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Trial record 1 of 4 for:    26898852 [PUBMED-IDS]
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TReatment Strategy In Acute Ischemic larGE Vessel STROKE: Prioritize Thrombolysis or Endovascular Treatment (TRIAGE)

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ClinicalTrials.gov Identifier: NCT03542188
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : May 2, 2019
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Should we prioritize thrombectomy or thrombolysis in acute stroke? Finding the answer to this question will improve treatment and outcome for stroke patients only by changing triage and transportation. And it will have implications for stroke patients around the world.

The investigators propose a national investigator-driven, multi-center, randomised single-blinded clinical trial to investigate which treatment strategy is superior in patients with acute stroke and suspected large vessel occlusion (LVO): direct transport to a comprehensive stroke center for early endovascular therapy (EVT) or to a primary stroke center for early IV thrombolysis followed by secondary transport to a comprehensive stroke center for EVT if needed.

Effective reperfusion therapy marks a new era within stroke medicine and has been driving major changes in the organization of care within the last decade. Timely thrombolysis and/or EVT in acute ischemic stroke is a key factor for improved outcome. Major stroke occur in 25% of all cases and is caused by LVO. Major strokes have approximately 60% risk of severe disability or death at three months if not treated. EVT is superior to thrombolysis in strokes caused by a LVO, but EVT is only performed in specialized centers due to the complexity of the treatment and need for skilled neurointerventionalists.

A simple stroke severity score has been developed, that can identify most patients with LVO in the pre-hospital setting. This enables selection of patients with a suspected LVO to be transported without delay directly to a comprehensive stroke center for EVT while potentially bypassing a nearer primary stroke center for IV-thrombolysis.

Study results will have major impact of future acute stroke treatment and organization.


Condition or disease Intervention/treatment Phase
Stroke Behavioral: Primary Stroke Center (PSC) Behavioral: Comprehensive Stroke Center (CSC) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Single-blinded
Primary Purpose: Treatment
Official Title: TReatment Strategy In Acute Ischemic larGE Vessel STROKE: Prioritize Thrombolysis or Endovascular Treatment
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Arm Intervention/treatment
Active Comparator: Primary Stroke Center (PSC)
Transport to a primary stroke center for early IV-thrombolysis followed by a secondary transport to a comprehensive stroke center for EVT if needed.
Behavioral: Primary Stroke Center (PSC)
Transport to a primary stroke center for early IV-thrombolysis followed by a secondary transport to a comprehensive stroke center for EVT if needed.

Behavioral: Comprehensive Stroke Center (CSC)
Direct transport to a comprehensive stroke center for IV-thrombolysis and early EVT.

Experimental: Comprehensive Stroke Center (CSC)
Direct transport to a comprehensive stroke center for IV-trombolysis and early EVT.
Behavioral: Comprehensive Stroke Center (CSC)
Direct transport to a comprehensive stroke center for IV-thrombolysis and early EVT.




Primary Outcome Measures :
  1. mRS score after 90 days for AIS patients [ Time Frame: 90 days ]
    Blinded outcome of functional disability at 90 days using modified Rankin Score (mRS) ranging from no symptoms (score 0) to dead (score 6) analyzed as shift analysis in all patients ending with diagnosis of AIS.


Secondary Outcome Measures :
  1. mRS score after 90 days (shift analysis) for all randomized. [ Time Frame: 90 days ]
    Blinded outcome of functional disability at 90 days using modified Rankin Score (mRS) ranging from no symptoms (score 0) to dead (score 6) analyzed as shift analysis in all randomized patients

  2. mRS score after 90 days (shift analysis) for AIS patients without LVO [ Time Frame: 90 days ]
    Blinded outcome of functional disability at 90 days using modified Rankin Score (mRS) ranging from no symptoms (score 0) to dead (score 6) analyzed as shift analysis in all patiens without LVO

  3. mRS score after 90 days (shift analysis) for patients with hemorrhagic stroke [ Time Frame: 90 days ]
    Blinded outcome of functional disability at 90 days using modified Rankin Score (mRS) ranging from no symptoms (score 0) to dead (score 6) analyzed as shift analysis in all with hemorrhagic stroke

  4. mRS score after 90 days (shift analysis) for patients with stroke mimics [ Time Frame: 90 days ]
    Blinded outcome of functional disability at 90 days using modified Rankin Score (mRS) ranging from no symptoms (score 0) to dead (score 6) analyzed as shift analysis in all patients with stroke mimics

  5. mRS score ≤2 (independent) after 90 days for AIS patients treated with EVT [ Time Frame: 90 days ]
    Blinded outcome of functional disability at 90 days using modified Rankin Score (mRS) ranging from no symptoms (score 0) to dead (score 6) analyzed as shift analysis in all patients treated with EVT

  6. Severe dependency or death after 90 days for AIS patients treated with EVT [ Time Frame: 90 days ]
    mRS score 5+6 (severe dependency or death) after 90 days for AIS patients treated with EVT. (Safety endpoint.)

  7. Severe dependency or death after 90 days in patients with hemorrhagic stroke [ Time Frame: 90 days ]
    mRS score 5+6 (severe dependency or death) after 90 days in patients with hemorrhagic stroke. (Safety endpoint.)

  8. Times (from onset, pick-up and arrival) to groin puncture for patients treated with EVT [ Time Frame: 1 day ]
    Mean time to groin puncture for patients treated with EVT

  9. Times (from onset, pick-up and arrival)to IV thrombolysis for patients treated with IV thrombolysis only. [ Time Frame: 1 day ]
    Mean time to IV thrombolysis for patients treated with IV thrombolysis only. (Safety endpoint.)

  10. Successful re-perfusion in EVT treated [ Time Frame: 1 day ]
    modified Trombolysis In Cerebral Iscemia (TICI) 2b-3

  11. Length of stay at CSC for all patients withpot LVO [ Time Frame: 1 week ]
    Median time in hours at CSC



Information from the National Library of Medicine

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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:

  1. Symptoms of acute stroke
  2. No contraindication for IV thrombolysis
  3. Stroke occurring ("pick up" place) in catchment area of a primary stroke center
  4. The patient has Pre-hospital Acute Stroke Severity (PASS) score ≥2
  5. Pre-stroke modified Rankin Score 0-2 (meaning living independently.)
  6. Feasible to start IV-thrombolysis within 4.5 hours at CSC

Exclusion Criteria:

  1. Syncope
  2. Seizure
  3. Known diagnosis of epilepsy
  4. Medical condition and no signs of stroke (e.g. hypoglycemia)
  5. In-hospital strokes
  6. Life expectancy of less than 1 year.

Exclusion criteria for the analysis of the ischemic patients (to be determined after admission at stroke center)

  1. Imaging showing ICH
  2. Stroke mimics

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): NCT03542188


Contacts
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Contact: Anne B Behrndtz, MD 004520784242 abbehrndtz@gmail.com
Contact: Claus Z Simonsen, MD, PhD 004550240543 claus_ziegler@hotmail.com

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
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Principal Investigator: Claus Z Simonsen, MD, PhD Aarhus University Hospital
Study Director: Grethe Andersen, Professor Aarhus University Hospital

Additional Information:
Publications:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03542188     History of Changes
Other Study ID Numbers: CT1-10-72-28-18
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Large Vessel Occlusion
Stroke
EVT
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases