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Completed

NCT Number: NCT06563219

Predicting 28-Day Mortality in 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.

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Key information

Conditions

Subarachnoid Hemorrhage, Aneurysmal Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haseki Training and Research Hospital

Istanbul, Fatih, 34265, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glasgow coma scale

Other

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 scale

Other

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) scale

Other

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 scale

Other

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 scale

Other

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 scale

Other

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)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

Comparative Analysis of Traditional Clinical Scores and Combined Grading Systems in Predicting 28-Day Mortality in Non-Traumatic Subarachnoid Hemorrhage

Acronym: SAHstdy

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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