Spontaneous Subarachnoid HemorrhageNCT04377347
Long-term Effects of Time to Treatment in Subarachnoid Haemorrhage
An observational study of Spontaneous Subarachnoid Hemorrhage, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Subarachnoid Hemorrhage
- What is being tested?
- Time
- How many people
- 537 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2020to 24 Feb 2021
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Prior subarachnoid haemorrhage.
- Inhospital symptom onset.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Spontaneous Subarachnoid Hemorrhage
- Being tested
- Time
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TimeOther
Exposure is the time from patients call the Emergency Medical Coordination Center to they are admitted to a neurosurgiocal department.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 May 2020
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 537 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asger Sonne, MD, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377347
- Sponsor's protocol ID
- Outcome
- Status last verified
- Feb 2021
- First submitted
- 2 May 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04377347
- Acronym / sponsor ID
- Outcome
- Conditions
- Spontaneous Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confirmed spontaneous subarachnoid haemorrhage | – | Other: TimePatients, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Prior subarachnoid haemorrhage.
- Inhospital symptom onset.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TimeExposure is the time from patients call the Emergency Medical Coordination Center to they are admitted to a neurosurgiocal department. | Other | Confirmed spontaneous subarachnoid haemorrhage |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Spontaneous Subarachnoid Hemorrhage
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Active, not recruiting
Auricular VNS Following Subarachnoid Hemorrhage
Subarachnoid Hemorrhage
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Parecoxib in Patients With Subarachnoid Hemorrhage
Neurological Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Subarachnoid Hemorrhage, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labour marked affiliation and mortality (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.