Sørlandet Hospital Health Trust
Kristiansand, Agder, 4604, Norway
Location status: Recruiting
Location contact
Olav Søvik, MD
CONTACT
Per Kristian Hyldmo, MD PhD
CONTACT
NCT Number: NCT04942041
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Kristiansand, Agder, 4604, Norway
Location status: Recruiting
Olav Søvik, MD
CONTACT
Per Kristian Hyldmo, MD PhD
CONTACT
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:
Secondary aims:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stroke team simulation. Virtual reality task training simulation.
Time frame: 3 months
Modified Rankin Scale. Minimum value 0 meaning perfect health without symptoms. Maximum value 6 meaning death.
Time frame: 3 months
Modified Rankin Scale. Minimum value 0 meaning perfect health without symptoms. Maximum value 6 meaning death.
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
Time frame: Up to 24 hours
Time periods based on stroke onset, hospital arrival, thrombectomy start, and end of procedure
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
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)
Contact information is provided by the study sponsor or research team.
Olav Søvik, MD
CONTACT
Per Kristian Hyldmo, MD PhD
CONTACT
Sorlandet Hospital HF
Other Gov
Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality.
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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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