- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05075239
Morbidity and Mortality in Solo Adult Traumatic Brain Injury Patients in Minia University Hospital
February 3, 2022 updated by: Mina Maher, Minia University
Incidence Of Morbidity And Mortality After Isolated Traumatic Brain Injury In Adult Neuro-intensive Care Unit In Minia University Hospital
Tracking post-traumatic brain injury sequale
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Minia, Egypt, 6115
- Maher Maher
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
both sexes with individual neurotrauma
Description
Inclusion Criteria:
- Solo non penetrating neurotrauma victims
Exclusion Criteria:
1- Penetrating head trauma. 2- Polytrauma patients. 3- Coexist of Psychiatric disorders or history of neuronal disorders. 4- Refusal of patient relatives to participate in the assignment. 5- Pregnant females with TBI. 6- Patients who died during 24 hours from admission to ICU . 7- Patients more than 65 years of age .
8- combined abdominal or orthopedic trauma.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mortality and morbidity
Time Frame: 4 weeks
|
number of deaths from neurotrauma
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
prediction
Time Frame: one week
|
to examine the predictors of outcome including age , gender , admission systolic blood pressure < 90 mmHg , GCS score ,APACHE II score ,lateralization of pupil , brain CT findings ,serum sodium &potassium ,mechanical ventilation and length of stay in ICU
|
one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2021
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
January 15, 2022
Study Registration Dates
First Submitted
September 29, 2021
First Submitted That Met QC Criteria
September 29, 2021
First Posted (Actual)
October 12, 2021
Study Record Updates
Last Update Posted (Actual)
February 4, 2022
Last Update Submitted That Met QC Criteria
February 3, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 411-9/2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.