The Norwegian Acute Stroke Prehospital Project (NASPP)
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|ClinicalTrials.gov Identifier: NCT03036020|
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
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The main aim of the NASPP study is to assess the efficacy and safety of the prehospital diagnosis of stroke using the Norwegian stroke ambulance concept. NASPP aims to demonstrate that anesthesiologists trained in pre-hospital critical care may perform acute stroke diagnostics by clinical assessment and CT scan interpretation and integrating these skills in the already existing organizational frame of the Norwegian prehospital EMS system.
NASPP will systematically explore the Norwegian model of prehospital acute stroke diagnostics prior to the implementation of prehospital thrombolytic stroke treatment. NASSP will equip a regular ambulance staffed with a specially trained anesthesiologist and a specialized nurse. NASPP will perform the clinical part of the study in close co-operation with Østfold Hospital, Fredrikstad.
|Condition or disease||Intervention/treatment||Phase|
|Acute Stroke Traumatic Brain Injury||Radiation: CereTom Neurologica Samsung||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Norwegian Acute Stroke Prehospital Project|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Contraindication anesthesiologists
Ability of anesthesiologists to detect contraindications to thrombolysis in acute stroke patients prehospital by interpretation of prehospital cerebral CT scans
Radiation: CereTom Neurologica Samsung
Diagnosis of acute stroke patients by cerebral CT diagnostics prehospital
- Inter-rated agreement between the anesthesiologist and the inhospital stroke team (radiologist and neurologist) [ Time Frame: Baseline ]The ambulance anesthesiologist assesses the pre-hospital cerebral CT scan and fills out the predefined variables in designated study forms. All cerebral CT interpreations are categorized in 1) no radiological contraindication to thrombolytics 2) yes radiological contraindication to thrombolytics. The CT scan is simultaneously sent to the hospital, for interpretation by the neurologist and the radiologist on call. The anesthesiologist intgerpration is blinded to the stroke team. A neuroradiologist will, without any clinical knowledge, review the CT scans after the study has included is completed. The results from the initial interpretation by the ambulance anesthesiologist are held anonymous, and blinded for the neuroradiologist. The results will be analyzed statistically to show distribution of the different categories of inter-rater agreement, compared to the neurologists and radiologists at the admission hospital.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- All patients met by emergency services within 4 hours after symptom onset
- Stroke symptoms: sudden weakness of leg or arm, especially on one side, facial asymmetry and/or sudden trouble walking, and speech disturbance (Norwegian Index of medical emergencies 27.03-27.05).
- Patients from the Hospital dispatch center area, being more than 10-15 minutes drive from the hospital.
- Giving informed consent, written or oral, if possible or consent from relative at site
- Age under 18 years
- Female < 50 years and uncertainty of pregnancy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036020
|Østfold Hospital Norway|
|Principal Investigator:||Christian G Lund, MD Phd||Oslo University Hospital|
|Responsible Party:||Kristi G. Bache, PhD, Head of Research Department at The Norwegian Air Ambulance Foundation, Norwegian Air Ambulance Foundation|
|Other Study ID Numbers:||
|First Posted:||January 30, 2017 Key Record Dates|
|Last Update Posted:||January 30, 2017|
|Last Verified:||January 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Brain Injuries, Traumatic
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries