Subarachnoid Hemorrhage, AneurysmalSAHstdyNCT06563219
Predicting 28-Day Mortality in Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage, Aneurysmal, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators investigated the predictive ability of clinical and radiological scores, including the Glasgow coma scale (GCS), Hunt-Hess, World Federation of Neurological Surgeons (WFNS), and modified Fisher scales, as well as combined clinical scores such as the VASOGRADE and Ogilvy-Carter rating scales, for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Glasgow coma scale, Hunt-Hess scale and World Federation of Neurological Surgeons (WFNS) scale
- How many people
- 451 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 1 Aug 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: This multicenter, retrospective, observational cohort study enrolled 451 consecutive adult patients (aged ≥ 18 years) who presented to the emergency departments of the six major and highest-volume tertiary hospitals in Istanbul with non-traumatic Subarachnoid Hemorrhage between September 2020 and September 2023. Data were collected by searching for I60.9 International Classification of Disease (ICD) codes in the hospital's automation systems and archives.
Who may be able to join
- patients (aged ≥ 18 years) who presented to the emergency department with non-traumatic Subarachnoid Hemorrhage between September 2020 and September 2023
Who cannot join
- patients younger than 18 years
- patients with missing information
- patients with traumatic SAH
- patients with subdural or epidural hemorrhage
- patients with concurrent ischemic stroke
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Fatih, 34265
About this study
Official title: Comparative Analysis of Traditional Clinical Scores and Combined Grading Systems in Predicting 28-Day Mortality in Non-Traumatic Subarachnoid Hemorrhage
The investigators investigated the predictive ability of clinical and radiological scores, including the Glasgow coma scale (GCS), Hunt-Hess, World Federation of Neurological Surgeons (WFNS), and modified Fisher scales, as well as combined clinical scores such as the VASOGRADE and Ogilvy-Carter rating scales, for 28-day mortality in patients presenting to the emergency department (ED) with non-traumatic subarachnoid hemorrhage (SAH). Specifically, we tested the hypothesis that combined clinical scores are more reliable and superior to non-combined clinical and radiological scores in predicting 28-day mortality in non-traumatic SAH.
Read the detailed description
Patients were divided into survivors and non-survivors, with surviving patients further categorized as either mobile or immobile based on the Glasgow outcome scale. Accordingly, patients who were dependent on daily support or in a coma were classified as immobile, whereas patients who had returned to normal life or were independent in their daily activities were classified as mobile. The demographic (age and sex), comorbidities (hypertension, diabetes mellitus [DM] and/or coronary artery disease [CAD]), vital signs (systolic blood pressure, heart rate, respiratory rate, and peripheral capillary oxygen saturation [sPO2]), and clinical assessment tools (GCS, Hunt Hess, WFNS, modified Fisher, VASOGRADE, and Ogilvy-Carter rating scales) on admission were compared between the groups to identify factors associated with 28-day mortality and neurological survival. Independent predictors of mortality were determined by multivariate logistic regression analysis of variables (demographic characteristics, clinical characteristics, and trauma scores) that differed significantly between survivors and non-survivors. An area under the curve (AUC) analysis was then conducted to identify which trauma score is the most reliable and superior predictor of mortality.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- Glasgow coma scale, Hunt-Hess scale, World Federation of Neurological Surgeons (WFNS) scale, modified Fisher scale, VASOGRADE scale
- Keywords
- Subarachnoid Hemorrhage, Aneurysmal, Non-traumatic, Glasgow coma scale, World federation of neurological surgeons scale, modified Fisher scale, VASOGRADE scale, Ogilvy-Carter scale, 28-day mortality
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glasgow coma scaleOther
The levels of response in the components of the Glasgow Coma Scale are 'scored' from 1, for no response, up to normal values of 4 (Eye-opening response) 5 ( Verbal response) and 6 (Motor response) The total Coma Score thus has values between three and 15, three being the worst and 15 being the highest.
Hunt-Hess scaleOther
The Hunt-Hess scale was used to assess SAH severity according to the clinical presentation and the visible neurological deficits. The Grades run from 1 to 5:
- Grade 1: Asymptomatic or minimal headache, slight neck stiffness.
- Grade 2: Moderate to severe headache, and neck stiffness, but no neurological deficit except cranial nerve palsy.
- Grade 3: Drowsiness, confusion, or a mild focal deficit.
- Grade 4: Stupor, moderate to severe hemiparesis, early decerebrate rigidity, and vegetative disturbance.
- Grade 5: Deep coma, decerebrate rigidity, and a moribund appearance.
World Federation of Neurological Surgeons (WFNS) scaleOther
The World Federation of Neurological Surgeons (WFNS) scale, introduced in 1988, is used to evaluate the clinical severity of patients with SAH. This scale is derived from the GCS score and considers the presence of motor deficits:
- Grade 1: GCS score of 15, no motor deficit
- Grade 2: GCS score of 13 to 14, no motor deficit
- Grade 3: GCS score of 13 to 14, with motor deficit
- Grade 4: GCS score of 7 to 12, with or without motor deficit
- Grade 5: GCS score of 3 to 6, with or without motor deficit
modified Fisher scaleOther
The modified Fisher scale was used to evaluate SAH severity by reference to the extent of hemorrhage as revealed by CT of the brain. Four grades are depending on the degree of bleeding observed:
- Grade 0: No hemorrhage apparent in CT.
- Grade 1: Minimal hemorrhage without intraventricular hemorrhage (IVH).
- Grade 2: Thin or diffusely thin (<1mm) hemorrhage with bilateral IVH.
- Grade 3: Thick (> 1 mm) hemorrhage without bilateral IVH.
- Grade 4: Thick (> 1 mm) hemorrhage with bilateral IVH.
VASOGRADE scaleOther
The VASOGRADE scale was established to estimate the risk of delayed cerebral ischemia following SAH. This scale is based on the WFNS and the modified Fisher scales at admission. There are three categories:
- Green: WFNS score of 1 or 2 and modified Fisher scale of 1 or 2.
- Yellow: WFNS score of 1 or 3 and modified Fisher scale of 3 or 4.
- Red: WFNS score of 4 or 5 and any modified Fisher scale score.
Ogilvy and Carter scaleOther
The Ogilvy and Carter scale is a grading system used to predict the outcomes of surgical treatment in patients with SAH due to a ruptured aneurysm. The scale considers multiple factors, including age, Hunt and Hess grade, Fisher grade, and aneurysm size, with a score assigned to each of these variables:
- Age greater than 50
- Hunt and Hess grade of 4 to 5
- Fisher grade scores of 3 to 4
- Aneurysm size >10 mm
- An additional point is added for a giant posterior circulation aneurysm (≥25 mm)
| Study group | Role | What they receive |
|---|---|---|
| Survivors | Survivors were defined as patients who were still alive after 28 days of admission to the emergency department. Receives: Other: Glasgow coma scale; Other: Hunt-Hess scale; Other: World Federation of Neurological Surgeons (WFNS) scale; Other: modified Fisher scale; Other: VASOGRADE scale; Other: Ogilvy and Carter scale | |
| Non-survivors | Non-survivors had passed away within 28 days of admission to the emergency department. Receives: Other: Glasgow coma scale; Other: Hunt-Hess scale; Other: World Federation of Neurological Surgeons (WFNS) scale; Other: modified Fisher scale; Other: VASOGRADE scale; Other: Ogilvy and Carter scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive ability of Glasgow coma scale for 28-day mortality
The investigators assessed the predictive ability of Glasgow coma scale in determining 28-day mortality.
Measured: From admission to 28 days
Predictive ability of Hunt-Hess scale for 28-day mortality
The investigators assessed the predictive ability of Hunt-Hess scale in determining 28-day mortality.
Measured: From admission to 28 days
Predictive ability of World Federation of Neurological Surgeons (WFNS) scale for 28-day mortality
The investigators assessed the predictive ability of World Federation of Neurological Surgeons (WFNS) scale in determining 28-day mortality.
Measured: From admission to 28 days
Predictive ability of modified Fisher scale for 28-day mortality
The investigators assessed the predictive ability of modified Fisher scale in determining 28-day mortality.
Measured: From admission to 28 days
Predictive ability of VASOGRADE scale for 28-day mortality
The investigators assessed the predictive ability of VASOGRADE scale in determining 28-day mortality.
Measured: From admission to 28 days
Predictive ability of Ogilvy-Carter rating scale for 28-day mortality
The investigators assessed the predictive ability of Ogilvy-Carter rating scale in determining 28-day mortality.
Measured: From admission to 28 days
Secondary outcomes (6)
Predictive ability of Glasgow coma scale for neurological survival
The investigators assessed the predictive ability of Glasgow coma scale in determining neurological survival
Measured: From admission to 28 days
Predictive ability of Hunt-Hess scale for neurological survival
The investigators assessed the predictive ability of Hunt-Hess scale in determining neurological survival
Measured: From admission to 28 days
Predictive ability of World Federation of Neurological Surgeons (WFNS) scale for neurological survival
The investigators assessed the predictive ability of World Federation of Neurological Surgeons (WFNS) scale in determining neurological survival
Measured: From admission to 28 days
Predictive ability of modified Fisher scale for neurological survival
The investigators assessed the predictive ability of modified Fisher scale in determining neurological survival
Measured: From admission to 28 days
Predictive ability of VASOGRADE scale for neurological survival
The investigators assessed the predictive ability of VASOGRADE scale in determining neurological survival
Measured: From admission to 28 days
Predictive ability of Ogilvy-Carter rating scale for neurological survival
The investigators assessed the predictive ability of Ogilvy-Carter rating scale in determining neurological survival
Measured: From admission to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Sep 2020
- Primary completion1 Sep 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies 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
- Retrospective
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adem Az, Haseki Training and Research Hospital
- Investigators
- Adem Az, M.D., Principal investigator, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563219
- Sponsor's protocol ID
- 38-2024
- Acronym
- SAHstdy
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Stored in non-publicly available Available on request
Publications
Sharma D. Perioperative Management of Aneurysmal Subarachnoid Hemorrhage. Anesthesiology. 2020 Dec 1;133(6):1283-1305. doi: 10.1097/ALN.0000000000003558.
PubMed 32986813Hijdra A, van Gijn J, Nagelkerke NJ, Vermeulen M, van Crevel H. Prediction of delayed cerebral ischemia, rebleeding, and outcome after aneurysmal subarachnoid hemorrhage. Stroke. 1988 Oct;19(10):1250-6. doi: 10.1161/01.str.19.10.1250.
PubMed 3176085Rosen DS, Macdonald RL. Subarachnoid hemorrhage grading scales: a systematic review. Neurocrit Care. 2005;2(2):110-8. doi: 10.1385/NCC:2:2:110.
PubMed 16159052Ogilvy CS, Carter BS. A proposed comprehensive grading system to predict outcome for surgical management of intracranial aneurysms. Neurosurgery. 1998 May;42(5):959-68; discussion 968-70. doi: 10.1097/00006123-199805000-00001.
PubMed 9588539Takagi K, Tamura A, Nakagomi T, Nakayama H, Gotoh O, Kawai K, Taneda M, Yasui N, Hadeishi H, Sano K. How should a subarachnoid hemorrhage grading scale be determined? A combinatorial approach based solely on the Glasgow Coma Scale. J Neurosurg. 1999 Apr;90(4):680-7. doi: 10.3171/jns.1999.90.4.0680.
PubMed 10193613Dengler NF, Sommerfeld J, Diesing D, Vajkoczy P, Wolf S. Prediction of cerebral infarction and patient outcome in aneurysmal subarachnoid hemorrhage: comparison of new and established radiographic, clinical and combined scores. Eur J Neurol. 2018 Jan;25(1):111-119. doi: 10.1111/ene.13471. Epub 2017 Nov 2.
PubMed 28940973
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Traditional Clinical Scores and Combined Grading Systems in Predicting 28-Day Mortality in Non-Traumatic Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT06563219
- Acronym / sponsor ID
- SAHstdy / 38-2024
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- Subarachnoid Hemorrhage, Aneurysmal, Non-traumatic, Glasgow coma scale, World federation of neurological surgeons scale, modified Fisher scale, VASOGRADE scale, Ogilvy-Carter scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 20 Aug 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.
The investigators investigated the predictive ability of clinical and radiological scores, including the Glasgow coma scale (GCS), Hunt-Hess, World Federation of Neurological Surgeons (WFNS), and modified Fisher scales, as well as combined clinical scores such as the VASOGRADE and Ogilvy-Carter rating scales, for 28-day mortality in patients presenting to the emergency department (ED) with non-traumatic subarachnoid hemorrhage (SAH). Specifically, we tested the hypothesis that combined clinical scores are more reliable and superior to non-combined clinical and radiological scores in predicting 28-day mortality in non-traumatic SAH.
