The BIG Score and In-Hospital Trauma Mortality

NCT06574464 | Completed DMC

• 1 other identifier: 2023-202
• Study Type: observational
• Target: 563
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Multiple Trauma; Injury Traumatic

Keywords

BIG score; revised trauma score; injury severity score; mortality; multiple trauma

Outcome Measures

Primary Outcomes (4)

• Predictive ability of BIG score for 28-day mortality

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

  From admission to 28 days

• Predictive ability of Glasgow coma scale for 28-day mortality

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

  From admission to 28 days

• Predictive ability of Revised Trauma Score for 28-day mortality

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

  From admission to 28 days

• Predictive ability of Injury Severity Score for 28-day mortality

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

  From admission to 28 days

Study Arms (2)

Survivors

Survivors were defined as patients who were still alive after 28 days of admission to the emergency department.

Other: BIG SCORE; Other: Glasgow coma scale; Other: Revised Trauma Score; Other: Injury Severity Score

Non-survivors

Non-survivors had passed away within 28 days of admission to the emergency department

Other: BIG SCORE; Other: Glasgow coma scale; Other: Revised Trauma Score; Other: Injury Severity Score

Interventions

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).

Non-survivors; Survivors

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.

Non-survivors; Survivors

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.

Non-survivors; Survivors

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.

Non-survivors; Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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. Our

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Fatih, 34265, Turkey (Türkiye)

Location

Related Publications (5)

• Hoke MH, Usul E, Ozkan S. Comparison of Trauma Severity Scores (ISS, NISS, RTS, BIG Score, and TRISS) in Multiple Trauma Patients. J Trauma Nurs. 2021 Apr-Jun 01;28(2):100-106. doi: 10.1097/JTN.0000000000000567.

  PMID: 33667204 RESULT

• Borgman MA, Maegele M, Wade CE, Blackbourne LH, Spinella PC. Pediatric trauma BIG score: predicting mortality in children after military and civilian trauma. Pediatrics. 2011 Apr;127(4):e892-7. doi: 10.1542/peds.2010-2439. Epub 2011 Mar 21.

  PMID: 21422095 RESULT

• Brockamp T, Maegele M, Gaarder C, Goslings JC, Cohen MJ, Lefering R, Joosse P, Naess PA, Skaga NO, Groat T, Eaglestone S, Borgman MA, Spinella PC, Schreiber MA, Brohi K. Comparison of the predictive performance of the BIG, TRISS, and PS09 score in an adult trauma population derived from multiple international trauma registries. Crit Care. 2013 Jul 11;17(4):R134. doi: 10.1186/cc12813.

  PMID: 23844754 RESULT

• Park S, Wang IJ, Yeom SR, Park SW, Cho SJ, Yang WT, Tae W, Huh U, Song C, Kim Y, Park JH, Cho Y. Usefulness of the BIG Score in Predicting Massive Transfusion and In-Hospital Death in Adult Trauma Patients. Emerg Med Int. 2023 Oct 17;2023:5162050. doi: 10.1155/2023/5162050. eCollection 2023.

  PMID: 37881258 RESULT

• Az A, Sogut O, Ozcomlekci M, Dogan Y, Akdemir T. Predicting mortality in adults hospitalized with multiple trauma: Can the BIG score estimate risk? Ulus Travma Acil Cerrahi Derg. 2025 Jan;31(1):66-74. doi: 10.14744/tjtes.2024.92879.

  PMID: 39775514 DERIVED

MeSH Terms

Conditions

Multiple Trauma; Wounds and Injuries

Interventions

Glasgow Coma Scale; Injury Severity Score

Intervention Hierarchy (Ancestors)

Trauma Severity Indices; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Adem Az, M.D.

  Haseki Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 28, 2024
• Study Start: January 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)