Statistical Analysis of Traumatic Brain Injury VictimsNCT05075239
Morbidity and Mortality in Solo Adult Traumatic Brain Injury Patients in Minia University Hospital
An observational study of Statistical Analysis of Traumatic Brain Injury Victims, run by Minia University at 1 site in Egypt.
Trial summary
Tracking post-traumatic brain injury sequale Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Statistical Analysis of Traumatic Brain Injury Victims
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2021to 15 Jan 2022
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: both sexes with individual neurotrauma
Who may be able to join
- Solo non penetrating neurotrauma victims
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Keywords
- neurotrauma, traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality and morbidity
number of deaths from neurotrauma
Measured: 4 weeks
Secondary outcomes (1)
prediction
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
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start15 Sep 2021
- Primary completion1 Jan 2022
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Statistical Analysis of Traumatic Brain Injury VictimsStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe 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
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075239
- Sponsor's protocol ID
- 411-9/2021
- Status last verified
- Feb 2022
- First submitted
- 29 Sep 2021
- Last updated
- 4 Feb 2022
- 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 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence Of Morbidity And Mortality After Isolated Traumatic Brain Injury In Adult Neuro-intensive Care Unit In Minia University Hospital
- ClinicalTrials.gov ID
- NCT05075239
- Acronym / sponsor ID
- 411-9/2021
- Keywords
- neurotrauma, traumatic brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 12 Oct 2021 (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.
Tracking post-traumatic brain injury sequale
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- both sexes with individual neurotrauma
Key inclusion criteria (1 listed)
- Solo non penetrating neurotrauma victims
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality and morbidity
Time frame: 4 weeks
number of deaths from neurotrauma
1 secondary outcome
prediction
Time frame: one week
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 4 Feb 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Statistical Analysis of Traumatic Brain Injury Victims, run by Minia University at 1 site in Egypt.
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 1 inclusion and 2 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 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
mortality and morbidity (time frame: 4 weeks). 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 4 Feb 2022.