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NCT Number: NCT06701279

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality rate of TBI patients with ECG changes

    Time frame: 48 hours

    Number of deaths' among TBI patients with ECG changes

Study contacts

Contact information is provided by the study sponsor or research team.

Yomna Mohamed Abdellatif, resident doctor

CONTACT

[email protected]

+20 10 10008691

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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