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

Sorlandet Hospital HF

Status: Enrolling

Conditions: Stroke, Acute Ischemic

Treatments: Other: Simulation based quality program

Study type: Observational

Funder types: Other

Identifiers

NCT04942041

66489 (REK)

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

local thrombectomy

Description:

Large vessel occlusion stroke patients that received thrombectomy at the local center

Treatment:

Other: Simulation based quality program

distant thrombectomy

Description:

Large vessel occlusion stroke patients that received thrombectomy at the distant center