CClinicalTrials.gg
CompletedNCT06490640Updated Jul 8, 2024

Factors Influencing the Mortality of Patients With Subarachnoid Haemorrhage

An observational study in Spontaneous Subarachnoid Hemorrhage, sponsored by Melike Cengiz. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-08.

Sponsored by Melike Cengiz · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
117
Ages
18 Years and older
Sex
All
01

Study summary

Spontaneous subarachnoid haemorrhage (SAH) is a serious cerebrovascular disease with high morbidity and mortality.Determining the factors associated with mortality in the ICU follow-up and treatment of patients with spontaneous SAH is very important for clarifying these uncertainties and improving ICU outcomes.In the literature, there are very few studies analysing ICU mortality and mortality-related factors in this patient group.The aim of this study was to determine the demographic/clinical characteristics and factors affecting the mortality of spontaneous SAH patients admitted in the ICU.

Read the detailed description

Patients aged 18 years and older who were diagnosis of spontaneous SAH and admitted the ICU were included in the study. The diagnosis of spontaneous SAH was based on the brain computed tomography (CT) or lumbar puncture. Patients with a final outcome (survival or mortality) in our centre were included in the analysis were included. Only patients admitted to the ICU for the first time were included. Patients with traumatic SAH, history of significant head trauma in the previous two weeks (any abnormality on brain CT requiring hospitalisation for more than 24 hours), pregnancy and length of ICU stay ≤24 hours were excluded.The clinical and radiological severity of the patients at ICU admission was according to Acute Physiological and Chronic Health Evaluation-II score (APACHE II), Glasgow Coma Scale (GCS), Modified Fisher Scale, World Federation of Neurological Societies (WFNS) and Hunt and Hess (H\&H) grading systems.Demographic and clinical data derived and analyzed included age, sex, smoking history, comorbidities. Presenting signs and symptoms, diagnoses responsible for spontaneous SAH (aneurysm, arterial malformation, etc.), site of aneurysm, risk factors, location of the aneurysm, risk factors, blood pressure during ICU admission, and scores from grading systems indicating clinical and radiological severity of the disease were recorded. Procedures for spontaneous SAH, complications during ICU follow-up (vasospasm, meningitis, electrolyte disturbances, rebleeding, DCI, VIP, sepsis/septic shock) and treatments, duration of ICU stay and mechanical ventilation, ICU outcome (survival or mortality), causes of mortality and brain death status were recorded. According to the outcome of the ICU process, the patients were divided into two groups as survival and mortality.

02

Conditions studied

  • Spontaneous Subarachnoid Hemorrhage

Keywords

  • Intensive Care Unit
  • Mortality
  • Spontaneous subarachnoid haemorrhage
03

In context

Subarachnoid Hemorrhage

509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.

This study's enrollment of 117 is close to the median of 117 across 226 observational studies indexed under Subarachnoid Hemorrhage.

Browse Subarachnoid Hemorrhage studies →

Lead sponsor

Melike Cengiz is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients aged 18 years and older who were diagnosis of spontaneous SAH and admitted the intensive care unit were included in the study.

Inclusion criteria

  • Patients aged ≥18 years with a confrmed diagnosis of spontaneous subarachnoid haemorrhage by a brain computed tomography (CT)
  • Patients with a final outcome (survival or mortality) in our centre

Exclusion criteria

Exclusion Criteria:

  • Patients with traumatic SAH
  • History of significant head trauma in the previous two weeks (any abnormality on brain CT requiring hospitalisation for more than 24 hours)
  • Pregnancy
  • Length of intensive care unit stay ≤24 hours
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
117 participants (actual)
Patient registry
No

Groups and cohorts

  • Spontaneous subarachnoid haemorrhage survival cohort

    Demographic and clinical data derived and analyzed included age, sex, smoking history, comorbidities. Presenting signs and symptoms, diagnoses responsible for spontaneous SAH (aneurysm, arterial malformation, etc.), site of aneurysm, risk factors, location of the aneurysm, risk factors, blood pressure during ICU admission, and scores from grading systems indicating clinical and radiological severity of the disease were recorded. Procedures for spontaneous SAH, complications during ICU follow-up (vasospasm, meningitis, electrolyte disturbances, rebleeding, DCI, VIP, sepsis/septic shock) and treatments, duration of ICU stay and mechanical ventilation, ICU outcome (survival or mortality), causes of mortality and brain death status were recorded.

    Other: Spontaneous subarachnoid haemorrhage survival cohort

  • Spontaneous subarachnoid haemorrhage mortality cohort

    Demographic and clinical data derived and analyzed included age, sex, smoking history, comorbidities. Presenting signs and symptoms, diagnoses responsible for spontaneous SAH (aneurysm, arterial malformation, etc.), site of aneurysm, risk factors, location of the aneurysm, risk factors, blood pressure during ICU admission, and scores from grading systems indicating clinical and radiological severity of the disease were recorded. Procedures for spontaneous SAH, complications during ICU follow-up (vasospasm, meningitis, electrolyte disturbances, rebleeding, DCI, VIP, sepsis/septic shock) and treatments, duration of ICU stay and mechanical ventilation, ICU outcome (survival or mortality), causes of mortality and brain death status were recorded.

    Other: Spontaneous subarachnoid haemorrhage mortality cohort

Interventions

  • OtherSpontaneous subarachnoid haemorrhage survival cohort

    consists of surviving patients

  • OtherSpontaneous subarachnoid haemorrhage mortality cohort

    consists of deceased patients

06

What researchers measure

Primary outcomes

  1. determine mortality and causes

    determine mortality and its causes in patients with spontaneous subarachnoid haemorrhage

    Time frame: 01 January 2019-31 December 2023

Secondary outcomes

  1. factors affecting mortality

    evaluate the clinical characteristics and factors affecting mortality in subarachnoid haemorrhage

    Time frame: 01 January 2019-31 December 2023

07

Study locations

1 site
  • Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
    Antalya, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06490640
Lead sponsor
Melike Cengiz
Responsible party
Melike Cengiz (MD,Professor Doctor, Akdeniz University) — Sponsor-investigator
First posted
Jul 8, 2024
Start date
Mar 1, 2024
Primary completion
May 1, 2024
Completion
Jun 15, 2024
Last update
Jul 8, 2024

Study contacts

Ulku Arslan Yildiz, MD
principal investigator · Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
Murat Yilmaz, Professor
principal investigator · Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
Onur Cetinkaya, MD
principal investigator · Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion