NCT06942091

Brief 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). 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

15 years

First QC Date

April 13, 2025

Last Update Submit

April 21, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Presence of Shock

    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

    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 Outcomes (4)

  • Amount of Transfusion Administered

    Within 24 hours of hospital admission

  • In-hospital Morbidity

    Through hospital discharge, a median length of 17 days

  • In-hospital Mortality

    Up to hospital discharge, a median length of 17 days

  • ICU Length of Stay

    Through ICU stay during index hospitalization, a median length of 3 days

Study Arms (1)

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

Other: Traumatic Brain Injury (TBI)

Interventions

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.

TBI Group/non-TBI Group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult trauma patients underwent surgically confirmed blunt bowel and mesenteric injuries.

You may qualify if:

  • 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

You may not qualify if:

  • Isolated gastric, duodenal, or rectal injuries
  • Pediatric patients (\<16 years)
  • Incomplete or missing clinical records
  • Penetrating trauma
  • Patients who did not undergo surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, TraumaticShock

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

April 13, 2025

First Posted

April 24, 2025

Study Start

January 1, 2009

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 24, 2025

Record last verified: 2025-04