Stroke, Acute IschemicNCT04942041
Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality
An observational study of Stroke, Acute Ischemic, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
The regional health authorities of South-East Norway has commissioned Sørlandet Hospital (SSHF), Norway to establish mechanical thrombectomy in large-vessel occlusion stroke. SSHF is a limited volume stroke center, and introduction of thrombectomy may impose quality challenges. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Acute Ischemic
- What is being tested?
- Simulation based quality program
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults in the hospital catchment area presenting with a large vessel occlusion stroke
Who may be able to join
- Adult patients
- Large vessel occlusion stroke
Who cannot join
- Intracranial hemorrhage, tumor, aneurism or vascular malformation i the stroke area
- More than 24 hours after stroke onset
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Sørlandet Hospital Health Trust
Kristiansand, Agder, 4604
Olav Søvik, MD, +4741689421, olav.sovik@sshf.no
Per Kristian Hyldmo, MD PhD, +4741600211, Per.K.Hyldmo@uis.no
About this study
Official title: Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality.
The regional health authorities of South-East Norway has commissioned Sørlandet Hospital (SSHF), Norway to establish mechanical thrombectomy in large-vessel occlusion stroke. SSHF is a limited volume stroke center, and introduction of thrombectomy may impose quality challenges. Therefore the implementation will be guided by a simulation based quality assurance program. In this study, we will monitor timelines, technical and clinical outcomes, including adverse events.
Read the detailed description
In acute stroke, two million neurons are lost per minute. Thrombectomy is the treatment of choice for large vessel occlusion stroke: Each minute saved from stroke onset to successful thrombectomy on average extends the healthy life of young patients by a week. Also, more patients may have a thrombectomy option with early treatment, as the time window for thrombectomy is limited.
In 2019, Sørlandet Hospital Kristiansand (SSK) established thrombectomy for stroke. This spared SSK patients from an over 300 km transport to the comprehensive thrombectomy center in Oslo. Avoiding delays due to long transports may lead to lower morbidity and mortality.
However, SSK is a non-university hospital with a limited patient volume, which may contribute to inferior results. To compensate for this, the implementation of thrombectomy at SSK is guided by a national quality program, which includes systematic skill training, simulation team training and continuous local guideline updates.
The primary objective of this observational study is to find out if implementation of thrombectomy at SSK, guided by the quality program, reduces patient morbidity and mortality.
Long transfer times from smaller hospitals to comprehensive thrombectomy centers pose a major problem for the global stroke community. Thus, our results could be generalizable.
Main aim:
- To determine potential changes in patient morbidity and mortality after introduction of thrombectomy at SSK
Secondary aims:
- To describe associated time periods based on stroke onset, hospital arrival, thrombectomy start, end of procedure
- To document technical outcomes of mechanical thrombectomies performed at SSK, i.e. degree of reperfusion after thrombectomy
- To document complication rates during mechanical thrombectomies performed at SSK
- To describe the implementation of the quality program at SSK
- To document performance of simulator skill training over time
- Conditions
- Stroke, Acute Ischemic
- Being tested
- Simulation based quality program
- Keywords
- Stroke, Thrombectomy, Simulation, Quality program
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation based quality programOther
Stroke team simulation. Virtual reality task training simulation.
| Study group | Role | What they receive |
|---|---|---|
| local thrombectomy | Large vessel occlusion stroke patients that received thrombectomy at the local center Receives: Other: Simulation based quality program | |
| distant thrombectomy | Large vessel occlusion stroke patients that received thrombectomy at the distant center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Modified Rankin Scale. Minimum value 0 meaning perfect health without symptoms. Maximum value 6 meaning death.
Measured: 3 months
Morbidity
Modified Rankin Scale. Minimum value 0 meaning perfect health without symptoms. Maximum value 6 meaning death.
Measured: 3 months
Symptomatic intracranial hemorrhage
Any intracranial hemorrhage with neurologic deterioration leading to an increase in NIHSS score ⬎4 or leading to death
Measured: Within 24 hours of treatment
Secondary outcomes (3)
Time frames
Time periods based on stroke onset, hospital arrival, thrombectomy start, and end of procedure
Measured: Up to 24 hours
Technical outcome
Reperfusion graded by modified Thrombolysis in Cerebral Infarction scale. Minimum value 0 meaning no reperfusion. Maximum value 3 meaning complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches
Measured: Up to 24 hours
Simulation skills
Performance of simulator skills before and after a training period. The simulator software records time consumption (seconds), handling errors (number of turns, centimeter movement), fluoroscopy time (seconds), and radiation exposure (Grey per cm2)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Jan 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Acute IschemicStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- South-Eastern Norway Regional Health Authority, Helse Stavanger HF, University of Stavanger
- Responsible party
- Sponsor
- Investigators
- Per Kristian Hyldmo, MD PhD, Principal investigator, University of Stavanger, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942041
- Sponsor's protocol ID
- 66489 (REK)
- Status last verified
- Dec 2023
- First submitted
- 11 Jun 2021
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- 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 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality.
- ClinicalTrials.gov ID
- NCT04942041
- Acronym / sponsor ID
- 66489 (REK)
- Conditions
- Stroke, Acute Ischemic
- Keywords
- Stroke, Thrombectomy, Simulation, Quality program
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- South-Eastern Norway Regional Health Authority, Helse Stavanger HF, University of Stavanger
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jun 2021 (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 regional health authorities of South-East Norway has commissioned Sørlandet Hospital (SSHF), Norway to establish mechanical thrombectomy in large-vessel occlusion stroke. SSHF is a limited volume stroke center, and introduction of thrombectomy may impose quality challenges. Therefore the implementation will be guided by a simulation based quality assurance program. In this study, we will monitor timelines, technical and clinical outcomes, including adverse events.
Detailed description
In acute stroke, two million neurons are lost per minute. Thrombectomy is the treatment of choice for large vessel occlusion stroke: Each minute saved from stroke onset to successful thrombectomy on average extends the healthy life of young patients by a week. Also, more patients may have a thrombectomy option with early treatment, as the time window for thrombectomy is limited.
In 2019, Sørlandet Hospital Kristiansand (SSK) established thrombectomy for stroke. This spared SSK patients from an over 300 km transport to the comprehensive thrombectomy center in Oslo. Avoiding delays due to long transports may lead to lower morbidity and mortality.
However, SSK is a non-university hospital with a limited patient volume, which may contribute to inferior results. To compensate for this, the implementation of thrombectomy at SSK is guided by a national quality program, which includes systematic skill training, simulation team training and continuous local guideline updates.
The primary objective of this observational study is to find out if implementation of thrombectomy at SSK, guided by the quality program, reduces patient morbidity and mortality.
Long transfer times from smaller hospitals to comprehensive thrombectomy centers pose a major problem for the global stroke community. Thus, our results could be generalizable.
Main aim:
- To determine potential changes in patient morbidity and mortality after introduction of thrombectomy at SSK
Secondary aims:
- To describe associated time periods based on stroke onset, hospital arrival, thrombectomy start, end of procedure
- To document technical outcomes of mechanical thrombectomies performed at SSK, i.e. degree of reperfusion after thrombectomy
- To document complication rates during mechanical thrombectomies performed at SSK
- To describe the implementation of the quality program at SSK
- To document performance of simulator skill training over time
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local thrombectomy | – | Other: Simulation based quality programLarge vessel occlusion stroke patients that received thrombectomy at the local center |
| distant thrombectomy | – | –Large vessel occlusion stroke patients that received thrombectomy at the distant center |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults in the hospital catchment area presenting with a large vessel occlusion stroke
Key inclusion criteria (2 listed)
- Adult patients
- Large vessel occlusion stroke
Key exclusion criteria (2 listed)
- Intracranial hemorrhage, tumor, aneurism or vascular malformation i the stroke area
- More than 24 hours after 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation based quality programStroke team simulation. Virtual reality task training simulation. | Other | local thrombectomy |
Primary outcome
Mortality
Time frame: 3 months
Modified Rankin Scale. Minimum value 0 meaning perfect health without symptoms. Maximum value 6 meaning death.
Morbidity
Time frame: 3 months
Modified Rankin Scale. Minimum value 0 meaning perfect health without symptoms. Maximum value 6 meaning death.
Symptomatic intracranial hemorrhage
Time frame: Within 24 hours of treatment
Any intracranial hemorrhage with neurologic deterioration leading to an increase in NIHSS score ⬎4 or leading to death
3 secondary outcomes
Time frames
Time frame: Up to 24 hours
Technical outcome
Time frame: Up to 24 hours
Simulation skills
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Per Kristian Hyldmo, MD PhD principal investigator
University of Stavanger, Norway
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 Ischemic, run by Sorlandet Hospital 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 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: looking for participants now, as of the sponsor's last update on 29 Dec 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olav Søvik, MD (+4741689421, olav.sovik@sshf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 3 months). The study lists 3 primary outcomes in all. 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 29 Dec 2023.