- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04052646
Prehospital Deaths From Spontaneous Subarachnoid Haemorrhages
Prehospital Deaths From Spontaneous Subarachnoid Hemorrhage; a Retrospective Study Using Autopsy Reports
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Copenhagen, Denmark
- Rigshospitalet
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of fatal spontaneous subarachnoid hemorrhage
Time Frame: 2008-2017
|
The incidence among the general population.
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2008-2017
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health care contacts prior to death.
Time Frame: 72 hours.
|
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.
|
72 hours.
|
Signs of acute illness at the site where the patients died.
Time Frame: 1 hour prior to death
|
Proportion of deceased patients with a history of significant illness immediately before their dead, but without contacting the health care system.
|
1 hour prior to death
|
Emergency Medical Services responses if in contact prior to death.
Time Frame: 72 hours
|
For patients in contact with the Copenhagen Emergency Medical Services, their primary complaint and the initiated response.
|
72 hours
|
Description of the patients that die prior to hospital admission.
Time Frame: 1 day
|
Descriptive characteristics of deceased with respect to age, gender, body mass index and comorbidities.
|
1 day
|
Development over the years.
Time Frame: 10 years
|
Time trends in the incidence of prehospital death from sSAH over the years 2008-2017.
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10 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STPS 3-3013-2985/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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