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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute Ischemic
• Intervention / Treatment: Other: Simulation based quality program

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

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Olav Søvik, MD; Phone Number: +4741689421; Email: olav.sovik@sshf.no
• Study Contact Backup: Name: Per Kristian Hyldmo, MD PhD; Phone Number: +4741600211; Email: Per.K.Hyldmo@uis.no

Study Locations

• Norway
  • Agder
    • Kristiansand, Agder, Norway, 4604
      • Recruiting
      • Sørlandet Hospital Health Trust
      • Contact: Olav Søvik, MD; Phone Number: +4741689421; Email: olav.sovik@sshf.no
      • Contact: Per Kristian Hyldmo, MD PhD; Phone Number: +4741600211; Email: Per.K.Hyldmo@uis.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All adults in the hospital catchment area presenting with a large vessel occlusion stroke

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
local thrombectomy; Large vessel occlusion stroke patients that received thrombectomy at the local center	Other: Simulation based quality program; Stroke team simulation. Virtual reality task training simulation.
distant thrombectomy; Large vessel occlusion stroke patients that received thrombectomy at the distant center

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mortality	Modified Rankin Scale. Minimum value 0 meaning perfect health without symptoms. Maximum value 6 meaning death.	3 months

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

Collaborators and Investigators

• Sponsor: Sorlandet Hospital HF
• Collaborators: Helse Stavanger HF; South-Eastern Norway Regional Health Authority; University of Stavanger
• Investigators: Principal Investigator: Per Kristian Hyldmo, MD PhD, University of Stavanger, Norway

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Thrombectomy; Simulation; Quality program
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 66489 (REK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No