Predicting 28-Day Mortality in Subarachnoid Hemorrhage

NCT ID: NCT06563219

Last Updated: 2024-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

451 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2024-08-01

Brief Summary

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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

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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

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Subarachnoid Hemorrhage, Aneurysmal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Survivors

Survivors were defined as patients who were still alive after 28 days of admission to the emergency department.

Glasgow coma scale

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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)

Non-survivors

Non-survivors had passed away within 28 days of admission to the emergency department.

Glasgow coma scale

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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)

Interventions

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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.

Intervention Type 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.

Intervention Type 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

Intervention Type 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.

Intervention Type 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.

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haseki Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Adem Az

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adem Az, M.D.

Role: PRINCIPAL_INVESTIGATOR

Haseki Training and Research Hospital

Locations

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Haseki Training and Research Hospital

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Sharma D. Perioperative Management of Aneurysmal Subarachnoid Hemorrhage. Anesthesiology. 2020 Dec 1;133(6):1283-1305. doi: 10.1097/ALN.0000000000003558.

Reference Type RESULT
PMID: 32986813 (View on PubMed)

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.

Reference Type RESULT
PMID: 3176085 (View on PubMed)

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.

Reference Type RESULT
PMID: 16159052 (View on PubMed)

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.

Reference Type RESULT
PMID: 9588539 (View on PubMed)

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.

Reference Type RESULT
PMID: 10193613 (View on PubMed)

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.

Reference Type RESULT
PMID: 28940973 (View on PubMed)

Other Identifiers

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38-2024

Identifier Type: -

Identifier Source: org_study_id

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