Head TraumaNCT05386966
Medicolegal Aspects of Head Trauma
An observational study of Head Trauma, run by Sohag University at 1 site in Egypt.
Trial summary
Trauma is a critical global health problem. It represents the fifth leading cause of significant disability and is one of the most common causes of mortality in youth and adulthood, as one in 10 deaths worldwide occurred due to trauma. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Head Trauma
- What is being tested?
- questionnaire
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to Jun 2023
- 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 1 day and older
- All sexes
- Child, Adult, Older adult
Study population: Diagnosed cases of head trauma at Department of Neurosurgery
Who may be able to join
- Diagnosed cases of head trauma
Who cannot join
- Patients with deficient data i.e. escaped, discharged on demand before period of follow up
Trial locations and contacts
1 site in 1 country.
Maha A Hilal, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R Elshrif, professor
About this study
Official title: Medicolegal Aspects of Head Trauma in Sohag University Hospitals
Trauma is a critical global health problem. It represents the fifth leading cause of significant disability and is one of the most common causes of mortality in youth and adulthood, as one in 10 deaths worldwide occurred due to trauma.
The head is preferred target for criminal acts and is a favorite place for various pathological lesions .Traumatic head injury (THI)is one of the prevalent causes of global death and disability. lately, head injury (HI) cases have increased in both developed and developing nations. Therefore, it is of great value to evaluate the clinical and pathological features of head injury .
Read more
Every injury that results in harm to the scalp, skull or brain can be sort out as a HI which can be caused by traffic mishap, falls, sports and gunshot wounds. Vehicle accidents are one of the most prevalence causes of THI as they are deemed to be one of the main causes of fatality due to road-traffic accidents (RTA) .Among different type of the RTA, motorcycle accidents holds the number one cause of accident in most of the country .
Skull fracture and hemorrhage are common association, which may be present with head trauma and affect the outcome of the case.The skull fractures, especially by blunt force offer varying diagnostic and medico- legal problems to the medical jurists as well as to the clinicians.
- Conditions
- Head Trauma
- Being tested
- questionnaire
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Patient demographic data ( age, gender, residence , work ,Level of education) .Detailed history about the trauma (type, site , manner , mechanism of injury , actual cause of assault , post traumatic period till arrival to hospital ) .Clinical assessment ( Rapid neurological assessment , assesment of Scalp injury ,Presence of other body trauma ,Degree of severity of head injury according to GCS , Radiological finding. Treatment (Conservative or operative intervention ) .Follow up and outcome at the time of discharge by using the GOS .Expected time for healing (<20 day or >20 day ).Expectance for permanent infirmity
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of the current study is to assess and describe the change in the medicolegal aspects of traumatic head injuries in sohag university hospital
Expected time for healing and expectance for permanent infirmity
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Jul 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head TraumaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Gaber Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386966
- Sponsor's protocol ID
- Soh-Med-22-05-02
- Status last verified
- Jan 2023
- First submitted
- 18 May 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chelly H, Bahloul M, Ammar R, Dhouib A, Mahfoudh KB, Boudawara MZ, Chakroun O, Chabchoub I, Chaari A, Bouaziz M. Clinical characteristics and prognosis of traumatic head injury following road traffic accidents admitted in ICU "analysis of 694 cases". Eur J Trauma Emerg Surg. 2019 Apr;45(2):245-253. doi: 10.1007/s00068-017-0885-4. Epub 2017 Dec 12.
PubMed 29234838Wang J, Han F, Zhao Q, Xia B, Dai J, Wang Q, Huang S, Le C, Li Z, Liu J, Yang M, Wan C, Wang J. Clinicopathological Characteristics of Traumatic Head Injury in Juvenile, Middle-Aged and Elderly Individuals. Med Sci Monit. 2018 May 18;24:3256-3264. doi: 10.12659/MSM.908728.
PubMed 29773781Pearn ML, Niesman IR, Egawa J, Sawada A, Almenar-Queralt A, Shah SB, Duckworth JL, Head BP. Pathophysiology Associated with Traumatic Brain Injury: Current Treatments and Potential Novel Therapeutics. Cell Mol Neurobiol. 2017 May;37(4):571-585. doi: 10.1007/s10571-016-0400-1. Epub 2016 Jul 6.
