Direct Transfer to an Endovascular Center Compared to Transfer to the Closest Stroke Center in Acute Stroke Patients With Suspected Large Vessel Occlusion (RACECAT)
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|ClinicalTrials.gov Identifier: NCT02795962|
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : March 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Direct transfer to an Endovascular Center||Not Applicable|
Prospective, multicenter, cluster randomized controlled, usual care conditions, open, blinded-endpoint trial of acute stroke patients with suspected acute large vessel occlusion (LVO) identified by EMS at first assistance on the field, in which two strategies will be compared: transfer to the closest local stroke center (Local-SC) Vs. direct transfer to an endovascular stroke center (EVT-SC).
The RACE scale (Rapid Arterial oCclusion Evaluation) will be used as a prehospital screening tool to identify acute stroke patients with suspicion of LVO. Upon candidate identification, EMS will contact a stroke neurologist on call using a prehospital telestroke system who will confirm inclusion criteria and will allocate the subjects to a specific intervention according to a pre-established temporal sequence. Allocation will account for 3 strata: time band (two groups of 12 hours), territory (metropolitan versus provincial area) and week day (working versus weekend day).
Subjects will be followed up to 90 days post-randomization.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1754 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Trial Comparing Transfer to the Closest Local Stroke Center vs. Direct Transfer to Endovascular Stroke Center of Acute Stroke Patients With Suspected Large Vessel Occlusion in the Catalan Territory.|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||March 2020|
Active Comparator: Transfer to an Endovascular Center
Acute stroke patients with suspected acute large vessel occlusion identified by EMS at first assistance on the field will be directly transferred to the nearest Endovascular Center bypassing the Local Stroke Center.
Other: Direct transfer to an Endovascular Center
Cluster randomized controlled study: allocation to active or no intervention arm will be performed accordingly to a pre-established temporal sequence
No Intervention: Transfer to the Local Stroke Center
Acute stroke patients with suspected acute large vessel occlusion identified by EMS at first assistance on the field will be transferred to the Local Stroke Center as done accordingly with the current stroke code protocol.
- modified Rankin Scale score (shift analysis) [ Time Frame: 90 days ]Modified Rankin Scale score in ischemic stroke patients as evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment.
- Mortality in all patients [ Time Frame: 90 days ]Mortality in all patients included
- Mortality in hemorrhagic stroke patients [ Time Frame: 90 days ]Mortality in hemorrhagic stroke patients
- Clinical deterioration requiring orotracheal intubation during transfers [ Time Frame: 8 hours ]Orotracheal intubation during transfers
- Clinical deterioration [ Time Frame: 24 hours ]Clinical deterioration (≥4 points on the NIHSS)
- Reperfusion therapies [ Time Frame: 8 hours ]Proportion of patients receiving iv tPA and endovascular treatment within the first 8h from symptom onset
- Time from symptom onset to reperfusion therapies [ Time Frame: 8 hours ]Time from symptom onset to iv tPA administration (for patients treated with iv tPA) and to groin puncture (for patients treated with endovascular).
- Subgroup analysis [ Time Frame: 90 days ]
Distribution of the modified Rankin Scale score at 90 days (shift analysis) in the following subgroups:
- Ischemic / hemorrhagic
- Patients eligible for iv t-PA vs. non iv t-PA eligible when attended by EMS (within time window considering transfer time to the nearest SC, no formal contraindications as recent major surgery or anticoagulation)
- Patients treated with EVT
- Clinical benefit of direct vs. local transfer accordingly with time and distance to the Endovascular Center [ Time Frame: 90 days ]To analyze whether an inflection point exists with respect to time from onset to arrival at the Endovascular Center beyond which transfer to a Local-SC is beneficial or equivalent.
- Dramatic early favorable response [ Time Frame: 24 (-2/+12 hours) ]Dramatic early favorable response as determined by an NIHSS (National Institute of Health Stroke Scale) of 0-2 or NIHSS improvement ≥ 8 points in ischemic stroke and hemorrhagic stroke patients.
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): NCT02795962
|Contact: Natalia Pérez de la Ossa||0034 93 firstname.lastname@example.org|
|Contact: Marc Ribóemail@example.com|
|Hospital Germans Trias i Pujol||Recruiting|
|Contact: Natalia Pérez de la Ossa|
|Contact: Pere Cardona|
|Contact: Xabier Urra|
|Contact: Ana Rodríguez-Campello|
|Hospital Moisés Broggi||Recruiting|
|Contact: Sonia Garcia|
|Hospital Santa Creu i Sant Pau||Recruiting|
|Contact: Joan Martí Fàbregas|
|Hospital Vall d'Hebrón||Recruiting|
|Contact: Marc Ribó|
|Hospital Josep Trueta||Not yet recruiting|
|Contact: Joaquín Serena|
|Hospital Arnau Vilanova||Not yet recruiting|
|Contact: Francisco Purroy|
|Hospital Althaia||Not yet recruiting|
|Contact: Júlia Saura|
|Contact: Jerzy Krupinski|
|Hospital Verge de la Cinta||Not yet recruiting|
|Contact: Josep Zaragoza|
|Principal Investigator:||Marc Ribó, PhD||Hospital Universitari Vall d'Hebrón, Barcelona, Spain|
|Principal Investigator:||Sonia Abilleira, PhD||Pla Director Malaltia Vascular Cerebral. Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS)|
|Principal Investigator:||Natalia Pérez de la Ossa, PhD||Hospital Universitari Germans Trias i Pujol, Badalona, Spain|