NCT04052646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 13, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

August 8, 2019

Last Update Submit

April 10, 2020

Conditions

Subarachnoid Hemorrhage

Keywords

Subarachnoid hemorrhageEmergency medical coordination centerEmergency Medical Service

Outcome Measures

Primary Outcomes (1)

  • Incidence of fatal spontaneous subarachnoid hemorrhage

    The incidence among the general population.

    2008-2017

Secondary Outcomes (5)

  • Health care contacts prior to death.

    72 hours.

  • Signs of acute illness at the site where the patients died.

    1 hour prior to death

  • Emergency Medical Services responses if in contact prior to death.

    72 hours

  • Description of the patients that die prior to hospital admission.

    1 day

  • Development over the years.

    10 years

Interventions

Medical condition: Subarachnoid hemorrhageOTHER

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant

Study Record Dates

First Submitted

August 8, 2019

First Posted

August 12, 2019

Study Start

September 13, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)