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Recruiting Observational

Sex diffErences in prehoSpitAl Stroke MEdicine

NCT06865950 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2025-05-01
Last updated
2025-05-21

Condition(s) studied

Stroke AcuteEmergency Medical ServicesSex CharacteristicsPrehospital Setting

Study summary

Background: Stroke is a leading cause for individual, family and societal harm with huge health-economic impact. Immediate and correct prehospital acute stroke pathway initiation is key for treatment success.

Evidence points towards sex inequity in management pathways of acute stroke care. A complicating factor in acute stroke management is the diversity in clinical presentation among patients of different sex. This increases the challenges of correct prehospital identification.

Most of the currently available data on male and female differences in acute stroke management come from patients with hospital-confirmed stroke. Little to no information is available about sex-related management differences of patients with prehospital suspected stroke, often missed by stroke quality databases.

Objectives: To identify sex differences in EMS-delivered prehospital diagnostic accuracy and management of patients with suspected or confirmed acute stroke.

Methods: International project collaboration to conduct a cross-regional cohort analysis of patients with a prehospital working diagnosis of stroke and/or hospital-confirmed stroke diagnosis.

Relevance: More information and details about the reasons for a potential prehospital treatment inequity are a necessary next step for any improvement and subsequent development of structured training programmes for emergency medical service personnel. This project is the first large-scaled international collaboration addressing sex differences in prehospital stroke care. With this approach the project will not only lead to more urgently needed information, but will also serve as a lighthouse project for raising general awareness for this topic.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * For all participants: * Adults aged 18 years of age and older * Emergency call to the national emergency telephone number because of acute symptoms * EMS treatment For cohort 1: \- Working diagnosis of acute stroke or TIA raised by the emergency medical dispatch centre For cohort 2: \- Working diagnosis of acute stroke or TIA raised by the EMS personnel at the emergency site For cohort 3: \- Hospital confirmed diagnosis of acute stroke or TIA Exclusion Criteria: * Patients, who have acute stroke symptoms but do not involve the EMS and make their way to hospital themselves

Primary outcome measure(s)

  • Prehospital management accuracy — 36 hours after emergency call
    Proportion of patients with correct prehospital stroke management defined as correct prehospital working diagnosis compared with hospital diagnosis and adherence to local prehospital stroke guidelines

Trial sites (1)

FacilityCityRegionStatus
Saarland University Homburg Germany Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06865950 on ClinicalTrials.gov ↗ ← All trials in Germany