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Completed

NCT Number: NCT04052646

Prehospital Deaths From Spontaneous Subarachnoid Haemorrhages

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Medical condition: Subarachnoid hemorrhage

Other

We identify patients with the condition of interest and retrospectively collect data on them.

Primary outcomes

  1. Incidence of fatal spontaneous subarachnoid hemorrhage

    Time frame: 2008-2017

    The incidence among the general population.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Development over the years.

    Time frame: 10 years

    Time trends in the incidence of prehospital death from sSAH over the years 2008-2017.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 12, 2019
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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