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| Name | Class |
|---|---|
| South-Eastern Norway Regional Health Authority | OTHER |
| Helse Stavanger HF | OTHER_GOV |
| University of Stavanger | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local thrombectomy | Large 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simulation based quality program | Other | Stroke team simulation. Virtual reality task training simulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Modified Rankin Scale. Minimum value 0 meaning perfect health without symptoms. Maximum value 6 meaning death. | 3 months |
| Morbidity | Modified Rankin Scale. Minimum value 0 meaning perfect health without symptoms. Maximum value 6 meaning death. | 3 months |
| Symptomatic intracranial hemorrhage | Any intracranial hemorrhage with neurologic deterioration leading to an increase in NIHSS score ⬎4 or leading to death | Within 24 hours of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time frames | Time periods based on stroke onset, hospital arrival, thrombectomy start, and end of procedure | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All adults in the hospital catchment area presenting with a large vessel occlusion stroke
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olav Søvik, MD | Contact | +4741689421 | olav.sovik@sshf.no | |
| Per Kristian Hyldmo, MD PhD | Contact | +4741600211 | Per.K.Hyldmo@uis.no |
| Name | Affiliation | Role |
|---|---|---|
| Per Kristian Hyldmo, MD PhD | University of Stavanger, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sørlandet Hospital Health Trust | Recruiting | Kristiansand | Agder | 4604 | Norway |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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) | Up to 5 years |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |