CClinicalTrials.gg
RecruitingNCT06922396Updated Apr 10, 2025

Predictors of Mortality Among Patients With Head Trauma

An observational study in The Usefulness of Specific Scores in Predicting Mortality of Patients With Head Trauma in ICU, sponsored by Ayman Mahmoud Alsayes. Recruiting at 1 site in Egypt. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by Ayman Mahmoud Alsayes · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
140
Ages
16 Years to 75 Years
Sex
All
01

Study summary

Evaluate the usefulness of the APACHE II (Acute Physiology and Chronic Health Evaluation II), RTS (Revised trauma score), GCS (Glasgow Coma Scale) scores and various variables as age, sex, lab.data and complications in predicting mortality of patients with traumatic brain injury (TBI) in the intensive care unit (ICU).

Read the detailed description

Head injuries are a major cause of morbidity and mortality through out the world. It is estimated that 69 million people suffer from Traumatic Brain Injury (TBI) from all cases per year .

Current estimates suggest that about 4.48 million people lose their lives due to injuries which accounts for 8% of all deaths globally. Of these, an estimated 2 million deaths were attributed to the TBI, and the burden was concentrated in developing countries due to limited access to advanced life-sustaining measures after trauma .

In low-and middle-income countries, head injury patients have worse outcomes than patients in high-income countries . Several studies in Africa have found that death rates from head injury range from 4.2% to 35% .

Evidence suggests that the possible causes for the high mortality rate could be older age, male gender,low GCS, and cause of injuries are likely non-modifiable risk factors and hypoxia, hypotension, hyperthermia, hypo or hyperglycemia, and did not undergo surgery or poor adherence to management guidelines are possible modifiable risk factors .

Clinical presentation of patients and advanced rescue care by emergency teams are crucial factors to determining favorable outcomes. Accordingly, non-surgical management should emphases on rapid transportation, avoiding hypotension and hypoxia, hyperthermia, and medical management to reduce brain edema .

Accurate determination of the prognosis is crucial for the practitioners, in order to optimize and personalize treatment strategies. There is a degree of uncertainty in clinicians' expectations of patient outcomes, and prognostic models can help improve these expectations by providing probabilities of specific outcomes. Compared with the experience of physicians to judge the prognosis of patients, objective prognostic models would be able to give more accurate projections about specific variables such as number of hospitalizations and deaths .

The predictors of mortality modules used are GCS, APACHE II and RTS scores. GCS provides an objective recording of the state of consciousness of a person, which is the only variable referring to brain function in the APACHE II score. APACHE II score was primarily designed to predict mortality in ICUs. The famous models: the International Mission for Prognosis and Analysis of Clinical Trials (IMPACT) model and the Corticosteroid Randomization After Significant Head Injury (CRASH) model were weighted towards mixed TBI (moderate and severe TBI).

The management of TBI patients should be followed intracranial pressure monitoring is suggested to reduce post-traumatic death in the hospital within two weeks .

Unfortunately, pre hospital care is not well established and hospitals are not well equipped;this can increase the risk of secondary brain injury due to hypotension and hypoxia .

02

Conditions studied

  • The Usefulness of Specific Scores in Predicting Mortality of Patients With Head Trauma in ICU
03

In context

Craniocerebral Trauma

253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.

This study's planned enrollment of 140 is below the median of 180 across 108 observational studies indexed under Craniocerebral Trauma.

Browse Craniocerebral Trauma studies →

Lead sponsor

This is the only study on the registry with Ayman Mahmoud Alsayes as lead sponsor.

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

04

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

140 patients admitted to I.C.U during the period of the study, all the studied populations will diagnosed to have an acute traumatic brain injury (TBI).

Inclusion criteria

  • All patients with acute traumatic brain injury older than 16 years where presented in emergency department within 24 hours of trauma with a Glasgow coma scale less than 15

Exclusion criteria

Exclusion Criteria:

  • o Post cardiac arrest

    • Patients with GCS=3.
    • Patients with associated advanced cervical spine, maxillofacial, severe chest trauma.
    • Patients with previous neurological disorders
05

Study design

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

Groups and cohorts

  • Survivors group

    Other: Parameters on admission

  • Non survivors group

    Other: Parameters on admission

Interventions

  • OtherParameters on admission

    A: Parameters on admission: * Age. * Sex. * Comorbidities (DM, HTN, CKD, IHD, Liver Disease) * Mode of trauma. * Laboratory data (RBS, INR, AST, ALT, Urea, Creatinine, WBC ,HB, CK, Myoglobin). * Ct brain findings. * Scoring system (GCS, RTS, APACHE II). B: Parameters after 2 weeks: * Days on Mechanical Ventilation. * Medical or surgical management. * Complications (Pneumonia, DVT, septic shock, Pulmonary embolism, ARDS).

    Also known as: Parameters after 2 weeks

06

What researchers measure

Primary outcomes

  1. The studied patients will be observed for 1 month and mortality will be recorded.

    Time frame: average 6 to 9 months

07

Study locations

1 of 1 sites recruiting
  • Faculty Of Medicine , Ain Shams University
    Cairo, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06922396
Lead sponsor
Ayman Mahmoud Alsayes
Responsible party
Ayman Mahmoud Alsayes (Predictors of Mortality among Patients with Head Trauma, Ain Shams University) — Sponsor-investigator
First posted
Apr 10, 2025
Start date
Jun 1, 2024
Primary completion
May 1, 2025 (estimated)
Completion
Jun 20, 2025 (estimated)
Last update
Apr 10, 2025

Study contacts

Ayman Mahmoud Alsayes, Master
Contact
draymanalsayes@gmail.com
00201010283811

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

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