Traumatic Brain InjuryNCT06942091
Impact of Traumatic Brain Injury on Hemodynamic Instability in Patients With Blunt Bowel and Mesenteric Injuries
An observational study of Traumatic Brain Injury and Blunt Abdominal Trauma, run by Chang Gung Memorial Hospital.
Trial summary
This retrospective cohort study aims to evaluate the impact of traumatic brain injury (TBI) on hemodynamic status in trauma patients with surgically confirmed blunt bowel and mesenteric injuries (BBMI). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Brain Injury, Blunt Abdominal Trauma, Hemodynamic Instability
- What is being tested?
- Traumatic Brain Injury (TBI)
- How many people
- 169 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 31 Dec 2023
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult trauma patients underwent surgically confirmed blunt bowel and mesenteric injuries.
Who may be able to join
- Adults aged >16 years
- Patients with surgically confirmed blunt bowel and/or mesenteric injuries (BBMI)
- Underwent therapeutic laparotomy
- Complete emergency department and operative records available
Who cannot join
- Isolated gastric, duodenal, or rectal injuries
- Pediatric patients (<16 years)
- Incomplete or missing clinical records
- Penetrating trauma
- Patients who did not undergo surgery
About this study
Official title: Impact of Traumatic Brain Injury on Concomitant Blunt Hollow Organ Injuries: A Retrospective Analysis of a Cohort of Blunt Bowel Mesenteric Injuries
This retrospective cohort study aims to evaluate the impact of traumatic brain injury (TBI) on hemodynamic status in trauma patients with surgically confirmed blunt bowel and mesenteric injuries (BBMI). A total of 169 adult patients treated at a Level I trauma center between 2009 and 2023 were analyzed and stratified based on the presence or absence of concomitant TBI. Clinical parameters such as shock, massive transfusion, transfusion requirements, morbidity, and mortality were compared. The study investigates whether TBI is an independent risk factor for acute hemodynamic instability in BBMI patients, with the goal of improving trauma care strategies and understanding the systemic effects of TBI, particularly through the lens of the brain-gut axis.
Read the detailed description
Patients Population We retrospectively reviewed patients with BBMI admitted to emergency department (ED) of Kaohsiung Chang Gung Memorial Hospital during the 15-year period January 1, 2009 to December 31, 2023 from the electronic medical record. Adult patients (age > 16 years of age) receiving therapeutic laparotomy for proven of BBMI were included in the study. Patient with isolated stomach, duodenal, or rectal injuries was excluded. Among these enrolled patients receiving brain computed tomography (CT) obtained at the ED, showing any type of intracerebral hemorrhage was defined as TBI (AIS ≥3). Patients were grouped according to the presence of intracerebral hemorrhage in the positive TBI versus negative TBI group. The two groups were compared, and associated injuries were assessed for their ability to predict the risk factors of presence of shock and receiving massive transfusion (MT), indicating of hemodynamic instability.
Study settings All trauma patients were treated according to the Advanced Trauma Life Support upon arrival to ED. Injury severity was calculated as Injury Severity Score (ISS) and New Injury Severity Score (NISS) based on the Abbreviated Injury Score (AIS) score[19]. Trauma Score Injury Severity Score (TRISS) was used for prediction of prognosis. Laboratory data including leukocyte and hemoglobin were measured from samples obtained at ED. The demographic data, injury mechanism, vital signs, and Glasgow Coma Scores up on arrival to ED were recorded. Regarding the clinical presentation, the procedures including receiving endotracheal tube intubation, and tube thoracostomy at the ED, and presence of shock episode which was defined as systolic blood pressure < 90 mmHg were recorded. The incidence of need of transfusion at ED and MT defined as receiving more than 10 units packed red blood cells (RBC) within 24 hours was recorded. The amount of transfused Pack RBC or fresh frozen plasma (FFP) at the ED, operative room (OR) or within the initial 24 hours was recorded as well. Operative findings including the incidence of isolated small bowel injury (defined as only small bowel injury including ischemia, rupture, serosa injury, or hematoma), isolated colon injury (defined as only colon injury), isolated mesentery injury (defined as only mesenteric injury), combined injury (defined as either small bowel or colon injury concomitant with mesenteric injury), and operative blood loss were recorded. The outcomes including morbidity, mortality regarding 24 hour mortality, bowel-related or exsanguinations related, and length of stay regarding intensive care unit (ICU) and hospitalization were recorded.
The development of post injury complications including sepsis, pneumonia, septic shock, unplanned ventilator, intraabdominal abscess, postoperative leakage, coagulopathy, acute renal failure, acidosis, urinary tract infection, stroke, pulmonary embolism, acute respiratory distress syndrome, pleural effusion, enterocutaneous fistula, wound infection, abdomen compartment syndrome, tracheostomy, extracorporeal membrane oxygenation (ECMO), return to the operating room, and hemodialysis, intestinal obstruction was registered and defined as morbidity.
