Long-term Effects of Time to Treatment in Subarachnoid Haemorrhage

February 24, 2021 updated by: Asger Sonne, MD, Rigshospitalet, Denmark

Time From First Health Care Contact to Neurosurgical Admission and the Effect on Long-term Labour Market Affiliation and Mortality in Patients With Spontaneous Subarachnoid Haemorrhage

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

537

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Prior subarachnoid haemorrhage.
  • Inhospital symptom onset.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Exposure is the time from patients call the Emergency Medical Coordination Center to they are admitted to a neurosurgiocal department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Labour marked affiliation and mortality
Time Frame: 4 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

February 24, 2021

Study Completion (Actual)

February 24, 2021

Study Registration Dates

First Submitted

May 2, 2020

First Submitted That Met QC Criteria

May 2, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Outcome

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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