Subarachnoid HemorrhageNCT04052646
Prehospital Deaths From Spontaneous Subarachnoid Haemorrhages
An observational study of Subarachnoid Hemorrhage, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
In this study we aim to determine the incidence of fatal spontaneous subarachnoid haemorrhage outside hospital. Also, we aim to investigate these patient´s pattern of contact to the health care system immediately before their death and to describe the circumstances under which they died. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Medical condition: Subarachnoid hemorrhage
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Sep 2019to 31 Jan 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Department of Forensic Medicine conducts medicolegal investigations on request by the police in cases of sudden death of unknown causes in eastern Denmark.
Who may be able to join
- Must be registered at the Department of Forensic Medicine with spontaneous subarachnoid hemorrhage as the cause of death, deceased between 2008 and 2017, and found in the Capital Region of Denmark.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prehospital Deaths From Spontaneous Subarachnoid Hemorrhage; a Retrospective Study Using Autopsy Reports
In this study we aim to determine the incidence of fatal spontaneous subarachnoid haemorrhage outside hospital. Also, we aim to investigate these patient´s pattern of contact to the health care system immediately before their death and to describe the circumstances under which they died.
Read the detailed description
Sudden death due to spontaneous subarachnoid hemorrhage (sSAH) has been known for decades. An older metaanalysis found a combined overall risk of sudden death from sSAH of 12.4% (the individual studies reported incidences of 3-21%). In a recent study 98 out of 445 patients with sSAH died in the prehospital phase. In addition to the high proportion of sSAH-patients that die, they are also much younger than those who die from intracerebral hemorrhage; the median age of sSAH-patients that die suddenly is 54 years versus 71 years among patients with intracerebral hemorrhage. Predictors for sudden death have been found to include living alone, smoking and high systolic blood pressure, as well as hemorrhage in the posterior circulation.
While some patients may die at onset of the hemorrhage, others may have experienced symptoms longer. The clinical presentation of sSAH varies and some studies report as little as 40% of patients to have presented with classic textbook symptoms. Half are initially in an intact neurological state. These patients may have been in contact with the health care system but not admitted.
In recent years the Copenhagen Emergency Medical Coordinations Center has implemented an electronic decision support tool. If this has reduced the proportion of patients with sSAH that die outside hospital is unknown.
Primary aim:
The primary aim of this study is to determine the incidence of fatal spontaneous subarachnoid hemorrhage in the Capital Region of Denmark, before being admitted to hospital.
Secondary analyses:
- Proportion of deceased patients that have been in contact with a general practitioner, on-call general practitioner, the Copenhagen Emergency Medical Services or admitted to hospital within 72 hours of their death.
- Proportion of deceased patients with a history of significant illness immediately before their dead, but without contacting the health care system.
- For patients in contact with the Copenhagen Emergency Medical Services, their primary complaint and the initiated response.
- Descriptive characteristics of deceased with respect to age, gender, body mass index and comorbidities.
- Time trends in the incidence of prehospital death from sSAH over the years 2008-2017.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Medical condition: Subarachnoid hemorrhage
- Keywords
- Subarachnoid hemorrhage, Emergency medical coordination center, Emergency Medical Service
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical condition: Subarachnoid hemorrhageOther
We identify patients with the condition of interest and retrospectively collect data on them.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of fatal spontaneous subarachnoid hemorrhage
The incidence among the general population.
Measured: 2008-2017
Secondary outcomes (5)
Health care contacts prior to death.
Proportion of deceased patients that have been in contact with a general practitioner, on-call general practitioner, the Copenhagen Emergency Medical Services or admitted to hospital within 72 hours of their death.
Measured: 72 hours.
Signs of acute illness at the site where the patients died.
Proportion of deceased patients with a history of significant illness immediately before their dead, but without contacting the health care system.
Measured: 1 hour prior to death
Emergency Medical Services responses if in contact prior to death.
For patients in contact with the Copenhagen Emergency Medical Services, their primary complaint and the initiated response.
Measured: 72 hours
Description of the patients that die prior to hospital admission.