Statistics The data were analyzed using IBM SPSS Statistics for Windows, version 20.0 (IBM Corp., Armonk, NY, USA). Continuous variables were reported as medians and interquartile ranges. Considering the potential impact of a small sample size on our statistical analysis, we treated the data as non-normally distributed. The Mann-Whitney U test was therefore employed to analyze these continuous variables. We used logistic regression to evaluate the independent impact of TBI on presence of shock and receiving MT in BBMI patients while controlling for age, sex and associated injuries. Given that patients had varying degrees and different associated injuries, we considered the associated injuries as the possible confounders instead of the ISS due to its nonspecific nature and inability to differentiate injury patterns. To analyze the temporal relationship of TBI between morbidity and mortality, Kaplan-Meier analysis was utilized, and the log-rank test was applied to compare the morbidity and mortality curves between the TBI(+) and TBI(-) groups. The threshold for statistical significance was set at p < 0.05.
- Conditions
- Traumatic Brain Injury, Blunt Abdominal Trauma, Hemodynamic Instability, Shock, Massive Transfusion
- Being tested
- Traumatic Brain Injury (TBI)
- Medical subject headings
- Brain Injuries, Traumatic, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traumatic Brain Injury (TBI)Other
Presence of TBI identified by intracerebral hemorrhage on brain computed tomography (CT) at emergency department; not actively assigned by investigators but used to stratify comparison groups.
| Study group | Role | What they receive |
|---|---|---|
| TBI Group/non-TBI Group | TBI Group: Patients with blunt bowel and mesenteric injury (BBMI) with concomitant traumatic brain injury (TBI) Non-TBI Group: Patients with blunt bowel and mesenteric injury (BBMI) without TBI Receives: Other: Traumatic Brain Injury (TBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Shock
Proportion of BBMI patients who experienced shock, defined as systolic blood pressure < 90 mmHg at the emergency department.
Measured: At Emergency Department (initial presentation)
Need for Massive Transfusion
Proportion of BBMI patients who received more than 10 units of packed red blood cells within 24 hours after arrival.
Measured: Within 24 hours of hospital admission
Secondary outcomes (4)
Amount of Transfusion Administered
Total number of packed red blood cell (PRBC) and fresh frozen plasma (FFP) units transfused within 24 hours.
Measured: Within 24 hours of hospital admission
In-hospital Morbidity
Proportion of patients developing at least one complication such as pneumonia, coagulopathy, acidosis, urinary tract infection, tracheostomy, etc.
Measured: Through hospital discharge, a median length of 17 days
In-hospital Mortality
All-cause mortality occurring during the index hospitalization.
Measured: Up to hospital discharge, a median length of 17 days
ICU Length of Stay
Duration of stay in the intensive care unit (ICU) in days.
Measured: Through ICU stay during index hospitalization, a median length of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Jan 2009
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shih-Chiang Hung, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942091
- Sponsor's protocol ID
- 201902275B0
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Traumatic Brain Injury on Concomitant Blunt Hollow Organ Injuries: A Retrospective Analysis of a Cohort of Blunt Bowel Mesenteric Injuries
- ClinicalTrials.gov ID
- NCT06942091
- Acronym / sponsor ID
- 201902275B0
- Conditions
- Traumatic Brain Injury, Blunt Abdominal Trauma, Hemodynamic Instability, Shock, Massive Transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Apr 2025 (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 retrospective cohort study aims to evaluate the impact of traumatic brain injury (TBI) on hemodynamic status in trauma patients with surgically confirmed blunt bowel and mesenteric injuries (BBMI). A total of 169 adult patients treated at a Level I trauma center between 2009 and 2023 were analyzed and stratified based on the presence or absence of concomitant TBI. Clinical parameters such as shock, massive transfusion, transfusion requirements, morbidity, and mortality were compared. The study investigates whether TBI is an independent risk factor for acute hemodynamic instability in BBMI patients, with the goal of improving trauma care strategies and understanding the systemic effects of TBI, particularly through the lens of the brain-gut axis.
Detailed description
Patients Population We retrospectively reviewed patients with BBMI admitted to emergency department (ED) of Kaohsiung Chang Gung Memorial Hospital during the 15-year period January 1, 2009 to December 31, 2023 from the electronic medical record. Adult patients (age > 16 years of age) receiving therapeutic laparotomy for proven of BBMI were included in the study. Patient with isolated stomach, duodenal, or rectal injuries was excluded. Among these enrolled patients receiving brain computed tomography (CT) obtained at the ED, showing any type of intracerebral hemorrhage was defined as TBI (AIS ≥3). Patients were grouped according to the presence of intracerebral hemorrhage in the positive TBI versus negative TBI group. The two groups were compared, and associated injuries were assessed for their ability to predict the risk factors of presence of shock and receiving massive transfusion (MT), indicating of hemodynamic instability.
