Clinical trial NCT06563219: Predicting 28-Day Mortality in Subarachnoid Hemorrhage
Official title: Comparative Analysis of Traditional Clinical Scores and Combined Grading Systems in Predicting 28-Day Mortality in Non-Traumatic Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictive ability of Glasgow coma scale for 28-day mortality
timeFrame: From admission to 28 days
measure: Predictive ability of Hunt-Hess scale for 28-day mortality
timeFrame: From admission to 28 days
measure: Predictive ability of World Federation of Neurological Surgeons (WFNS) scale for 28-day mortality
timeFrame: From admission to 28 days
measure: Predictive ability of modified Fisher scale for 28-day mortality
timeFrame: From admission to 28 days
measure: Predictive ability of VASOGRADE scale for 28-day mortality
timeFrame: From admission to 28 days
measure: Predictive ability of Ogilvy-Carter rating scale for 28-day mortality
timeFrame: From admission to 28 days
Secondary outcomes:
measure: Predictive ability of Glasgow coma scale for neurological survival
timeFrame: From admission to 28 days
measure: Predictive ability of Hunt-Hess scale for neurological survival
timeFrame: From admission to 28 days
measure: Predictive ability of World Federation of Neurological Surgeons (WFNS) scale for neurological survival
timeFrame: From admission to 28 days
measure: Predictive ability of modified Fisher scale for neurological survival
timeFrame: From admission to 28 days
measure: Predictive ability of VASOGRADE scale for neurological survival
timeFrame: From admission to 28 days
measure: Predictive ability of Ogilvy-Carter rating scale for neurological survival
timeFrame: From admission to 28 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
state: Fatih
Study officials:
affiliation: Haseki Training and Research Hospital
name: Adem Az, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharma D. Perioperative Management of Aneurysmal Subarachnoid Hemorrhage. Anesthesiology. 2020 Dec 1;133(6):1283-1305. doi: 10.1097/ALN.0000000000003558.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.