Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05138536
Other study ID # 024.TRA.2016.D
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 6, 2020
Est. completion date March 6, 2020

Study information

Verified date November 2021
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In high-volume trauma centers, multi-slice CT scanners have become the routine imaging modality for screening trauma patients due to their speed and accuracy. In trauma patients with no known neurologic deficits, diagnostic CT is often obtained though it remains unclear whether this affects management of the patient [1]. With the growing cost of health care, a careful look at the benefit and cost of CT is needed to determine how to best utilize this modality in the evaluation of trauma patients. HYPOTHESIS: In trauma patients with absence of neurologic defects, the addition of comprehensive CT does not change overall clinical management.


Description:

Objectives: The primary objective of this study is to determine the benefit of the CT scan in the clinical management or outcomes of the trauma patients with no neurologic deficits. Primary Outcome: Percentage of trauma patients with no known neurologic deficits who underwent a CT, any clinically impactful CT findings. Secondary Outcome: Percentage of benefits CT provides in clinical features, clinical outcomes, injury severity score, GCS, age, sex, ethnicity, cause of injury, mechanism of injury, hospital length of stay, operative vs. non-operative, discharge disposition, radilogy, pathology results and images, any additional morbidities, total cost, 30-day readmission rate, and morality. And when operation does occur, the types of operation and the resulting cost and length of stay.


Recruitment information / eligibility

Status Completed
Enrollment 510
Est. completion date March 6, 2020
Est. primary completion date March 6, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18-years-old - No localizing neurologic defect - Any cause or mechanism of injury - Comprehensive CT obtained Exclusion Criteria: • Any patients that are pregnant or breastfeeding

Study Design


Intervention

Procedure:
Pan-Computer Tomography
trauma centers use the pan-computed tomography (CT) scan (head, neck, chest, and abdomen/pelvis) for the evaluation of blunt trauma.

Locations

Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of trauma patients with no known neurologic deficits who underwent a CT the benefit of pan-CT with no neurologic deficits April 2006 - April 2016
Secondary Percentage of benefits CT provides in clinical features Clinical outcomes, injury severity score, GCS, age, sex, ethnicity, cause of injury, mechanism of injury, hospital length of stay, operative vs non-operative April 2006 - April 2016
See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Terminated NCT03781817 - Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures Phase 4
Completed NCT04342416 - Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women N/A
Recruiting NCT04856449 - DBT Skills Plus EMDR for BPD and Trauma N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Recruiting NCT04725721 - Testing FIRST in Youth Outpatient Psychotherapy N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT03696563 - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS N/A
Withdrawn NCT03249129 - Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Completed NCT02240732 - Surgical Tourniquets and Cerebral Emboli N/A
Completed NCT02227979 - Effects of PURPLE Cry Intervention N/A
Withdrawn NCT01169025 - Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT01475344 - Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC) Phase 1/Phase 2
Completed NCT03112304 - Child STEPS for Youth Mental Health in Maine Sustainability N/A
Completed NCT01201863 - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy Phase 4
Completed NCT01210417 - Trauma Heart to Arm Time N/A