for 28-day mortality

    Time frame: From admission to 28 days

    The investigators assessed the predictive ability of Glasgow coma scale in determining 28-day mortality.

  3. Predictive ability of Revised Trauma Score for 28-day mortality

    Time frame: From admission to 28 days

    The investigators assessed the predictive ability of Revised Trauma score in determining 28-day mortality.

  4. Predictive ability of Injury Severity Score for 28-day mortality

    Time frame: From admission to 28 days

    The investigators assessed the predictive ability of Injury Severity Score in determining 28-day mortality.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

Predicting Mortality in Adults Hospitalized With Multiple Trauma: Can the BIG Score Estimate Risk?

Acronym: BIGstd

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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