Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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:
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To describe associated time periods based on stroke onset, hospital arrival, thrombectomy start, end of procedure
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To document technical outcomes of mechanical thrombectomies performed at SSK, i.e. degree of reperfusion after thrombectomy
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To document complication rates during mechanical thrombectomies performed at SSK
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To describe the implementation of the quality program at SSK
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To document performance of simulator skill training over time
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| local thrombectomy Large vessel occlusion stroke patients that received thrombectomy at the local center |
Other: Simulation based quality program
Stroke team simulation. Virtual reality task training simulation.
|
| distant thrombectomy Large vessel occlusion stroke patients that received thrombectomy at the distant center |
Outcome Measures
Primary Outcome Measures
- Mortality [3 months]
- Morbidity [3 months]
Modified Rankin Scale. Minimum value 0 meaning perfect health without symptoms. Maximum value 6 meaning death.
- Symptomatic intracranial hemorrhage [Within 24 hours of treatment]
Any intracranial hemorrhage with neurologic deterioration leading to an increase in NIHSS score ⬎4 or leading to death
Secondary Outcome Measures
- Time frames [Up to 24 hours]
Time periods based on stroke onset, hospital arrival, thrombectomy start, and end of procedure
- Technical outcome [Up to 24 hours]
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
- Simulation skills [Up to 5 years]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients
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Large vessel occlusion stroke
Exclusion Criteria:
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Intracranial hemorrhage, tumor, aneurism or vascular malformation i the stroke area
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More than 24 hours after stroke onset
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sørlandet Hospital Health Trust | Kristiansand | Agder | Norway | 4604 |
Sponsors and Collaborators
- Sorlandet Hospital HF
- South-Eastern Norway Regional Health Authority
- Helse Stavanger HF
- University of Stavanger
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 66489 (REK)