Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies

Completed

• Conditions: Stroke; Hemorrhagic Stroke; Ischemic Stroke

• Registration Number: NCT04612218
• Lead Sponsor: Hospital Universitario Virgen Macarena

Brief Summary

Stroke is the first cause of death among Spanish women and main cause of disability. Reperfusion therapies of the occluded artery remain the only useful approach in acute ischemic stroke. However, the efficacy of these strategies is highly time-dependent and due to the need of neuroimaging (CT or MRI) to differentiate between ischemic and hemorrhagic stroke, impossible to be performed at the pre-hospital level. The investigators aim to set-up a point of-care (POC) device to validate a biomarker panel differentiating ischemic and hemorrhagic stroke at the pre-hospital level using a blood sample and to validate a second biomarker panel for the early identification of patients with large vessel occlusions (LVO), which are candidates for mechanical thrombectomy. For that, the investigators will recruit a 300 patients' cohort with pre-hospital blood samples using available POCs for each of those markers.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-08
• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-02
• Primary Completion: 2021-07-28
• Study Completion: 2021-07-28
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• I.1: Patients > 18 years old.
• I.2: Stroke code activated by the coordinator centre.
• I.3: < 6 hours from symptoms onset. In the case of stroke with uncertain chronology or wake-up stroke, the initial time will be considered as the last moment the patient was seen fine.

Exclusion Criteria

• E.1: Prehospital diagnosis different of stroke.
• E.2: Impossibility of getting a prehospital blood sample.
• E.3: Refusal to provide the informed consent by the patient/relative.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Times to reperfusion	through study completion, an average of 2 years
Stroke subtype diagnostic accuracy	through study completion, an average of 2 years	Stroke subtype diagnostic (% ischemic versus % hemorrhagic and % stroke mimics) will be determined by clinical and neuroimaging criteria at hospital arrival and compared with diagnostic accuracy of a blood biomarkers based test
Reperfusion rates	through study completion, an average of 2 years

Trial Locations

Locations (4)

Hospital de Alta Resolución Sierra Norte; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital San Juan de Dios Aljarafe; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain