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

ConditionStroke, Acute Ischemic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorSorlandet Hospital HF

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients

Large vessel occlusion stroke

Disqualifiers

Intracranial hemorrhage, tumor, aneurism or vascular malformation i the stroke area

More than 24 hours after stroke onset

Trial population

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

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • Simulation based quality program

    Other intervention

    Stroke team simulation. Virtual reality task training simulation.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: local thrombectomy1 intervention
Group B: distant thrombectomy0 interventions

Trial outcomes

Primary outcomes

1

Mortality

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

Time frame
3 months
2

Morbidity

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

Time frame
3 months
3

Symptomatic intracranial hemorrhage

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

Time frame
Within 24 hours of treatment

Secondary outcomes

1

Time frames

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

Time frame
Up to 24 hours
2

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

Time frame
Up to 24 hours
3

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)

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

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Sorlandet Hospital HF

Lead sponsor

South-Eastern Norway Regional Health Authority

Collaborator

Helse Stavanger HF

Collaborator

University of Stavanger

Collaborator

Source ClinicalTrials.gov
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