NCT03980613

Brief Summary

It is the primary aim of this study to identify symptoms and/or specific words (trigger words) indicative of spontaneous subarachnoid haemorrhage (sSAH) during emergency telephone calls to the Emergency Medical Service Copenhagen (EMS). Further, it is the aim to determine the association between the symptoms/trigger words and sSAH, the sensitivity of the symptoms/trigger words and finally, to identify factors in the telephone visitation that may influence the level of activated prehospital response

Trial Health

87
On Track

Trial Health Score

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

Enrollment
892

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 26, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

June 4, 2019

Last Update Submit

February 24, 2021

Conditions

Keywords

Emergency Medical ServiceTriageTelephone visitation

Outcome Measures

Primary Outcomes (1)

  • Proportions of patients with each symptom

    The proportions of patients presenting with each identified symptom and/or trigger word described during emergency telephone calls, among patients with first-ever sSAH.

    Day 0

Secondary Outcomes (3)

  • Odds ratios for having sSAH for each symptom identified under the primary outcome.

    Day 0

  • Sensitivity of each symptom.

    Day 0

  • Emergency telephone call predictors for dispatching ambulances with the highest priority level.

    Day 0

Study Arms (2)

Spontaneous subarachnoid haemorrhage

Patients with verified spontaneous subarachnoid haemorrhage that have called the emergency medical service Copenhagen.

Other: Triage

Controls

Patients without spontaneous subarachnoid haemorrhage that have called the emergency medical service Copenhagen.

Other: Triage

Interventions

TriageOTHER

Emergency telephone calls from cases and controls are replayed and analyzed for symptom descriptions indicating spontaneous subarachnoid haemorrhage.

ControlsSpontaneous subarachnoid haemorrhage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People aged 18 years or older with a Danish Central Person Register-number (CPR-number), living, working or visiting the Capital Region of Denmark between January 1, 2014 and December 31, 2018.

You may qualify if:

  • Having called the emergency medical service Copenhagen between January 1, 2014 and December 31, 2018.
  • Must have a Danish Central Person Register-number.
  • Cases must be first-ever subarachnoid haemorrhages.
  • Cases must have survived to admission.

You may not qualify if:

  • Patients transferred to a to a hospital in the Capital Region of Denmark from abroad or from another Danish geopolitical region.
  • Subarachnoid haemorrhages that have occurred during hospitalization are also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

  • Sonne A, Egholm S, Elgaard L, Breindahl N, Jensen AH, Eskesen V, Lippert F, Waldorff FB, Lohse N, Rasmussen LS. Symptoms presented during emergency telephone calls for patients with spontaneous subarachnoid haemorrhage. Scand J Trauma Resusc Emerg Med. 2021 Aug 16;29(1):118. doi: 10.1186/s13049-021-00934-x.

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Triage

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Emergency Medical ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lars S Rasmussen, Professor

    Rigshospitalet, Capital Region of Denmark

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 10, 2019

Study Start

August 26, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 25, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations