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

NCT04942041 | Recruiting

• 1 other identifier: 66489 (REK)
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute Ischemic

Keywords

Stroke; Thrombectomy; Simulation; Quality program

Outcome Measures

Primary Outcomes (3)

• Mortality

  Modified Rankin Scale. Minimum value 0 meaning perfect health without symptoms. Maximum value 6 meaning death.

  3 months

• 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

Secondary Outcomes (3)

• Time frames

  Up to 24 hours

• Technical outcome

  Up to 24 hours

• Simulation skills

  Up to 5 years

Study Arms (2)

local thrombectomy

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

Other: Simulation based quality program

distant thrombectomy

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

Interventions

Simulation based quality program OTHER

Stroke team simulation. Virtual reality task training simulation.

local thrombectomy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Adult patients
• Large vessel occlusion stroke

You may not qualify if:

• Intracranial hemorrhage, tumor, aneurism or vascular malformation i the stroke area
• More than 24 hours after stroke onset

Sponsors & Collaborators

• Sorlandet Hospital HF: lead
• South-Eastern Norway Regional Health Authority: collaborator
• Helse Stavanger HF: collaborator
• University of Stavanger: collaborator

Study Sites (1)

Sørlandet Hospital Health Trust

Kristiansand, Agder, 4604, Norway

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Per Kristian Hyldmo, MD PhD

  University of Stavanger, Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olav Søvik, MD

CONTACT

+4741689421; olav.sovik@sshf.no

Per Kristian Hyldmo, MD PhD

CONTACT

+4741600211; Per.K.Hyldmo@uis.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 28, 2021
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)