Prehospital Deaths From Spontaneous Subarachnoid Haemorrhages

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT04052646
Collaborator
University of Copenhagen (Other)
58
1
4.6
12.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Medical condition: Subarachnoid hemorrhage

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

Study Type:
Observational
Actual Enrollment :
58 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Prehospital Deaths From Spontaneous Subarachnoid Hemorrhage; a Retrospective Study Using Autopsy Reports
Actual Study Start Date :
Sep 13, 2019
Actual Primary Completion Date :
Jan 31, 2020
Actual Study Completion Date :
Jan 31, 2020

Outcome Measures

Primary Outcome Measures

  1. Incidence of fatal spontaneous subarachnoid hemorrhage [2008-2017]

    The incidence among the general population.

Secondary Outcome Measures

  1. Health care contacts prior to death. [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. [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. [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. [1 day]

    Descriptive characteristics of deceased with respect to age, gender, body mass index and comorbidities.

  5. Development over the years. [10 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet Copenhagen Denmark

Sponsors and Collaborators

  • Rigshospitalet, Denmark
  • University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asger Sonne, MD, Clinical assistant, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT04052646
Other Study ID Numbers:
  • STPS 3-3013-2985/1
First Posted:
Aug 12, 2019
Last Update Posted:
Apr 13, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Asger Sonne, MD, Clinical assistant, Rigshospitalet, Denmark
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2020