An observational study in Multiple Trauma and Injury Traumatic, sponsored by Haseki Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Haseki Training and Research Hospital · Observational
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).
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.
139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.
This study's enrollment of 563 is above the median of 200 across 84 observational studies indexed under Multiple Trauma.
Browse Multiple Trauma studies →Haseki Training and Research Hospital is the lead sponsor of 78 studies on the registry; 17 are open to participants now.
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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. Our
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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).
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.
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.
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.
Predictive ability of BIG score for 28-day mortality
The investigators assessed the predictive ability of BIG score in determining 28-day mortality.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From admission to 28 days
Plan to share: No — Stored in non-publicly available Available on request
Ran from Jan 2022 to primary completion in Dec 2023, 23 months.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Haseki Training and Research Hospital