Prehospital Deaths From Spontaneous Subarachnoid Haemorrhages

Subarachnoid Hemorrhage Clinical Trial

Official title:

Prehospital Deaths From Spontaneous Subarachnoid Hemorrhage; a Retrospective Study Using Autopsy Reports

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052646
• Other study ID #: STPS 3-3013-2985/1
• Status: Completed
• Start date: September 13, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Other:
• Medical condition: Subarachnoid hemorrhage
We identify patients with the condition of interest and retrospectively collect data on them.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of fatal spontaneous subarachnoid hemorrhage	The incidence among the general population.	2008-2017
Secondary	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.	72 hours.
Secondary	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.	1 hour prior to death
Secondary	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.	72 hours
Secondary	Description of the patients that die prior to hospital admission.	Descriptive characteristics of deceased with respect to age, gender, body mass index and comorbidities.	1 day
Secondary	Development over the years.	Time trends in the incidence of prehospital death from sSAH over the years 2008-2017.	10 years