NCT03786068

Brief Summary

Spontaneous subarachnoid haemorrhages (SAH) are a particularly severe type of stroke with a tendency to affect younger individuals than other types of stroke. The condition is time critical as early neurosurgical treatment is needed. The aim of this study is to determine the delay from when a patient with SAH calls the Emergency Medical Services (EMS) to they are admitted to a neurosurgical department. Further, it is the aim to determine predictors for increased delay and to examine the accuracy of the triage tool used by the EMS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

December 13, 2018

Last Update Submit

May 10, 2019

Conditions

Spontaneous Subarachnoid Hemorrhage

Keywords

Emergency Medical ServicesPrehospitalTime to admissionTime to neurosurgeryTreatment delay

Outcome Measures

Primary Outcomes (2)

  • Time from first contact to the Copenhagen Emergency Medical Communications Center to admission to a neurosurgical department in patients with spontaneous subarachnoid haemorrhage.

    For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of time to admission is performed.

  • To identify predictors for short time to neurosurgical department.

    In a logistic regression model with time \>/\<4 hours as the dependent variable the following possible predictors are tested: Classic headache (yes/no), age (years), gender (m/f), person who is making the emergency call (patient/bystander).

    For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of emergency medical telephone calls is performed.

Secondary Outcomes (4)

  • The proportion of patients with ´acute severe headache´, that are admitted to a neurosurgical department within four hours of initial contact to the EMCC.

    For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of time to admission is performed.

  • Sensitivity and positive predictive value of the Danish Index category ´acute severe headache´ for sSAH.

    For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of symptoms described in the emergency medical telephone call is performed.

  • Sensitivity and positive predictive value for sSAH of symptoms other than ´acute severe headache´ in the Danish Index.

    For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of symptoms described in the emergency medical telephone call is performed.

  • The proportion of emergency calls from sSAH-patients, that trigger a level A response, regardless of which symptom category it is triggered by.

    For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of actived responses from the Emergecny Medical Coordination Center is performed.

Eligibility Criteria

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

All patients registered with spontaneous subarachnoid haemorrhage (International Classification of Disease version 10 diagnoses DI60-DI60.9) in the Danish National Patient Register, admitted to a hospital in the Capital Region of Denmark between 1 May 2011 - 31 December 2014, aged ≥18 years on admission are registered in this database. Patients diagnoses were validated by medical record review.

You may qualify if:

  • Patients with first-time spontaneous subarachnoid haemorrhage in the Capital Region of Denmark between 1 May 2011 and 31 December 2014 and contact to the Copenhagen EMCC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

  • Sonne A, Andersen JB, Eskesen V, Lippert F, Waldorff FB, Bang CW, Siersma V, Lohse N, Rasmussen LS. Criteria-based dispatch of emergency medical services in non-traumatic subarachnoid haemorrhage. Dan Med J. 2021 Aug 17;68(9):A02210152.

    PMID: 34477094DERIVED

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
COHORT
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant

Study Record Dates

First Submitted

December 13, 2018

First Posted

December 24, 2018

Study Start

January 21, 2019

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations

DK(1)