NCT04377347

Brief Summary

For patients with spontaneous subarachnoid haemorrhage, it remains to be investigated if there is an association between the time from patients call the Emergence Medical Coordination Center to neurosurgical admission and long-term outcome. This is a retrospective cohort study with four-year followup. The primary aim is to determine if the time to neurosurgical admission is associated to labour marked affiliation and mortality after four years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
537

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

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

Study Start

First participant enrolled

May 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

May 2, 2020

Last Update Submit

February 24, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Labour marked affiliation and mortality

    The incidence of all-cause death and early retirement over the four-years after sSAH for different times to treatment is shown with Kaplan-Meier plots, and assessed with log-rank tests.

    4 years

Study Arms (1)

Confirmed spontaneous subarachnoid haemorrhage

Patients, minimum 18 years of age, identified with the diagnosis in the Danish National Patient Register. The diagnosis is verified by medical record review. All patients were initially admitted to a hospital in the Capital Region of Denmark. In a national labour marked register and the civil registration register the patients are then followed for four years.

Other: Time

Interventions

TimeOTHER

Exposure is the time from patients call the Emergency Medical Coordination Center to they are admitted to a neurosurgiocal department.

Confirmed spontaneous subarachnoid haemorrhage

Eligibility Criteria

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

Patients that are retired or on social transfer payments the last three months before the sSAH are excluded from analyses on retirement and labour marked affiliation. However, they are included in mortality analyses. Also, patients aged 60 years or older are excluded in analyses of early retirement as reduced work capacity may to a higher degree result in early voluntary retirement.

You may qualify if:

  • Spontaneous subarachnoid haemorrhage registered in the Danish National Patient Register and confirmed by medical record review.
  • Initially admitted to a hospital in the Capital Region of Denmark between 1 January 2008 and 31 December 2014.

You may not qualify if:

  • Prior subarachnoid haemorrhage.
  • Inhospital symptom onset.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Time

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 2, 2020

First Posted

May 6, 2020

Study Start

May 1, 2020

Primary Completion

February 24, 2021

Study Completion

February 24, 2021

Last Updated

February 25, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations