Transfer to the Local Stroke Center versus Direct Transfer to Endovascular Center of Acute Stroke Patients with Suspected Large Vessel Occlusion in the Catalan Territory (RACECAT): Study protocol of a cluster randomized within a cohort trial

Abstract

Rationale

Optimal pre-hospital delivery pathways for acute stroke patients suspected to harbor a large vessel occlusion have not been assessed in randomized trials.

Aim

To establish whether stroke subjects with rapid arterial occlusion evaluation scale based suspicion of large vessel occlusion evaluated by emergency medical services in the field have higher rates of favorable outcome when transferred directly to an endovascular center (endovascular treatment stroke center), as compared to the standard transfer to the closest local stroke center (local-SC).

Design

Multicenter, superiority, cluster randomized within a cohort trial with blinded endpoint assessment.

Procedure

Eligible patients must be 18 or older, have acute stroke symptoms and not have an immediate life threatening condition requiring emergent medical intervention. They must be suspected to have intracranial large vessel occlusion based on a pre-hospital rapid arterial occlusion evaluation scale of ≥5, be located in geographical areas where the default health authority assigned referral stroke center is a non-thrombectomy capable hospital, and estimated arrival at a thrombectomy capable stroke hospital in less than 7 h from time last seen well. Cluster randomization is performed according to a pre-established temporal sequence (temporal cluster design) with three strata: day/night, distance to the endovascular treatment stroke center, and week/week-end day.

Study outcome

The primary endpoint is the modified Rankin Scale score at 90 days. The primary safety outcome is mortality at 90 days.

Analysis

The primary endpoint based on the modified intention-to-treat population is the distribution of modified Rankin Scale scores at 90 days analyzed under a sequential triangular design. The maximum sample size is 1754 patients, with two planned interim analyses when 701 (40%) and 1227 patients have completed follow-up. Hypothesized common odds ratio is 1.35.

Keywords

Acute stroke large vessel occlusion pre-hospital transfer models drip and ship mother ship clinical trial

Get full access to this article

View all access options for this article.

References

The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group (NINDS Group). Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med 1995; 333: 1581–1587.

Ribo

Alvarez-Sabín

Montaner

, et al. Temporal profile of recanalization after intravenous tissue plasminogen activator: selecting patients for rescue reperfusion techniques. Stroke 2006; 37: 1000–2.

Saqqur

Uchino

Demchuk

, et al. Site of arterial occlusion identified by transcranial Doppler predicts the response to intravenous thrombolysis for stroke. Stroke 2007; 38: 948–2.

Goyal

Menon

Van Zwam

, et al. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet 2016, pp. 387: 1723–1731.

Pérez De La Ossa

Abilleira

Dorado

, et al. Access to endovascular treatment in remote areas: analysis of the reperfusion treatment Registry of Catalonia. Stroke 2016; 47: 1381–1384. http://europepmc.org/abstract/med/27032445.

Carrera D, Gorchs M, Querol M, et al. for the Catalan Stroke Code and Reperfusion Consortium (Cat-SCR). doi: 10.1136/neurintsurg-2018-014519.

Saver

Goyal

Van Der Lugt

, et al. Time to treatment with endovascular thrombectomy and outcomes from ischemic stroke: a meta-analysis. JAMA 2016; 316: 1279–1288.

Pérez de La Ossa

Carrera

Gorchs

, et al. Design and validation of a prehospital stroke scale to predict large arterial occlusion: the rapid arterial occlusion evaluation scale. Stroke 2014; 45: 87–91.

Vivanco-Hidalgo

Abilleira

Salvat-Plana

Ribera

Gallofré

. Innovation in systems of care in acute phase of ischemic stroke. The experience of the Catalan stroke programme. Front Neurol 2018, pp. 9: 427.

10.

Todd

. A 25-year review of sequential methodology in clinical studies. Stat Med 2007; 26: 237–252.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.69 MB