Spontaneous Subarachnoid HemorrhageNCT06490640
Factors Influencing the Mortality of Patients With Subarachnoid Haemorrhage
An observational study of Spontaneous Subarachnoid Hemorrhage, run by Melike Cengiz at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Subarachnoid Hemorrhage
- What is being tested?
- Spontaneous subarachnoid haemorrhage survival cohort and Spontaneous subarachnoid haemorrhage mortality cohort
- How many people
- 117 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
Antalya
About this study
Official title: Factors Influencing the Mortality of Patients With Subarachnoid Haemorrhage in the Intensive Care Unit
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.
- Conditions
- Spontaneous Subarachnoid Hemorrhage
- Being tested
- Spontaneous subarachnoid haemorrhage survival cohort, Spontaneous subarachnoid haemorrhage mortality cohort
- Keywords
- Intensive Care Unit, Mortality, Spontaneous subarachnoid haemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous subarachnoid haemorrhage survival cohortOther
consists of surviving patients
Spontaneous subarachnoid haemorrhage mortality cohortOther
consists of deceased patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Spontaneous subarachnoid haemorrhage mortality cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine mortality and causes
determine mortality and its causes in patients with spontaneous subarachnoid haemorrhage
Measured: 01 January 2019-31 December 2023
Secondary outcomes (1)
factors affecting mortality
evaluate the clinical characteristics and factors affecting mortality in subarachnoid haemorrhage
Measured: 01 January 2019-31 December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Mar 2024
- Primary completion1 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melike Cengiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melike Cengiz, Akdeniz University
- Investigators
- Ulku Arslan Yildiz, MD, Principal investigator, Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, TurkeyMurat Yilmaz, Professor, Principal investigator, Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, TurkeyOnur Cetinkaya, MD, Principal investigator, Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490640
- Sponsor's protocol ID
- Akdeniz U.
- Status last verified
- Jun 2024
- First submitted
- 29 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Mortality of Patients With Subarachnoid Haemorrhage in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06490640
- Acronym / sponsor ID
- Akdeniz U.
- Conditions
- Spontaneous Subarachnoid Hemorrhage
- Keywords
- Intensive Care Unit, Mortality, Spontaneous subarachnoid haemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Melike CengizUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous subarachnoid haemorrhage survival cohort | – | Other: Spontaneous subarachnoid haemorrhage survival cohortDemographic 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. |
| Spontaneous subarachnoid haemorrhage mortality cohort | – | Other: Spontaneous subarachnoid haemorrhage mortality cohortDemographic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spontaneous subarachnoid haemorrhage survival cohortconsists of surviving patients | Other | Spontaneous subarachnoid haemorrhage survival cohort |
| Spontaneous subarachnoid haemorrhage mortality cohortconsists of deceased patients | Other | Spontaneous subarachnoid haemorrhage mortality cohort |
Primary outcome
determine mortality and causes
Time frame: 01 January 2019-31 December 2023
determine mortality and its causes in patients with spontaneous subarachnoid haemorrhage
1 secondary outcome
factors affecting mortality
Time frame: 01 January 2019-31 December 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Subarachnoid Hemorrhage, run by Melike Cengiz at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine mortality and causes (time frame: 01 January 2019-31 December 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.