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NCT Number: NCT04942041

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simulation based quality program

Other

Stroke team simulation. Virtual reality task training simulation.

Primary outcomes

  1. Mortality

    Time frame: 3 months

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

  2. Morbidity

    Time frame: 3 months

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

  3. Symptomatic intracranial hemorrhage

    Time frame: Within 24 hours of treatment

    Any intracranial hemorrhage with neurologic deterioration leading to an increase in NIHSS score ⬎4 or leading to death

Secondary outcomes

  1. Time frames

    Time frame: Up to 24 hours

    Time periods based on stroke onset, hospital arrival, thrombectomy start, and end of procedure

  2. Technical outcome

    Time frame: Up to 24 hours

    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

  3. Simulation skills

    Time frame: Up to 5 years

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Olav Søvik, MD

CONTACT

[email protected]

+4741689421

Per Kristian Hyldmo, MD PhD

CONTACT

[email protected]

+4741600211

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Collaborators

  • Helse Stavanger HF
  • South-Eastern Norway Regional Health Authority
  • University of Stavanger

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2021
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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