Role of Electrocardiogram Abnormalities in Prediction of Mortality in Patients with Isolated Traumatic Brain Injury

NCT ID: NCT06701279

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2027-01-01

Brief Summary

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Most common causes of ECG changes, from surgical view, are extradural haemorrhage , intracerebral haemorrhage, intraventricular haemorrhage and subarachnoid haemorrhage. A previous study reprorted ST-T wave changes in 41.5% of acute brain injury patients. In another paper , the prolonged QT interval was existed in (42.4%) of the included patients, ST depression (3.4%), ST elevation (3.4%),and morphologic end-repolarization abnormalities (10.2%). One paper reported that inverted T Wave was prevalent in 2% of the study population on admission and 0 after 24 hours of admission. The prognostic value of ECG abnormalities on the TBI patient fate is still under research.

In this study we aim to observe any correlation between ECG changes in patients with isolated TBI who will attend to ED in Assiut university hospital.

Aim of study:

Predictive value in mortality of ECG abnormalities in patients with isolated Traumatic brain injury (TBI).

Detailed Description

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Traumatic brain Injury (TBI) is a brain affection occurring due to whether external blunt or penetrating trauma applied to the head. It may results from gun-shot, car accident, falling, assault or even suicide. Recently, TBI is considered one of the major leading causes to disability and death . Also variant neurological diseases e.g. neurodegenerative and demential diseases are reported as long term complication of TBI . According to Global Burden of Diseases (GBD) TBI is defined as an external force applied to the head that causes varying degrees of damage to the brain and classified into mild, moderate and sever types according to Glasgow Coma Score (GCS). Globally in 2014, epidemiological estimations reported 2.53 million TBI-related emergency department (ED) visits from CDC documentation and in 2019, incidence of TBI was 27.16 million accounting for 346 per 100,000 populations and affecting the global economy what made it a major public health problem.

As TBI is a comorbid, disabling and a significant factor in world-wide morality; a lot of research papers are conducted concerning pathophysiology, epidemiology, risk factors, management, and treatment especially in neurosurgical field. From etiological view, falling is the most common factor for TBI followed by motor and motor-cyclic accidents. Concerning of age, the most vularnable group is elderly people who aged above 65 years followed by pediatrics aged below 4 years .

Epidemiologic estimates about TBI and its mortality rate faces difficulty because of some mild cases don't go to ED and some of sever cases died after accident.

in the last decade, research papers reported electrocardiogram (ECG) changes and abnormalities in patients with brain injury whether it is pathological as stroke or traumatic by external force. The cause of ECG changes in TBI patients is still searched but one of the explanations suggesting that it occurs due to autonomic instability and cardiac dysfunction as myocardial ischemic - like changes.

Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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group 1

Patients with brain traumatic injury

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients aged ≥ 18 years.
* In-patient diagnosed with any degree of isolated TBI.

Exclusion Criteria

* Pediatric TBI patients aged below 18 years.

* Poly-traumatic patients.
* Cardiac arrest after trauma before arrival ED .
* Cardiac patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Yomna Mohamed Abdellatif

resident doctor at Emergency medicine unit Faculty of Medicine, Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yomna Mohamed Abdellatif, resident doctor

Role: CONTACT

+20 10 10008691

References

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Beverland DE, Rutherford WH. An assessment of the validity of the injury severity score when applied to gunshot wounds. Injury. 1983 Jul;15(1):19-22. doi: 10.1016/0020-1383(83)90156-0.

Reference Type BACKGROUND
PMID: 6885141 (View on PubMed)

GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.

Reference Type BACKGROUND
PMID: 35026139 (View on PubMed)

Gu D, Ou S, Liu G. Traumatic Brain Injury and Risk of Dementia and Alzheimer's Disease: A Systematic Review and Meta-Analysis. Neuroepidemiology. 2022;56(1):4-16. doi: 10.1159/000520966. Epub 2021 Nov 24.

Reference Type BACKGROUND
PMID: 34818648 (View on PubMed)

Other Identifiers

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ECG Traumatic brain Injury

Identifier Type: -

Identifier Source: org_study_id

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