The Usefulness of Specific Scores in Predicting Mortality of Patients With Head Trauma in ICUNCT06922396
Predictors of Mortality Among Patients With Head Trauma
An observational study of The Usefulness of Specific Scores in Predicting Mortality of Patients With Head Trauma in ICU, run by Ayman Mahmoud Alsayes at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- The Usefulness of Specific Scores in Predicting Mortality of Patients With Head Trauma in ICU
- What is being tested?
- Parameters on admission
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 20 Jun 2025
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- o Post cardiac arrest
- Patients with GCS=3.
- Patients with associated advanced cervical spine, maxillofacial, severe chest trauma.
- Patients with previous neurological disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty Of Medicine , Ain Shams University
Cairo
faculty of medicine, 20226857539, REC-FMASU@med.asu.edu.eg
About this study
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 .
- Conditions
- The Usefulness of Specific Scores in Predicting Mortality of Patients With Head Trauma in ICU
- Being tested
- Parameters on admission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parameters on admissionOther
Also called Parameters after 2 weeks
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).
| Study group | Role | What they receive |
|---|---|---|
| Survivors group | Not described Receives: Other: Parameters on admission | |
| Non survivors group | Not described Receives: Other: Parameters on admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
The studied patients will be observed for 1 month and mortality will be recorded.
Measured: average 6 to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Jun 2024
- Primary completion1 May 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Usefulness of Specific Scores in Predicting Mortality of Patients With Head Trauma in ICUStudies of the same condition, open and under way.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayman Mahmoud Alsayes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayman Mahmoud Alsayes, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922396
- Sponsor's protocol ID
- Mortality prediction in TBI
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Mortality Among Patients With Head Trauma
- ClinicalTrials.gov ID
- NCT06922396
- Acronym / sponsor ID
- Mortality prediction in TBI
- Conditions
- The Usefulness of Specific Scores in Predicting Mortality of Patients With Head Trauma in ICU
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ayman Mahmoud AlsayesUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 10 Apr 2025 (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.
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).
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors group | – | Other: Parameters on admission |
| Non survivors group | – | Other: Parameters on admission |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- o Post cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parameters on admissionAlso: Parameters after 2 weeksA: 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). | Other | Non survivors group, Survivors group |
Primary outcome
The studied patients will be observed for 1 month and mortality will be recorded.
Time frame: average 6 to 9 months
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 10 Apr 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Usefulness of Specific Scores in Predicting Mortality of Patients With Head Trauma in ICU, run by Ayman Mahmoud Alsayes at 1 site in Egypt.
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 1 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: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ayman Mahmoud Alsayes, Master (00201010283811, draymanalsayes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The studied patients will be observed for 1 month and mortality will be recorded. (time frame: average 6 to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2025.