CClinicalTrials.gg
Not yet recruitingNCT06701279Updated Nov 22, 2024

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

An observational study in Traumatic Brain Injury, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
54
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the 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.

02

Conditions studied

  • Traumatic Brain Injury

Keywords

  • Electrocardiogram
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 54 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pediatric TBI patients aged below 18 years.

    • Poly-traumatic patients.
    • Cardiac arrest after trauma before arrival ED .
    • Cardiac patients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
54 participants (estimated)
Patient registry
No

Groups and cohorts

  • group 1

    Patients with brain traumatic injury

06

What researchers measure

Primary outcomes

  1. Mortality rate of TBI patients with ECG changes

    Number of deaths' among TBI patients with ECG changes

    Time frame: 48 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 6885141 ↗
  • 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. PubMed 35026139 ↗
  • 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. PubMed 34818648 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06701279
Lead sponsor
Assiut University
Responsible party
Yomna Mohamed Abdellatif (resident doctor at Emergency medicine unit Faculty of Medicine, Assiut University, Assiut University) — Principal investigator
First posted
Nov 22, 2024
Start date
Dec 1, 2024 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Nov 22, 2024

Study contacts

Yomna Mohamed Abdellatif, resident doctor
Contact
ala223897@gmail.com
+20 10 10008691

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion