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

NCT ID: NCT04942041

Last Updated: 2023-12-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2026-12-31

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

Conditions

Stroke, Acute Ischemic

Keywords

Stroke; Thrombectomy; Simulation; Quality program

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

local thrombectomy

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

Simulation based quality program

Intervention Type: OTHER

Stroke team simulation. Virtual reality task training simulation.

distant thrombectomy

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

No interventions assigned to this group

Interventions

Simulation based quality program

Stroke team simulation. Virtual reality task training simulation.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

University of Stavanger

OTHER

Sponsor Role: collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Kristian Hyldmo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Stavanger, Norway

Locations

Sørlandet Hospital Health Trust

Kristiansand, Agder, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Olav Søvik, MD

Role: CONTACT

Phone: +4741689421

Email: olav.sovik@sshf.no

Per Kristian Hyldmo, MD PhD

Role: CONTACT

Phone: +4741600211

Email: Per.K.Hyldmo@uis.no

Facility Contacts

Olav Søvik, MD

Role: primary

Per Kristian Hyldmo, MD PhD

Role: backup

Other Identifiers

66489 (REK)

Identifier Type: -

Identifier Source: org_study_id