Postoperative Intracranial HematomaNCT06036732
A New Approach in Intensive Care Unit Consciousness Assessment: FIVE Score
An observational study of Postoperative Intracranial Hematoma and Postoperative Intracranial Haemorrhage, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
1. The primary aim of this study is to investigate the correlation between the length of ICU stay and a newly developed FIVE score in neuro-intensive care patients. 2. The secondary objectives are to evaluate the impact of the FIVE score on hospital length of stay, Modified Rankin Scale, and mortality, as well as to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Intracranial Hematoma, Postoperative Intracranial Haemorrhage, Supratentorial Cancer
- How many people
- 223 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 25 Feb 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients between the ages of 18 and 80, who were monitored in the Neurosurgical Intensive Care Unit and had a history of ischemic or hemorrhagic stroke within the last 6 months, underwent infratentorial craniotomy, supratentorial craniotomy, endoscopic surgery, vascular surgery, epilepsy surgery, hydrocephalus surgery, or neurovascular intervention, were included in the study
Who may be able to join
- between the ages of 18 and 80
- who were monitored in the Neurosurgical Intensive Care Unit
- had a history of ischemic or hemorrhagic stroke within the last 6 months
- underwent infratentorial craniotomy
- supratentorial craniotomy
- endoscopic surgery
Show all 10Show fewer
- vascular surgery
- epilepsy surgery
- hydrocephalus surgery
- neurovascular intervention
Who cannot join
- patients over 80 years of age
- under 18 years of age
- patients who were sedated
- patients who were administered neuromuscular blockers during intensive care follow-up
- patients with diagnosed psychiatric illness
- patients who were alcohol or drug addicts
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University- Cerrahpasa(IUC)
Istanbul, Fatih, 34098
Merve Tugba Ozfidan Donmez, MD, 00905056444156, mtozfidann@gmail.com
About this study
Official title: The New Developed FIVE Score and Its Comparison With GCS and FOUR Scores Regarding Length of Hospital Stay Morbidity and Mortality in Neuro-intensive Care Patients. an Observational Prospective Study
- The primary aim of this study is to investigate the correlation between the length of ICU stay and a newly developed FIVE score in neuro-intensive care patients.
- The secondary objectives are to evaluate the impact of the FIVE score on hospital length of stay, Modified Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR, and FIVE scores
Read the detailed description
Consciousness monitoring is crucial in neuro-intensive care. Despite the use of different scoring systems to establish a common language among evaluators, the Glasgow Coma Scale (GCS) remains the most widely used in clinical practice. In GCS evaluation, verbal response, motor response, and eye response are assessed. Another scoring system, FOUR (Full Outline of UnResponsiveness ) Score is similar to the Glasgow Coma Score (GCS). But it is designed to provide a more comprehensive neurological assessment. The FOUR score evaluates four areas: including eye opening, motor response, brainstem reflexes, and respiration, and assigns a score for each area. A comprehensive education regarding those scores was given the intensive care healthcare providers before the trial.
In this study, the investigators developed the Full Intracranial Validity Evaluation (FIVE) Score, by adding the mean arterial pressure and gag reflex components to the FOUR score. The investigators believe that this new score, which can be used for clinical monitoring, may offer an alternative to FOUR and GCS monitoring. According to this scoring system, in addition to the criteria for the FOUR score, patients with a mean arterial pressure between 60-130mmHg receive 2 points; patients under inotropic support with a mean arterial pressure between 60-130mmHg receive 1 point; patients with a mean arterial pressure below 60mmHg or above 130mmHg receive 0 points. Additionally, for patients with infratentorial mass, the investigators add the assessment of gag reflex in the calculation of the FIVE score. If the reflex is absent, 0 points are given; if it is unilateral, 1 point is given, and if it is preserved, 2 points are given.
The demographic data, diagnoses, systemic comorbidities, the American Society of Anaesthesiologists (ASA) score, the Charlson Comorbidity Index (CCI), and the APACHE II scores of patients were recorded.
The GCS, FOUR, and FIVE scores of the patients were recorded at neuro ICU admission, every 12 hours during neuro ICU follow-up period and discharge. In our clinic, GCS monitoring is routinely performed hourly for every patient admitted to the ICU. For patients with a decrease of two or more points in GCS score, FOUR and FIVE scores were re-evaluated and recorded without waiting for the 12 hours. Besides this, the worst, the best and the mean GCS, FOUR, and FIVE scores were recorded in the neuro ICU follow-up period. The assessment count of the GCS, FOUR, and FIVE scores during clinical follow-up was recorded.
The length of ICU and hospital stay were recorded. The Modified Rankin Scale of the patients was recorded six months after ICU discharge.
The primary aim of this study is to investigate the correlation between the length of ICU stay and a newly developed FIVE score in neuro-intensive care patients. The secondary objectives are to evaluate the impact of the FIVE score on length of hospital stay, Modified Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR, and FIVE scores.
- Conditions
- Postoperative Intracranial Hematoma, Postoperative Intracranial Haemorrhage, Supratentorial Cancer, Infratentorial Neoplasms, Arnold Chiari Malformation, Subarachnoid Hemorrhage
- Keywords
- FIVE Score, FOUR Score, GCS, Modified Rankin Score, Neuro-ICU
- Medical subject headings
- Supratentorial Neoplasms, Infratentorial Neoplasms, Arnold-Chiari Malformation, Subarachnoid Hemorrhage, Brain Injuries, Traumatic, Epilepsy, Temporal Lobe, Coma, Unconsciousness
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FIVE Scores
Full Intracranial Validity Evaluation, minimum value:0, maximum value: 20, higher scores mean a better situation
Measured: baseline, 12 hours intervals, up to an hour of ICU discharge
Change in GKS Scores
Glasgow Coma Score, minimum value:3, maximum value: 15, higher scores mean a better situation
Measured: baseline, 12 hours intervals, up to an hour of ICU discharge
Modified Rankin Scale
In scoring post-discharge morbidity six months after intensive care unit discharge, Modified Rankin Score is used. minimum value:0, maximum value:6, higher scores mean a worse outcome
Measured: six months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion25 Jan 2024 (estimated)
- Study completion25 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Intracranial HematomaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 223 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve tugba ozfidan donmez, Istanbul University - Cerrahpasa
- Investigators
- Ozlem Korkmaz Dilmen, MD, Study chair, Istanbul University - CerrahpasaYusuf Tunali, MD, Study director, Istanbul University - CerrahpasaFatma Eren Akcil, MD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036732
- Sponsor's protocol ID
- E-72109855-604.01.01-7591
- Status last verified
- Sep 2023
- First submitted
- 27 Apr 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Glasgow Coma Scale (GCS) and Four/Five Scores, along with the highest, lowest, and average scores, discharge scores, Modified Rankin Scores at 6 months post-discharge, and length of stay information measured upon admission to the intensive care unit will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New Developed FIVE Score and Its Comparison With GCS and FOUR Scores Regarding Length of Hospital Stay Morbidity and Mortality in Neuro-intensive Care Patients. an Observational Prospective Study
- ClinicalTrials.gov ID
- NCT06036732
- Acronym / sponsor ID
- E-72109855-604.01.01-7591
- Conditions
- Postoperative Intracranial Hematoma, Postoperative Intracranial Haemorrhage, Supratentorial Cancer, Infratentorial Neoplasms, Arnold Chiari Malformation, Subarachnoid Hemorrhage
- Keywords
- FIVE Score, FOUR Score, GCS, Modified Rankin Score, Neuro-ICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 223 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 25 Jan 2024 (estimated)
- Study completion
- 25 Feb 2024 (estimated)
- First posted
- 14 Sep 2023 (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.
- The primary aim of this study is to investigate the correlation between the length of ICU stay and a newly developed FIVE score in neuro-intensive care patients.
- The secondary objectives are to evaluate the impact of the FIVE score on hospital length of stay, Modified Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR, and FIVE scores
Detailed description
Consciousness monitoring is crucial in neuro-intensive care. Despite the use of different scoring systems to establish a common language among evaluators, the Glasgow Coma Scale (GCS) remains the most widely used in clinical practice. In GCS evaluation, verbal response, motor response, and eye response are assessed. Another scoring system, FOUR (Full Outline of UnResponsiveness ) Score is similar to the Glasgow Coma Score (GCS). But it is designed to provide a more comprehensive neurological assessment. The FOUR score evaluates four areas: including eye opening, motor response, brainstem reflexes, and respiration, and assigns a score for each area. A comprehensive education regarding those scores was given the intensive care healthcare providers before the trial.
