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Prehospital Advanced Diagnostics and Treatment of Acute Stroke (Treat-NASPP)

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ClinicalTrials.gov Identifier: NCT03158259
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : May 18, 2017
Sponsor:
Collaborators:
Ostfold Hospital Trust
University of Oslo
Oslo University Hospital
Information provided by (Responsible Party):
Norwegian Air Ambulance Foundation

Brief Summary:

The objective of this study is to investigate the effectiveness of prehospital diagnosis and, when appropriate, of intravenous thrombolytic treatment of ischemic stroke. At the same time, we will take the opportunity to do an explorative study with the aim to further improve the intervention by biomarkers, and outcome measures volumetric measured by MRI images.

The intervention study aim to:

  • Determine the time from symptom onset to thrombolytic treatment in the Mobila Stroke Unit (MSU) compared to the conventional model
  • Determine the number of patients receiving thrombolytic treatment within the 4.5 hrs window in the MSU compared to the conventional model
  • Determine if thrombolytic treatment in the MSU, when adjusted for time, results in better mRS- and Barthel outcome compared to treatment in the conventional model The explorative study aim to
  • Determine if final IS infarction volume estimated by MRI, is independently correlated with time from symptom onset to thrombolytic treatment
  • Define cut-off values for GFAP and RBP4 combined that with sufficient specificity and sensitivity can distinguish ICH from IS
  • Determine the influence of time to treatment on pro-inflammatory markers after stroke

Hypothesis Intervention study I. The Treat - NASPP MSU model is feasible and reduces onset to treatment time less than 15 min II. The number of patient treated with thrombolysis within 4.5 hrs of symptom onset is significantly increased in the Treat-NASPP MSU model III. Treatment in the Treat-NASPP MSU model does not result in increased day 90 mRS and Barthel as compared to the conventional model when adjusted for time IV. Prehospital thrombolytic treatment of stroke does not increase the risk of secondary cerebral bleeding as compared to in-hospital thrombolytic treatment of stroke (cerebral bleeding worsening within 36 hrs less than 4 per cent, Norsk hjerneslagregister) Explorative study V. The final infarct volume, estimated by MRI, is significantly reduced when thrombolytic treatment is initiated already in the MSU VI. Biomarkers is a valid tool in the hyper acute phase of cerebral illness to exclude contraindication to thrombolysis VII. Reduced onset to treatment time results in lower levels of selected pro-inflammatory molecules


Condition or disease Intervention/treatment Phase
Ischemic (Brain) Stroke Hemorrhagic Stroke TIA, Brain Other: Prehospital diagnosis and treatment Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective controlled intervention study
Masking: None (Open Label)
Masking Description: Clinical tests and recordings will not be performed by investigator invested in the study.
Primary Purpose: Diagnostic
Official Title: Advanced Diagnostics of Acute Stroke (Biomarkers, Blood Analysis, Stroke Scales and Cerebral CT Examinations) and Initiation of rtPa Treatment in an Air Ambulance Model
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2021

Arm Intervention/treatment
Experimental: Intervention group MSU
Patient will be diagnosed (NIHSS, CT and conventional blood-measures) and given thrombolytic treatment (when indicated) prehospitally by anesthesiologist in Mobile Stroke Unit (MSU)
Other: Prehospital diagnosis and treatment
The patient will be diagnosed and treated by anesthesiologist in the mobile stroke unit (MSU). The diagnosis will be NIHSS, CT scans by a CT-scanner fitted in the MSU, and blood-analysis in a mobile lab inside the MSU. All performed by a three-person crew consisting of an anesthesiologist, paramedic and nurse-paramedic. The CT images will be sent to the lokal hospital and contact with neurologist in ward established. A decision to treat will be given in collaboration between the neurologist and anesthesiologist.

Active Comparator: Conventional ambulance
Patient will be brought to hospital by normal ambulance according to existing procedures. Diagnosis (NIHSS, CT and conventional blood-measures) and thrombolytic treatment (when indicated) will be given in hospital.
Other: Prehospital diagnosis and treatment
The patient will be diagnosed and treated by anesthesiologist in the mobile stroke unit (MSU). The diagnosis will be NIHSS, CT scans by a CT-scanner fitted in the MSU, and blood-analysis in a mobile lab inside the MSU. All performed by a three-person crew consisting of an anesthesiologist, paramedic and nurse-paramedic. The CT images will be sent to the lokal hospital and contact with neurologist in ward established. A decision to treat will be given in collaboration between the neurologist and anesthesiologist.




Primary Outcome Measures :
  1. Onset to treatment (OTT) [ Time Frame: 0 - 4.5 hours ]
    Time from ictus (stroke/symptomes of stroke) to patient receive appropriate care (thrombolysis when indicated)

  2. Number of patients treated within 4.5 hours [ Time Frame: 0 - 4.5 hours ]
    The number of patients treated within 4.5 hours


Secondary Outcome Measures :
  1. mRS and Barthel at day 90 adjusted for OTT time [ Time Frame: 90 days after symptom-debut ]
    The state of the patient after 90 days as measured by clinical scoring measures called modified ranking scale and Barthel

  2. Concentration of designated proteins in Ischemic Stroke-patients and patients with Intra Cranial Hemorrhage [ Time Frame: When patient first meets anesthesiologist or paramedic (1 day) ]
    Plasma from blood collected from patients at the hyper acute phase (first met by health care provider) will be analyzed for various protein concentrations

  3. Infarction volume as measured by MRI [ Time Frame: day 1-3 ]
    The size of the infarction site will be measured based on MR-images taken at day 1-3



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with suspected stroke 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 27.03-27.06).

Exclusion Criteria:

  • Age under 18 years Pregnancy Female < 50 years and uncertainty of pregnancy Uncertainty regarding symptom onset time

Information from the National Library of Medicine

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): NCT03158259


Contacts
Contact: Kristi G Bache, PhD 46542271 ext +47 kristi.bache@norskluftambulanse.no
Contact: Christian G Lund, MD PhD 92019415 ext +47 lundchr@online.no

Locations
Norway
Department of Research and Development, Norwegian Air Ambulance Foundation Recruiting
Drøbak, Norway, 1441
Contact: Kristi A Bache, PhD    46542271 ext +47    kristi.bache@norskluftambulanse.no   
Sponsors and Collaborators
Norwegian Air Ambulance Foundation
Ostfold Hospital Trust
University of Oslo
Oslo University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norwegian Air Ambulance Foundation
ClinicalTrials.gov Identifier: NCT03158259     History of Changes
Other Study ID Numbers: 726120
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian Air Ambulance Foundation:
IS
ICH
rtPa
Prehospital
MSU

Additional relevant MeSH terms:
Stroke
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia