Stroke Clinical Trial
— TRIAGEOfficial title:
TReatment Strategy In Acute Ischemic larGE Vessel STROKE: Prioritize Thrombolysis or Endovascular Treatment
Verified date | December 2022 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 174 |
Est. completion date | August 31, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital |
Denmark,
Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18. — View Citation
Hastrup S, Damgaard D, Johnsen SP, Andersen G. Prehospital Acute Stroke Severity Scale to Predict Large Artery Occlusion: Design and Comparison With Other Scales. Stroke. 2016 Jul;47(7):1772-6. doi: 10.1161/STROKEAHA.115.012482. Epub 2016 Jun 7. — View Citation
Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17. — View Citation
Southerland AM, Johnston KC, Molina CA, Selim MH, Kamal N, Goyal M. Suspected Large Vessel Occlusion: Should Emergency Medical Services Transport to the Nearest Primary Stroke Center or Bypass to a Comprehensive Stroke Center With Endovascular Capabilities? Stroke. 2016 Jul;47(7):1965-7. doi: 10.1161/STROKEAHA.115.011149. Epub 2016 Feb 19. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | TimesEVT | (from onset, pick-up and arrival) to groin puncture for patients treated with EVT (Mean time to groin puncture for patients treated with EVT) | up to 24 hours | |
Other | TimesIVT | (from onset, pick-up and arrival) to IV thrombolysis for patients treated with IV thrombolysis only. Time to IV thrombolysis for patients treated with IV thrombolysis only (bypass vs. direct transport.) (Safety endpoint.) | up to 24 hours | |
Other | Successful reperfusion | modified Thrombolysis In Cerebral Ischemia 2b-3) in EVT treated (bypass vs. direct transport | up to 24 hours | |
Other | Length of stay at CSC | Length of stay at CSC for all patients without LVO | up to 30 days | |
Other | QUALY | Quality of life qual-5 | up to 4 months | |
Primary | mRS score after 90 days for AIS patients | 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. | 90 days | |
Secondary | mRS score after 90 days (shift analysis) for all randomized. | 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 | 90 days | |
Secondary | mRS score after 90 days (shift analysis) for AIS patients without LVO | 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 | 90 days | |
Secondary | mRS score after 90 days (shift analysis) for patients with hemorrhagic stroke | 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 | 90 days | |
Secondary | mRS score after 90 days (shift analysis) for patients with stroke mimics | 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 | 90 days | |
Secondary | mRS score =2 (independent) after 90 days for AIS patients treated with EVT | 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 | 90 days | |
Secondary | Severe dependency or death after 90 days for AIS patients treated with EVT | mRS score 5+6 (severe dependency or death) after 90 days for AIS patients treated with EVT. (Safety endpoint.) | 90 days | |
Secondary | Severe dependency or death after 90 days in patients with hemorrhagic stroke | mRS score 5+6 (severe dependency or death) after 90 days in patients with hemorrhagic stroke. (Safety endpoint.) | 90 days | |
Secondary | Times (from onset, pick-up and arrival) to groin puncture for patients treated with EVT | Mean time to groin puncture for patients treated with EVT | 1 day | |
Secondary | Times (from onset, pick-up and arrival)to IV thrombolysis for patients treated with IV thrombolysis only. | Mean time to IV thrombolysis for patients treated with IV thrombolysis only. (Safety endpoint.) | 1 day | |
Secondary | Successful re-perfusion in EVT treated | modified Trombolysis In Cerebral Iscemia (TICI) 2b-3 | 1 day | |
Secondary | Length of stay at CSC for all patients withpot LVO | Median time in hours at CSC | 1 week |
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