Descriptive characteristics of deceased with respect to age, gender, body mass index and comorbidities.
Measured: 1 day
Development over the years.
Time trends in the incidence of prehospital death from sSAH over the years 2008-2017.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start13 Sep 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Asger Sonne, MD, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052646
- Sponsor's protocol ID
- STPS 3-3013-2985/1
- Status last verified
- Apr 2020
- First submitted
- 8 Aug 2019
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Deaths From Spontaneous Subarachnoid Hemorrhage; a Retrospective Study Using Autopsy Reports
- ClinicalTrials.gov ID
- NCT04052646
- Acronym / sponsor ID
- STPS 3-3013-2985/1
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid hemorrhage, Emergency medical coordination center, Emergency Medical Service
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 12 Aug 2019 (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.
In this study we aim to determine the incidence of fatal spontaneous subarachnoid haemorrhage outside hospital. Also, we aim to investigate these patient´s pattern of contact to the health care system immediately before their death and to describe the circumstances under which they died.
Detailed description
Sudden death due to spontaneous subarachnoid hemorrhage (sSAH) has been known for decades. An older metaanalysis found a combined overall risk of sudden death from sSAH of 12.4% (the individual studies reported incidences of 3-21%). In a recent study 98 out of 445 patients with sSAH died in the prehospital phase. In addition to the high proportion of sSAH-patients that die, they are also much younger than those who die from intracerebral hemorrhage; the median age of sSAH-patients that die suddenly is 54 years versus 71 years among patients with intracerebral hemorrhage. Predictors for sudden death have been found to include living alone, smoking and high systolic blood pressure, as well as hemorrhage in the posterior circulation.
While some patients may die at onset of the hemorrhage, others may have experienced symptoms longer. The clinical presentation of sSAH varies and some studies report as little as 40% of patients to have presented with classic textbook symptoms. Half are initially in an intact neurological state. These patients may have been in contact with the health care system but not admitted.
In recent years the Copenhagen Emergency Medical Coordinations Center has implemented an electronic decision support tool. If this has reduced the proportion of patients with sSAH that die outside hospital is unknown.
Primary aim:
The primary aim of this study is to determine the incidence of fatal spontaneous subarachnoid hemorrhage in the Capital Region of Denmark, before being admitted to hospital.
Secondary analyses:
- Proportion of deceased patients that have been in contact with a general practitioner, on-call general practitioner, the Copenhagen Emergency Medical Services or admitted to hospital within 72 hours of their death.
- Proportion of deceased patients with a history of significant illness immediately before their dead, but without contacting the health care system.
- For patients in contact with the Copenhagen Emergency Medical Services, their primary complaint and the initiated response.
- Descriptive characteristics of deceased with respect to age, gender, body mass index and comorbidities.
- Time trends in the incidence of prehospital death from sSAH over the years 2008-2017.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Department of Forensic Medicine conducts medicolegal investigations on request by the police in cases of sudden death of unknown causes in eastern Denmark.
Key inclusion criteria (1 listed)
- Must be registered at the Department of Forensic Medicine with spontaneous subarachnoid hemorrhage as the cause of death, deceased between 2008 and 2017, and found in the Capital Region of Denmark.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Medical condition: Subarachnoid hemorrhageWe identify patients with the condition of interest and retrospectively collect data on them. | Other | – |
Primary outcome
Incidence of fatal spontaneous subarachnoid hemorrhage
Time frame: 2008-2017
The incidence among the general population.
5 secondary outcomes
Health care contacts prior to death.
Time frame: 72 hours.
Signs of acute illness at the site where the patients died.
Time frame: 1 hour prior to death
Emergency Medical Services responses if in contact prior to death.
Time frame: 72 hours
Description of the patients that die prior to hospital admission.
Time frame: 1 day
Development over the years.
Time frame: 10 years
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 13 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Subarachnoid Hemorrhage
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Subarachnoid Hemorrhage, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 1 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 13 Apr 2020. 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 Denmark. 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?
Incidence of fatal spontaneous subarachnoid hemorrhage (time frame: 2008-2017). 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 13 Apr 2020.