In this study, the investigators developed the Full Intracranial Validity Evaluation (FIVE) Score, by adding the mean arterial pressure and gag reflex components to the FOUR score. The investigators believe that this new score, which can be used for clinical monitoring, may offer an alternative to FOUR and GCS monitoring. According to this scoring system, in addition to the criteria for the FOUR score, patients with a mean arterial pressure between 60-130mmHg receive 2 points; patients under inotropic support with a mean arterial pressure between 60-130mmHg receive 1 point; patients with a mean arterial pressure below 60mmHg or above 130mmHg receive 0 points. Additionally, for patients with infratentorial mass, the investigators add the assessment of gag reflex in the calculation of the FIVE score. If the reflex is absent, 0 points are given; if it is unilateral, 1 point is given, and if it is preserved, 2 points are given.
The demographic data, diagnoses, systemic comorbidities, the American Society of Anaesthesiologists (ASA) score, the Charlson Comorbidity Index (CCI), and the APACHE II scores of patients were recorded.
The GCS, FOUR, and FIVE scores of the patients were recorded at neuro ICU admission, every 12 hours during neuro ICU follow-up period and discharge. In our clinic, GCS monitoring is routinely performed hourly for every patient admitted to the ICU. For patients with a decrease of two or more points in GCS score, FOUR and FIVE scores were re-evaluated and recorded without waiting for the 12 hours. Besides this, the worst, the best and the mean GCS, FOUR, and FIVE scores were recorded in the neuro ICU follow-up period. The assessment count of the GCS, FOUR, and FIVE scores during clinical follow-up was recorded.
The length of ICU and hospital stay were recorded. The Modified Rankin Scale of the patients was recorded six months after ICU discharge.
The primary aim of this study is to investigate the correlation between the length of ICU stay and a newly developed FIVE score in neuro-intensive care patients. The secondary objectives are to evaluate the impact of the FIVE score on length of hospital stay, Modified Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR, and FIVE scores.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients between the ages of 18 and 80, who were monitored in the Neurosurgical Intensive Care Unit and had a history of ischemic or hemorrhagic stroke within the last 6 months, underwent infratentorial craniotomy, supratentorial craniotomy, endoscopic surgery, vascular surgery, epilepsy surgery, hydrocephalus surgery, or neurovascular intervention, were included in the study
Key inclusion criteria (10 listed)
- between the ages of 18 and 80
- who were monitored in the Neurosurgical Intensive Care Unit
- had a history of ischemic or hemorrhagic stroke within the last 6 months
- underwent infratentorial craniotomy
- supratentorial craniotomy
Key exclusion criteria (6 listed)
- patients over 80 years of age
- under 18 years of age
- patients who were sedated
- patients who were administered neuromuscular blockers during intensive care follow-up
- patients with diagnosed psychiatric illness
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
Change in FIVE Scores
Time frame: baseline, 12 hours intervals, up to an hour of ICU discharge
Full Intracranial Validity Evaluation, minimum value:0, maximum value: 20, higher scores mean a better situation
Change in GKS Scores
Time frame: baseline, 12 hours intervals, up to an hour of ICU discharge
Glasgow Coma Score, minimum value:3, maximum value: 15, higher scores mean a better situation
Modified Rankin Scale
Time frame: six months after ICU discharge
In scoring post-discharge morbidity six months after intensive care unit discharge, Modified Rankin Score is used. minimum value:0, maximum value:6, higher scores mean a worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: Undecided. Glasgow Coma Scale (GCS) and Four/Five Scores, along with the highest, lowest, and average scores, discharge scores, Modified Rankin Scores at 6 months post-discharge, and length of stay information measured upon admission to the intensive care unit will be shared.
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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. This study is not recruiting at the moment.
Ozlem Korkmaz Dilmen, MD study chair
Istanbul University - Cerrahpasa
Yusuf Tunali, MD study director
Istanbul University - Cerrahpasa
Fatma Eren Akcil, MD study director
Istanbul University - Cerrahpasa
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 Postoperative Intracranial Hematoma and Postoperative Intracranial Haemorrhage, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 10 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Sep 2023. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve Tugba Ozfidan Donmez, MD (00905056444156, mtozfidann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FIVE Scores (time frame: baseline, 12 hours intervals, up to an hour of ICU discharge). The study lists 3 primary outcomes in all. 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 14 Sep 2023.