Clinical trial NCT06574464: The BIG Score and In-Hospital Trauma Mortality
Official title: Predicting Mortality in Adults Hospitalized With Multiple Trauma: Can the BIG Score Estimate Risk?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Trauma
Injury Traumatic
Keywords: BIG score
revised trauma score
injury severity score
mortality
multiple trauma
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 563
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictive ability of BIG score for 28-day mortality
timeFrame: From admission to 28 days
measure: Predictive ability of Glasgow coma scale for 28-day mortality
timeFrame: From admission to 28 days
measure: Predictive ability of Revised Trauma Score for 28-day mortality
timeFrame: From admission to 28 days
measure: Predictive ability of Injury Severity Score for 28-day mortality
timeFrame: From admission to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
state: Fatih
Study officials:
affiliation: Haseki Training and Research Hospital
name: Adem Az, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.