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TReatment Strategy In Acute Ischemic larGE Vessel STROKE: Prioritize Thrombolysis or Endovascular Treatment

NCT03542188 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2022-12-14

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Claus Z Simonsen, MD, PhD · Aarhus University Hospital

  • Grethe Andersen, Professor · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03542188 on ClinicalTrials.gov