- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06942091
Impact of Traumatic Brain Injury on Hemodynamic Instability in Patients With Blunt Bowel and Mesenteric Injuries
Impact of Traumatic Brain Injury on Concomitant Blunt Hollow Organ Injuries: A Retrospective Analysis of a Cohort of Blunt Bowel Mesenteric Injuries
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Isolated gastric, duodenal, or rectal injuries
- Pediatric patients (<16 years)
- Incomplete or missing clinical records
- Penetrating trauma
- Patients who did not undergo surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At Emergency Department (initial presentation)
|
|
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.
|
Within 24 hours of hospital admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of Transfusion Administered
Time Frame: Within 24 hours of hospital admission
|
Total number of packed red blood cell (PRBC) and fresh frozen plasma (FFP) units transfused within 24 hours.
|
Within 24 hours of hospital admission
|
|
In-hospital Morbidity
Time Frame: Through hospital discharge, a median length of 17 days
|
Proportion of patients developing at least one complication such as pneumonia, coagulopathy, acidosis, urinary tract infection, tracheostomy, etc.
|
Through hospital discharge, a median length of 17 days
|
|
In-hospital Mortality
Time Frame: Up to hospital discharge, a median length of 17 days
|
All-cause mortality occurring during the index hospitalization.
|
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
|
Duration of stay in the intensive care unit (ICU) in days.
|
Through ICU stay during index hospitalization, a median length of 3 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201902275B0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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