Predicting 28-Day Mortality in Subarachnoid Hemorrhage (SAHstdy)

August 17, 2024 updated by: Adem Az, Haseki Training and Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
451

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34265
        • Haseki Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • patients (aged ≥ 18 years) who presented to the emergency department with non-traumatic Subarachnoid Hemorrhage between September 2020 and September 2023

Exclusion Criteria:

  • patients younger than 18 years
  • patients with missing information
  • patients with traumatic SAH
  • patients with subdural or epidural hemorrhage
  • patients with concurrent ischemic stroke

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Survivors
Survivors were defined as patients who were still alive after 28 days of admission to the emergency department.
Other: Glasgow coma scale
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.
Other: Hunt-Hess scale

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.
Other: World Federation of Neurological Surgeons (WFNS) scale

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
Other: modified Fisher scale

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.
Other: VASOGRADE scale

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.
Other: Ogilvy and Carter scale

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)
Non-survivors
Non-survivors had passed away within 28 days of admission to the emergency department.
Other: Glasgow coma scale
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.
Other: Hunt-Hess scale

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.
Other: World Federation of Neurological Surgeons (WFNS) scale

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
Other: modified Fisher scale

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.
Other: VASOGRADE scale

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.
Other: Ogilvy and Carter scale

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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From admission to 28 days
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.
From admission to 28 days
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.
From admission to 28 days
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.
From admission to 28 days
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.
From admission to 28 days
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.
From admission to 28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Predictive ability of Glasgow coma scale for neurological survival
Time Frame: From admission to 28 days
The investigators assessed the predictive ability of Glasgow coma scale in determining neurological survival
From admission to 28 days
Predictive ability of Hunt-Hess scale for neurological survival
Time Frame: From admission to 28 days
The investigators assessed the predictive ability of Hunt-Hess scale in determining neurological survival
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
The investigators assessed the predictive ability of World Federation of Neurological Surgeons (WFNS) scale in determining neurological survival
From admission to 28 days
Predictive ability of modified Fisher scale for neurological survival
Time Frame: From admission to 28 days
The investigators assessed the predictive ability of modified Fisher scale in determining neurological survival
From admission to 28 days
Predictive ability of VASOGRADE scale for neurological survival
Time Frame: From admission to 28 days
The investigators assessed the predictive ability of VASOGRADE scale in determining neurological survival
From admission to 28 days
Predictive ability of Ogilvy-Carter rating scale for neurological survival
Time Frame: From admission to 28 days
The investigators assessed the predictive ability of Ogilvy-Carter rating scale in determining neurological survival
From admission to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haseki Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adem Az, M.D., Haseki Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Stored in non-publicly available Available on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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