Study settings All trauma patients were treated according to the Advanced Trauma Life Support upon arrival to ED. Injury severity was calculated as Injury Severity Score (ISS) and New Injury Severity Score (NISS) based on the Abbreviated Injury Score (AIS) score[19]. Trauma Score Injury Severity Score (TRISS) was used for prediction of prognosis. Laboratory data including leukocyte and hemoglobin were measured from samples obtained at ED. The demographic data, injury mechanism, vital signs, and Glasgow Coma Scores up on arrival to ED were recorded. Regarding the clinical presentation, the procedures including receiving endotracheal tube intubation, and tube thoracostomy at the ED, and presence of shock episode which was defined as systolic blood pressure < 90 mmHg were recorded. The incidence of need of transfusion at ED and MT defined as receiving more than 10 units packed red blood cells (RBC) within 24 hours was recorded. The amount of transfused Pack RBC or fresh frozen plasma (FFP) at the ED, operative room (OR) or within the initial 24 hours was recorded as well. Operative findings including the incidence of isolated small bowel injury (defined as only small bowel injury including ischemia, rupture, serosa injury, or hematoma), isolated colon injury (defined as only colon injury), isolated mesentery injury (defined as only mesenteric injury), combined injury (defined as either small bowel or colon injury concomitant with mesenteric injury), and operative blood loss were recorded. The outcomes including morbidity, mortality regarding 24 hour mortality, bowel-related or exsanguinations related, and length of stay regarding intensive care unit (ICU) and hospitalization were recorded.
The development of post injury complications including sepsis, pneumonia, septic shock, unplanned ventilator, intraabdominal abscess, postoperative leakage, coagulopathy, acute renal failure, acidosis, urinary tract infection, stroke, pulmonary embolism, acute respiratory distress syndrome, pleural effusion, enterocutaneous fistula, wound infection, abdomen compartment syndrome, tracheostomy, extracorporeal membrane oxygenation (ECMO), return to the operating room, and hemodialysis, intestinal obstruction was registered and defined as morbidity.
Statistics The data were analyzed using IBM SPSS Statistics for Windows, version 20.0 (IBM Corp., Armonk, NY, USA). Continuous variables were reported as medians and interquartile ranges. Considering the potential impact of a small sample size on our statistical analysis, we treated the data as non-normally distributed. The Mann-Whitney U test was therefore employed to analyze these continuous variables. We used logistic regression to evaluate the independent impact of TBI on presence of shock and receiving MT in BBMI patients while controlling for age, sex and associated injuries. Given that patients had varying degrees and different associated injuries, we considered the associated injuries as the possible confounders instead of the ISS due to its nonspecific nature and inability to differentiate injury patterns. To analyze the temporal relationship of TBI between morbidity and mortality, Kaplan-Meier analysis was utilized, and the log-rank test was applied to compare the morbidity and mortality curves between the TBI(+) and TBI(-) groups. The threshold for statistical significance was set at p < 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBI Group/non-TBI Group | – | Other: Traumatic Brain Injury (TBI)TBI Group: Patients with blunt bowel and mesenteric injury (BBMI) with concomitant traumatic brain injury (TBI) Non-TBI Group: Patients with blunt bowel and mesenteric injury (BBMI) without TBI |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult trauma patients underwent surgically confirmed blunt bowel and mesenteric injuries.
Key inclusion criteria (4 listed)
- Adults aged >16 years
- Patients with surgically confirmed blunt bowel and/or mesenteric injuries (BBMI)
- Underwent therapeutic laparotomy
- Complete emergency department and operative records available
Key exclusion criteria (5 listed)
- Isolated gastric, duodenal, or rectal injuries
- Pediatric patients (<16 years)
- Incomplete or missing clinical records
- Penetrating trauma
- Patients who did not undergo surgery
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 |
|---|---|---|
| Traumatic Brain Injury (TBI)Presence of TBI identified by intracerebral hemorrhage on brain computed tomography (CT) at emergency department; not actively assigned by investigators but used to stratify comparison groups. | Other | TBI Group/non-TBI Group |
Primary outcome
Presence of Shock
Time frame: At Emergency Department (initial presentation)
Proportion of BBMI patients who experienced shock, defined as systolic blood pressure < 90 mmHg at the emergency department.
Need for Massive Transfusion
Time frame: Within 24 hours of hospital admission
Proportion of BBMI patients who received more than 10 units of packed red blood cells within 24 hours after arrival.
4 secondary outcomes
Amount of Transfusion Administered
Time frame: Within 24 hours of hospital admission
In-hospital Morbidity
Time frame: Through hospital discharge, a median length of 17 days
In-hospital Mortality
Time frame: Up to hospital discharge, a median length of 17 days
ICU Length of Stay
Time frame: Through ICU stay during index hospitalization, a median length of 3 days
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 24 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Blunt Abdominal Trauma, run by Chang Gung Memorial Hospital.
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 4 inclusion and 5 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 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Presence of Shock (time frame: At Emergency Department (initial presentation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2025.