Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Simulation based quality program.
- Who it may be relevant to
- Registry conditions: Stroke, Acute Ischemic. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality.
Overview
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
Interventions
- Other Simulation based quality program
Stroke team simulation. Virtual reality task training simulation.
Primary outcome measures
- Mortality [Time frame: 3 months]
- Morbidity [Time frame: 3 months]
- Symptomatic intracranial hemorrhage [Time frame: Within 24 hours of treatment]
Secondary outcome measures (3)
- Time frames [Time frame: Up to 24 hours]
- Technical outcome [Time frame: Up to 24 hours]
- Simulation skills [Time frame: Up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Norway · 1 center
- Sørlandet Hospital Health Trust — Kristiansand
Identifiers
NCT: NCT04942041 · 66489 (REK)