Traumatic Brain InjuryNCT06701279
Role of Electrocardiogram Abnormalities in Prediction of Mortality in Patients With Isolated Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients aged ≥ 18 years.
- In-patient diagnosed with any degree of isolated TBI.
Who cannot join
- Pediatric TBI patients aged below 18 years.
- Poly-traumatic patients.
- Cardiac arrest after trauma before arrival ED .
- Cardiac patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Traumatic Brain Injury
- Keywords
- Electrocardiogram
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Patients with brain traumatic injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate of TBI patients with ECG changes
Number of deaths' among TBI patients with ECG changes
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Mohamed Abdellatif, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701279
- Sponsor's protocol ID
- ECG Traumatic brain Injury
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 6885141GBD 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 35026139Gu 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Electrocardiogram Abnormalities in Prediction of Mortality in Patients With Isolated Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06701279
- Acronym / sponsor ID
- ECG Traumatic brain Injury
- Conditions
- Traumatic Brain Injury
- Keywords
- Electrocardiogram
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –Patients with brain traumatic injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult patients aged ≥ 18 years.
- In-patient diagnosed with any degree of isolated TBI.
Key exclusion criteria (4 listed)
- Pediatric TBI patients aged below 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality rate of TBI patients with ECG changes
Time frame: 48 hours
Number of deaths' among TBI patients with ECG changes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Results publication: PubMed 6885141Beverland 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.
- Results publication: PubMed 35026139GBD 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.
- Results publication: PubMed 34818648Gu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yomna Mohamed Abdellatif, resident doctor (+20 10 10008691, ala223897@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate of TBI patients with ECG changes (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06701279, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.