Detailed description
Patients were divided into survivors and non-survivors, with surviving patients further categorized as either mobile or immobile based on the Glasgow outcome scale. Accordingly, patients who were dependent on daily support or in a coma were classified as immobile, whereas patients who had returned to normal life or were independent in their daily activities were classified as mobile. The demographic (age and sex), comorbidities (hypertension, diabetes mellitus [DM] and/or coronary artery disease [CAD]), vital signs (systolic blood pressure, heart rate, respiratory rate, and peripheral capillary oxygen saturation [sPO2]), and clinical assessment tools (GCS, Hunt Hess, WFNS, modified Fisher, VASOGRADE, and Ogilvy-Carter rating scales) on admission were compared between the groups to identify factors associated with 28-day mortality and neurological survival. Independent predictors of mortality were determined by multivariate logistic regression analysis of variables (demographic characteristics, clinical characteristics, and trauma scores) that differed significantly between survivors and non-survivors. An area under the curve (AUC) analysis was then conducted to identify which trauma score is the most reliable and superior predictor of mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Other: Glasgow coma scale, Other: Hunt-Hess scale, Other: World Federation of Neurological Surgeons (WFNS) scale, Other: modified Fisher scale, Other: VASOGRADE scale, Other: Ogilvy and Carter scaleSurvivors were defined as patients who were still alive after 28 days of admission to the emergency department. |
| Non-survivors | – | Other: Glasgow coma scale, Other: Hunt-Hess scale, Other: World Federation of Neurological Surgeons (WFNS) scale, Other: modified Fisher scale, Other: VASOGRADE scale, Other: Ogilvy and Carter scaleNon-survivors had passed away within 28 days of admission to the emergency department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This multicenter, retrospective, observational cohort study enrolled 451 consecutive adult patients (aged ≥ 18 years) who presented to the emergency departments of the six major and highest-volume tertiary hospitals in Istanbul with non-traumatic Subarachnoid Hemorrhage between September 2020 and September 2023. Data were collected by searching for I60.9 International Classification of Disease (ICD) codes in the hospital's automation systems and archives.
Key inclusion criteria (1 listed)
- patients (aged ≥ 18 years) who presented to the emergency department with non-traumatic Subarachnoid Hemorrhage between September 2020 and September 2023
Key exclusion criteria (5 listed)
- patients younger than 18 years
- patients with missing information
- patients with traumatic SAH
- patients with subdural or epidural hemorrhage
- patients with concurrent ischemic stroke
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 |
|---|---|---|
| Glasgow coma scaleThe levels of response in the components of the Glasgow Coma Scale are 'scored' from 1, for no response, up to normal values of 4 (Eye-opening response) 5 ( Verbal response) and 6 (Motor response) The total Coma Score thus has values between three and 15, three being the worst and 15 being the highest. | Other | Non-survivors, Survivors |
| Hunt-Hess scaleThe Hunt-Hess scale was used to assess SAH severity according to the clinical presentation and the visible neurological deficits. The Grades run from 1 to 5: * Grade 1: Asymptomatic or minimal headache, slight neck stiffness. * Grade 2: Moderate to severe headache, and neck stiffness, but no neurological deficit except cranial nerve palsy. * Grade 3: Drowsiness, confusion, or a mild focal deficit. * Grade 4: Stupor, moderate to severe hemiparesis, early decerebrate rigidity, and vegetative disturbance. * Grade 5: Deep coma, decerebrate rigidity, and a moribund appearance. | Other | Non-survivors, Survivors |
| World Federation of Neurological Surgeons (WFNS) scaleThe World Federation of Neurological Surgeons (WFNS) scale, introduced in 1988, is used to evaluate the clinical severity of patients with SAH. This scale is derived from the GCS score and considers the presence of motor deficits: * Grade 1: GCS score of 15, no motor deficit * Grade 2: GCS score of 13 to 14, no motor deficit * Grade 3: GCS score of 13 to 14, with motor deficit * Grade 4: GCS score of 7 to 12, with or without motor deficit * Grade 5: GCS score of 3 to 6, with or without motor deficit | Other | Non-survivors, Survivors |
| modified Fisher scaleThe modified Fisher scale was used to evaluate SAH severity by reference to the extent of hemorrhage as revealed by CT of the brain. Four grades are depending on the degree of bleeding observed: * Grade 0: No hemorrhage apparent in CT. * Grade 1: Minimal hemorrhage without intraventricular hemorrhage (IVH). * Grade 2: Thin or diffusely thin (<1mm) hemorrhage with bilateral IVH. * Grade 3: Thick (> 1 mm) hemorrhage without bilateral IVH. * Grade 4: Thick (> 1 mm) hemorrhage with bilateral IVH. | Other | Non-survivors, Survivors |
| VASOGRADE scaleThe VASOGRADE scale was established to estimate the risk of delayed cerebral ischemia following SAH. This scale is based on the WFNS and the modified Fisher scales at admission. There are three categories: * Green: WFNS score of 1 or 2 and modified Fisher scale of 1 or 2. * Yellow: WFNS score of 1 or 3 and modified Fisher scale of 3 or 4. * Red: WFNS score of 4 or 5 and any modified Fisher scale score. | Other | Non-survivors, Survivors |
| Ogilvy and Carter scaleThe Ogilvy and Carter scale is a grading system used to predict the outcomes of surgical treatment in patients with SAH due to a ruptured aneurysm. The scale considers multiple factors, including age, Hunt and Hess grade, Fisher grade, and aneurysm size, with a score assigned to each of these variables: * Age greater than 50 * Hunt and Hess grade of 4 to 5 * Fisher grade scores of 3 to 4 * Aneurysm size >10 mm * An additional point is added for a giant posterior circulation aneurysm (≥25 mm) | Other | Non-survivors, Survivors |
Primary outcome
Predictive ability of Glasgow coma scale for 28-day mortality
Time frame: From admission to 28 days
The investigators assessed the predictive ability of Glasgow coma scale in determining 28-day mortality.
