NCT06490640

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
Last Updated

July 8, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 29, 2024

Last Update Submit

June 29, 2024

Conditions

Keywords

Intensive Care UnitMortalitySpontaneous subarachnoid haemorrhage

Outcome Measures

Primary Outcomes (1)

  • determine mortality and causes

    determine mortality and its causes in patients with spontaneous subarachnoid haemorrhage

    01 January 2019-31 December 2023

Secondary Outcomes (1)

  • factors affecting mortality

    01 January 2019-31 December 2023

Study Arms (2)

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

consists of surviving patients

Spontaneous subarachnoid haemorrhage survival cohort

consists of deceased patients

Spontaneous subarachnoid haemorrhage mortality cohort

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ulku Arslan Yildiz, MD

    Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

    PRINCIPAL INVESTIGATOR
  • Murat Yilmaz, Professor

    Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

    PRINCIPAL INVESTIGATOR
  • Onur Cetinkaya, MD

    Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD,Professor Doctor

Study Record Dates

First Submitted

June 29, 2024

First Posted

July 8, 2024

Study Start

March 1, 2024

Primary Completion

May 1, 2024

Study Completion

June 15, 2024

Last Updated

July 8, 2024

Record last verified: 2024-06

Locations