Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality.

Conditions
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Stroke, Acute Ischemic

Intervention / Treatment
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* Other: Simulation based quality program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients Large vessel occlusion stroke Exclusion Criteria: Intracranial hemorrhage, tumor, aneurism or vascular malformation i the stroke area More than 24 hours after stroke onset

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| local thrombectomy<br>Large vessel occlusion stroke patients that received thrombectomy at the local center | Other: Simulation based quality program<br>* Stroke team simulation. Virtual reality task training simulation.<br>|
| distant thrombectomy<br>Large vessel occlusion stroke patients that received thrombectomy at the distant center | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Thrombectomy, Simulation, Quality program