Predicting 28-Day Mortality in Subarachnoid Hemorrhage (SAHstdy)

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: Completed
• Conditions: Subarachnoid Hemorrhage, Aneurysmal
• Intervention / Treatment: 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

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: Observational
• Enrollment (Actual): 451

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	From admission to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive ability of Glasgow coma scale for neurological survival	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	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	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	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	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	The investigators assessed the predictive ability of Ogilvy-Carter rating scale in determining neurological survival	From admission to 28 days

Collaborators and Investigators

• Sponsor: Haseki Training and Research Hospital
• Investigators: Principal Investigator: Adem Az, M.D., Haseki Training and Research Hospital

Publications and helpful links

General Publications

• Sharma D. Perioperative Management of Aneurysmal Subarachnoid Hemorrhage. Anesthesiology. 2020 Dec 1;133(6):1283-1305. doi: 10.1097/ALN.0000000000003558. Erratum In: Anesthesiology. 2021 Apr 1;134(4):672. doi: 10.1097/ALN.0000000000003721.
• Hijdra 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.
• Rosen DS, Macdonald RL. Subarachnoid hemorrhage grading scales: a systematic review. Neurocrit Care. 2005;2(2):110-8. doi: 10.1385/NCC:2:2:110.
• Ogilvy 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.
• Takagi 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.
• Dengler 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: August 17, 2024
• First Submitted That Met QC Criteria: August 17, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 17, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Subarachnoid Hemorrhage; Glasgow coma scale; Aneurysmal; 28-day mortality; Non-traumatic; World federation of neurological surgeons scale; modified Fisher scale; VASOGRADE scale; Ogilvy-Carter scale
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID 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