Predictive ability of Hunt-Hess scale for 28-day mortality
Time frame: From admission to 28 days
The investigators assessed the predictive ability of Hunt-Hess scale in determining 28-day mortality.
Predictive ability of World Federation of Neurological Surgeons (WFNS) scale for 28-day mortality
Time frame: From admission to 28 days
The investigators assessed the predictive ability of World Federation of Neurological Surgeons (WFNS) scale in determining 28-day mortality.
Predictive ability of modified Fisher scale for 28-day mortality
Time frame: From admission to 28 days
The investigators assessed the predictive ability of modified Fisher scale in determining 28-day mortality.
Predictive ability of VASOGRADE scale for 28-day mortality
Time frame: From admission to 28 days
The investigators assessed the predictive ability of VASOGRADE scale in determining 28-day mortality.
Predictive ability of Ogilvy-Carter rating scale for 28-day mortality
Time frame: From admission to 28 days
The investigators assessed the predictive ability of Ogilvy-Carter rating scale in determining 28-day mortality.
6 secondary outcomes
Predictive ability of Glasgow coma scale for neurological survival
Time frame: From admission to 28 days
Predictive ability of Hunt-Hess scale for neurological survival
Time frame: From admission to 28 days
Predictive ability of World Federation of Neurological Surgeons (WFNS) scale for neurological survival
Time frame: From admission to 28 days
Predictive ability of modified Fisher scale for neurological survival
Time frame: From admission to 28 days
Predictive ability of VASOGRADE scale for neurological survival
Time frame: From admission to 28 days
Predictive ability of Ogilvy-Carter rating scale for neurological survival
Time frame: From admission to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Results publication: PubMed 32986813Sharma D. Perioperative Management of Aneurysmal Subarachnoid Hemorrhage. Anesthesiology. 2020 Dec 1;133(6):1283-1305. doi: 10.1097/ALN.0000000000003558.
- Results publication: PubMed 3176085Hijdra A, van Gijn J, Nagelkerke NJ, Vermeulen M, van Crevel H. Prediction of delayed cerebral ischemia, rebleeding, and outcome after aneurysmal subarachnoid hemorrhage. Stroke. 1988 Oct;19(10):1250-6. doi: 10.1161/01.str.19.10.1250.
- Results publication: PubMed 16159052Rosen DS, Macdonald RL. Subarachnoid hemorrhage grading scales: a systematic review. Neurocrit Care. 2005;2(2):110-8. doi: 10.1385/NCC:2:2:110.
- Results publication: PubMed 9588539Ogilvy CS, Carter BS. A proposed comprehensive grading system to predict outcome for surgical management of intracranial aneurysms. Neurosurgery. 1998 May;42(5):959-68; discussion 968-70. doi: 10.1097/00006123-199805000-00001.
- Results publication: PubMed 10193613Takagi K, Tamura A, Nakagomi T, Nakayama H, Gotoh O, Kawai K, Taneda M, Yasui N, Hadeishi H, Sano K. How should a subarachnoid hemorrhage grading scale be determined? A combinatorial approach based solely on the Glasgow Coma Scale. J Neurosurg. 1999 Apr;90(4):680-7. doi: 10.3171/jns.1999.90.4.0680.
- Results publication: PubMed 28940973Dengler NF, Sommerfeld J, Diesing D, Vajkoczy P, Wolf S. Prediction of cerebral infarction and patient outcome in aneurysmal subarachnoid hemorrhage: comparison of new and established radiographic, clinical and combined scores. Eur J Neurol. 2018 Jan;25(1):111-119. doi: 10.1111/ene.13471. Epub 2017 Nov 2.
- Individual participant dataSharing planned: No. Stored in non-publicly available Available on request
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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.
Adem Az, M.D. principal investigator
Haseki Training and Research Hospital
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 Subarachnoid Hemorrhage, Aneurysmal, run by Haseki Training and Research Hospital 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 20 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive ability of Glasgow coma scale for 28-day mortality (time frame: From admission to 28 days). The study lists 6 primary outcomes in all. 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 NCT06563219, which also lists 6 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 20 Aug 2024.