The BIG Score and In-Hospital Trauma Mortality

NCT ID: NCT06574464

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

563 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-01-01

Brief Summary

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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

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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.

Conditions

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Multiple Trauma Injury Traumatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Survivors

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

BIG SCORE

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

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

BIG SCORE

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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BIG SCORE

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).

Intervention Type OTHER

Glasgow coma scale

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.

Intervention Type OTHER

Revised Trauma Score

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.

Intervention Type OTHER

Injury Severity Score

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haseki Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Adem Az

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adem Az, M.D.

Role: PRINCIPAL_INVESTIGATOR

Haseki Training and Research Hospital

Locations

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Haseki Training and Research Hospital

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 33667204 (View on PubMed)

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.

Reference Type RESULT
PMID: 21422095 (View on PubMed)

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.

Reference Type RESULT
PMID: 23844754 (View on PubMed)

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.

Reference Type RESULT
PMID: 37881258 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39775514 (View on PubMed)

Other Identifiers

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2023-202

Identifier Type: -

Identifier Source: org_study_id

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