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.

CTA Protocols in a Telestroke Network Improve Efficiency for Both Spoke and Hub Hospitals

“…19 Currently, randomized trials are evaluating the triage option of bypassing the SH for patients whom emergency first responders in the field suspect harbor an ELVO. [20][21][22] The possibility of SH bypass, though promising, has raised concerns regarding care quality at both SHs (decreased patient volumes and local expertise) and hub hospitals (excessive patient volumes straining resources). 18,23 The expansion of the treatment window for thrombectomy to 24 hours raises further unique concerns with triage, given the expanded pool of patients to be evaluated for a progressively smaller number of treatment candidates.…”

Prehospital Triage Strategies for the Transportation of Suspected Stroke Patients in the United States

“… 31 An ongoing randomized clinical trial in Catalonia, Spain, might provide real-world evidence for a triage strategy based on the Rapid Arterial Occlusion Evaluation score. 32 However, these results will only be directly applicable to regions with similar population density, between-center distances and in-hospital workflow times. Modeling studies can be used to translate these results to other regions with different geographic features, while clinical data is needed to optimize the estimates of (time-dependent) treatment efficacy, performance of prehospital stroke scales and model assumptions.…”

Telemedizin in der Schlaganfallversorgung – versorgungsrelevant für Deutschland

“…Ein Zusammenhang der Rate an rekanalisierenden Therapien mit dem Urbanisierungsgrad einer Region unterstreicht die logistischen Schwierigkeiten der Umsetzung leitliniengerechter Therapien [19]. Die Anwendung verschiedener Konzepte über das primär angewandte Drip&Ship-Prinzip hinaus, die noch weiter wissenschaftlich beleuchtet werden müssen, und die zu intensivierende Zusammenarbeit mit dem Rettungsdienst im Hinblick auf eine optimale Transportlogistik stellen aktuelle und zukünftige Aufgaben der Netzwerke dar [24,25].…”