NCT06701279

Brief 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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Dec 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Dec 2024Jan 2027

First Submitted

Initial submission to the registry

November 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

November 20, 2024

Last Update Submit

November 20, 2024

Conditions

Keywords

Electrocardiogram

Outcome Measures

Primary Outcomes (1)

  • Mortality rate of TBI patients with ECG changes

    Number of deaths' among TBI patients with ECG changes

    48 hours

Study Arms (1)

group 1

Patients with brain traumatic injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Pediatric TBI patients aged below 18 years.
  • Poly-traumatic patients.
  • Cardiac arrest after trauma before arrival ED .
  • Cardiac patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 6885141BACKGROUND
  • 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.

    PMID: 35026139BACKGROUND
  • 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.

    PMID: 34818648BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Yomna Mohamed Abdellatif, resident doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at Emergency medicine unit Faculty of Medicine, Assiut University

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 22, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

November 22, 2024

Record last verified: 2024-11