Predicting 28-Day Mortality in Subarachnoid Hemorrhage

NCT06563219 | Completed DMC

• 1 other identifier: 38-2024
• Study Type: observational
• Target: 451
• Locations: 1 country
• Sites: 1

Brief 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 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.

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; 28-day mortality

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Predictive ability of Glasgow coma scale for neurological survival

  From admission to 28 days

• Predictive ability of Hunt-Hess scale for neurological survival

  From admission to 28 days

• Predictive ability of World Federation of Neurological Surgeons (WFNS) scale for neurological survival

  From admission to 28 days

• Predictive ability of modified Fisher scale for neurological survival

  From admission to 28 days

• Predictive ability of VASOGRADE scale for neurological survival

  From admission to 28 days

Study Arms (2)

Survivors

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

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.

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

Interventions

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.

Non-survivors; Survivors

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.

Non-survivors; Survivors

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

Non-survivors; Survivors

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.

Non-survivors; Survivors

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.

Non-survivors; Survivors

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)

Non-survivors; Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Fatih, 34265, Turkey (Türkiye)

Location

Related Publications (6)

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

  PMID: 32986813 RESULT

• 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.

  PMID: 3176085 RESULT

• 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.

  PMID: 16159052 RESULT

• 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.

  PMID: 9588539 RESULT

• 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.

  PMID: 10193613 RESULT

• 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.

  PMID: 28940973 RESULT

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Glasgow Coma Scale; Weights and Measures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Trauma Severity Indices; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Adem Az, M.D.

  Haseki Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: August 20, 2024
• Study Start: September 1, 2020
• Primary Completion: September 1, 2023
• Study Completion: August 1, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)