PubMed 27383839
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medicolegal Aspects of Head Trauma in Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT05386966
- Acronym / sponsor ID
- Soh-Med-22-05-02
- Conditions
- Head Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 24 May 2022 (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.
Trauma is a critical global health problem. It represents the fifth leading cause of significant disability and is one of the most common causes of mortality in youth and adulthood, as one in 10 deaths worldwide occurred due to trauma.
The head is preferred target for criminal acts and is a favorite place for various pathological lesions .Traumatic head injury (THI)is one of the prevalent causes of global death and disability. lately, head injury (HI) cases have increased in both developed and developing nations. Therefore, it is of great value to evaluate the clinical and pathological features of head injury .
Every injury that results in harm to the scalp, skull or brain can be sort out as a HI which can be caused by traffic mishap, falls, sports and gunshot wounds. Vehicle accidents are one of the most prevalence causes of THI as they are deemed to be one of the main causes of fatality due to road-traffic accidents (RTA) .Among different type of the RTA, motorcycle accidents holds the number one cause of accident in most of the country .
Skull fracture and hemorrhage are common association, which may be present with head trauma and affect the outcome of the case.The skull fractures, especially by blunt force offer varying diagnostic and medico- legal problems to the medical jurists as well as to the clinicians.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnosed cases of head trauma at Department of Neurosurgery
Key inclusion criteria (1 listed)
- Diagnosed cases of head trauma
Key exclusion criteria (1 listed)
- Patients with deficient data i.e. escaped, discharged on demand before period of follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairePatient demographic data ( age, gender, residence , work ,Level of education) .Detailed history about the trauma (type, site , manner , mechanism of injury , actual cause of assault , post traumatic period till arrival to hospital ) .Clinical assessment ( Rapid neurological assessment , assesment of Scalp injury ,Presence of other body trauma ,Degree of severity of head injury according to GCS , Radiological finding. Treatment (Conservative or operative intervention ) .Follow up and outcome at the time of discharge by using the GOS .Expected time for healing (<20 day or >20 day ).Expectance for permanent infirmity | Other | – |
Primary outcome
The aim of the current study is to assess and describe the change in the medicolegal aspects of traumatic head injuries in sohag university hospital
Time frame: 1year
Expected time for healing and expectance for permanent infirmity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 29234838Chelly H, Bahloul M, Ammar R, Dhouib A, Mahfoudh KB, Boudawara MZ, Chakroun O, Chabchoub I, Chaari A, Bouaziz M. Clinical characteristics and prognosis of traumatic head injury following road traffic accidents admitted in ICU "analysis of 694 cases". Eur J Trauma Emerg Surg. 2019 Apr;45(2):245-253. doi: 10.1007/s00068-017-0885-4. Epub 2017 Dec 12.
- Background: PubMed 29773781Wang J, Han F, Zhao Q, Xia B, Dai J, Wang Q, Huang S, Le C, Li Z, Liu J, Yang M, Wan C, Wang J. Clinicopathological Characteristics of Traumatic Head Injury in Juvenile, Middle-Aged and Elderly Individuals. Med Sci Monit. 2018 May 18;24:3256-3264. doi: 10.12659/MSM.908728.
- Background: PubMed 27383839Pearn ML, Niesman IR, Egawa J, Sawada A, Almenar-Queralt A, Shah SB, Duckworth JL, Head BP. Pathophysiology Associated with Traumatic Brain Injury: Current Treatments and Potential Novel Therapeutics. Cell Mol Neurobiol. 2017 May;37(4):571-585. doi: 10.1007/s10571-016-0400-1. Epub 2016 Jul 6.
- Individual participant dataSharing planned: Undecided
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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.
Maha A Hilal, professor contact
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 Head Trauma, run by Sohag 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 1 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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naglaa G Ahmed, Demonstrator (01128614059, naglaagaber@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aim of the current study is to assess and describe the change in the medicolegal aspects of traumatic head injuries in sohag university hospital (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05386966, which also lists 3 linked publications.
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 26 Jan 2023.