Multiple TraumaBIGstdNCT06574464
The BIG Score and In-Hospital Trauma Mortality
An observational study of Multiple Trauma and Injury Traumatic, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Trauma, Injury Traumatic
- What is being tested?
- BIG SCORE, Glasgow coma scale and Revised Trauma Score
- How many people
- 563 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Fatih, 34265
About this study
Official title: Predicting Mortality in Adults Hospitalized With Multiple Trauma: Can the BIG Score Estimate Risk?
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).
Read the 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.
- Conditions
- Multiple Trauma, Injury Traumatic
- Being tested
- BIG SCORE, Glasgow coma scale, Revised Trauma Score, Injury Severity Score
- Keywords
- BIG score, revised trauma score, injury severity score, mortality, multiple trauma
- Medical subject headings
- Multiple Trauma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIG SCOREOther
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 scaleOther
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 ScoreOther
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 ScoreOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Survivors | Survivors were defined as patients who were still alive after 28 days of admission to the emergency department. Receives: 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 Receives: Other: BIG SCORE; Other: Glasgow coma scale; Other: Revised Trauma Score; Other: Injury Severity Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive ability of BIG score for 28-day mortality
The investigators assessed the predictive ability of BIG score in determining 28-day mortality.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From admission to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Jan 2022
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adem Az, Haseki Training and Research Hospital
- Investigators
- Adem Az, M.D., Principal investigator, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574464
- Sponsor's protocol ID
- 2023-202
- Acronym
- BIGstd
- Status last verified
- Aug 2024
- First submitted
- 25 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Stored in non-publicly available Available on request
Publications
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.
PubMed 33667204Borgman 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.
PubMed 21422095Brockamp 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.
PubMed 23844754Park 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.
PubMed 37881258Az 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.
PubMed 39775514
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Mortality in Adults Hospitalized With Multiple Trauma: Can the BIG Score Estimate Risk?
- ClinicalTrials.gov ID
- NCT06574464
- Acronym / sponsor ID
- BIGstd / 2023-202
- Conditions
- Multiple Trauma, Injury Traumatic
- Keywords
- BIG score, revised trauma score, injury severity score, mortality, multiple trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Other: BIG SCORE, Other: Glasgow coma scale, Other: Revised Trauma Score, Other: Injury Severity ScoreSurvivors were defined as patients who were still alive after 28 days of admission to the emergency department. |
| Non-survivors | – | Other: BIG SCORE, Other: Glasgow coma scale, Other: Revised Trauma Score, Other: Injury Severity ScoreNon-survivors had passed away within 28 days of admission to the emergency department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIG SCOREThe 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). | Other | Non-survivors, Survivors |
| Glasgow coma scaleThe 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. | Other | Non-survivors, Survivors |
| Revised Trauma ScoreThe 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. | Other | Non-survivors, Survivors |
| Injury Severity ScoreThe 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. | Other | Non-survivors, Survivors |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Results publication: PubMed 33667204Hoke 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.
- Results publication: PubMed 21422095Borgman 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.
- Results publication: PubMed 23844754Brockamp 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.
- Results publication: PubMed 37881258Park 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.
- Derived from this study: PubMed 39775514Az 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.
- Individual participant dataSharing planned: No. Stored in non-publicly available Available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adem Az, M.D. principal investigator
Haseki Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Trauma and Injury Traumatic, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive ability of BIG score for 28-day mortality (time frame: From admission to 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06574464, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.