Stroke, AcuteNCT04373993
Prehospital Minutes Count During a Stroke.
An observational study of Stroke, Acute, run by Nordlandssykehuset HF at 1 site in Norway.
Trial summary
The ultimate objective is to improve the efficacy of prehospital procedures for patients suffering an acute stroke. Increased precision in prehospital selection and a more efficient transport chain will lead to an even more rapid start of treatment and thus benefit patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- How many people
- 1,100 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2018to 30 Jun 2025
- 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: All patients discharged from the respective hospitals with a diagnosis of stroke during the period of inclusion.
Who may be able to join
- Final diagnosis of stroke at discharge from hospital
Who cannot join
- Hospital admission later than one week from stroke onset
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prehospital Minutes Count During a Stroke. Factors Associated With Prehospital Delays With Data From Various Regions in Norway and One Region in Switzerland
The ultimate objective is to improve the efficacy of prehospital procedures for patients suffering an acute stroke. Increased precision in prehospital selection and a more efficient transport chain will lead to an even more rapid start of treatment and thus benefit patients. The research project has two parts: one part collecting data from medical reports and one study with qualitative in-depth interviews. The project will gather data from various parts of Norway and from a University hospital in Switzerland for comparison between regions and countries. Data will be retrieved through intrahospital and prehospital medical records from various parts of Norway (Nordland Hospital, Akershus University Hospital and Helgeland Hospital) and from Basel University hospital in Switzerland. Knowledge of factors associated with delays will be compared for regions in the north and south of Norway, as well as abroad. The information obtained will be analysed to identify components in the chain that may be improved as concerns time saving.
- Conditions
- Stroke, Acute
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nordlandssykehuset HF | Not described | |
| Akershus universitetsssykehus | Not described | |
| Helgelandssykehuset | Not described | |
| Basel University Hospital | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time delay from ictus to hospital arrival
Delay from first symptoms of stroke until arrival at hospital
Measured: Within 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Jun 2018
- Primary completion1 Dec 2023
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373993
- Sponsor's protocol ID
- 2016/1729 REK
- Status last verified
- Mar 2024
- First submitted
- 30 Apr 2020
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Minutes Count During a Stroke. Factors Associated With Prehospital Delays With Data From Various Regions in Norway and One Region in Switzerland
- ClinicalTrials.gov ID
- NCT04373993
- Acronym / sponsor ID
- 2016/1729 REK
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Collaborators
- University Hospital, Akershus
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 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.
The ultimate objective is to improve the efficacy of prehospital procedures for patients suffering an acute stroke. Increased precision in prehospital selection and a more efficient transport chain will lead to an even more rapid start of treatment and thus benefit patients. The research project has two parts: one part collecting data from medical reports and one study with qualitative in-depth interviews. The project will gather data from various parts of Norway and from a University hospital in Switzerland for comparison between regions and countries. Data will be retrieved through intrahospital and prehospital medical records from various parts of Norway (Nordland Hospital, Akershus University Hospital and Helgeland Hospital) and from Basel University hospital in Switzerland. Knowledge of factors associated with delays will be compared for regions in the north and south of Norway, as well as abroad. The information obtained will be analysed to identify components in the chain that may be improved as concerns time saving.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nordlandssykehuset HF | – | – |
| Akershus universitetsssykehus | – | – |
| Helgelandssykehuset | – | – |
| Basel University Hospital | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients discharged from the respective hospitals with a diagnosis of stroke during the period of inclusion.
Key inclusion criteria (1 listed)
- Final diagnosis of stroke at discharge from hospital
Key exclusion criteria (1 listed)
- Hospital admission later than one week from stroke onset
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time delay from ictus to hospital arrival
Time frame: Within 4 hours
Delay from first symptoms of stroke until arrival at hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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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 Stroke, Acute, run by Nordlandssykehuset HF at 1 site in Norway.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 May 2024. 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 Norway. 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?
Results are not available in the source record.
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?
Time delay from ictus to hospital arrival (time frame: Within 4 hours). 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 13 May 2024.