Clinical trial NCT03577847: Rural CT Examination and Thrombolytic Treatment for Stroke
Official title: Rural CT Examination and Thrombolytic Treatment for Stroke: An Observational Study of Medical and Health Economic Effects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Stroke, Thrombolysis, Rural CT
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: Extrastiftelsen
First posted: 2018-07-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intervention group (access to local CT):

Patients from the municipalities Hol, Ål, Gol, Hemsedal and Nes.

Control group (no local CT):

Patients from the municipalities Nore and Uvdal, Vang, Øystre- and Vestre Slidre, Lesja, Skjåk, Lom, Dovre, Vågå and Sel.

Brief summary: To counteract long term sequelae from stroke, ultrarapid diagnosis and treatment, high quality multidiciplinary in-hospital care and optimal long term rehabilitation is required. In this study, the investigators are moving the essential first diagnosis and treatment out into the community close to where the patient live, thus shortening the all important time from debut of symptoms to thrombolytic treatment improving the prognosis of stroke patients.

Detailed description: Stroke is an acute, potentially mutilating disease. To counteract long term sequelae three factors are essential: Ultrarapid diagnosis and treatment, high quality multidiciplinary in-hospital care and optimal long term rehabilitation. Initial diagnosis and treatment has up to now been completed within the hospital domain. This study will change that: moving the essential first diagnosis and treatment out into the community close to where the patient lives thus shortening the all important time from debut of symptoms to thrombolytic treatment. We will operate a local computer tomography (CT) service in the hands of community based non-specialized health care personnel (MD and nurse) acting under direct telemetric guidance from on call hospital specialists. Thus, the investigators will show that by combining current technological advances in real time video communication with an acutely well functioning cooperation between the community and hospital health service personnel the prognosis of stroke patients is improved.

Eligibility criteria: Inclusion Criteria:

1. Patients over 18 years being investigated by CT within 24 hours for acute symptoms of stroke.
2. Fullfilling criteria for the diagnosis acute stroke as described by the Norwegian stroke registry.
3. Giving informed consent.

Exclusion Criteria:

1. Symptoms not due to ischaemic or haemorrhagic stroke as adjudicated at discharge.
2. Not able to cooperate to 3 months follow up.
3. Not giving informed consent

Primary outcomes:
measure: Thrombolytic treatment
timeFrame: 3 months
Secondary outcomes:
measure: Ictus to needle time
timeFrame: 3 months
measure: Functional status
timeFrame: 3 months
measure: Cognitive status
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
Other outcomes:
Locations:
city: Honefoss
country: Norway
facility: Vestre Viken Hospital Trust
state: Buskerud
Study officials:
affiliation: Vestre Viken Hospital Trust
name: Jorgen M Ibsen, MD
role: PRINCIPAL_INVESTIGATOR
References: