Clinical trial NCT04942041: Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality
Official title: Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute Ischemic
Keywords: Stroke
Thrombectomy
Simulation
Quality program
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: South-Eastern Norway Regional Health Authority
name: Helse Stavanger HF
name: University of Stavanger
First posted: 2021-06-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All adults in the hospital catchment area presenting with a large vessel occlusion stroke

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.

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

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

Primary outcomes:
measure: Mortality
timeFrame: 3 months
measure: Morbidity
timeFrame: 3 months
measure: Symptomatic intracranial hemorrhage
timeFrame: Within 24 hours of treatment
Secondary outcomes:
measure: Time frames
timeFrame: Up to 24 hours
measure: Technical outcome
timeFrame: Up to 24 hours
measure: Simulation skills
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sørlandet Hospital Health Trust
state: Agder
Study officials:
affiliation: University of Stavanger, Norway
name: Per Kristian Hyldmo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: