NCT05386966

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

May 18, 2022

Last Update Submit

January 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    1year

Interventions

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

Eligibility Criteria

Age1 Day+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnosed cases of head trauma at Department of Neurosurgery

You may qualify if:

  • Diagnosed cases of head trauma

You may not qualify if:

  • Patients with deficient data i.e. escaped, discharged on demand before period of follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • 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.

    PMID: 29234838BACKGROUND
  • Wang 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.

    PMID: 29773781BACKGROUND
  • Pearn 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.

    PMID: 27383839BACKGROUND

MeSH Terms

Conditions

Craniocerebral Trauma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Naglaa G Ahmed, Demonstrator

CONTACT

Maha A Hilal, professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator of Forensic Medicine & Clinical Toxicology Faculty of Medicine SohagUniversity

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 24, 2022

Study Start

July 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations