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

November 20, 2024 updated by: Yomna Mohamed Abdellatif, Assiut University

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).

Study Overview

Status

Not yet recruiting

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yomna Mohamed Abdellatif, resident doctor
  • Phone Number: +20 10 10008691
  • Email: ala223897@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with brain traumatic injury who will match the eligible criteria will be included. In this study, patients with trauma who will attend to emergency department will be subjected to primary and secondary survey. On attendance, after primary survey completion; ECG will be conducted to all patients. Any patients will have cardiac tamponade, aortic injury or for cardio-thoracic emergent operation will be excluded. Also, pediatric patients aged below 18 years old or adults get arrested before ED arrival will be excluded.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
group 1
Patients with brain traumatic injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate of TBI patients with ECG changes
Time Frame: 48 hours
Number of deaths' among TBI patients with ECG changes
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Estimated)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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