Sex diffErences in prehoSpitAl Stroke MEdicine

NCT06865950 | Recruiting

• 1 other identifier: SESAME_137/2024
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke Acute; Emergency Medical Services; Sex Characteristics; Prehospital Setting

Keywords

stroke; sex differences; ambulance service; stroke treatment; inequality

Outcome Measures

Primary Outcomes (1)

• Prehospital management accuracy

  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

  36 hours after emergency call

Study Arms (3)

Dispatch centre suspected stroke patients

Patients with dispatch centre suspected acute stroke diagnosis, who therefore had a code stroke dispatch

Patients with EMS on scene suspected acute stroke diagnosis

Patients for which the EMS at the emergency side suspects an acute stroke diagnosis and deliver the EMS stroke protocol treatment.

Patients with hospital confirmed acute stroke diagnosis

Patient who received a final hospital diagnosis of stroke after full diagnostic work-up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients for cohorts 1 and 2 patients will be identified through information coming from the prehospital patient records. All patients with prehospital suspected diagnosis of stroke or TIA will be considered. Terminology will be adjusted to local terms. Cohort 3 patients will be identified in the stroke department if diagnosed with stroke (ischaemic or haemorrhagic) or TIA.

You may qualify if:

• 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

You may not qualify if:

• Patients, who have acute stroke symptoms but do not involve the EMS and make their way to hospital themselves

Sponsors & Collaborators

• Universität des Saarlandes: lead
• East of England Ambulance Service NHS Trust: collaborator
• Norwegian Air Ambulance Foundation: collaborator
• Glasgow Caledonian University: collaborator
• Assiut University: collaborator
• The George Institute: collaborator
• Hospital de Clinicas de Porto Alegre: collaborator
• Hospital Israelita Albert Einstein: collaborator
• University Of Perugia: collaborator
• University "Ss Cyril and Methodius", North Macedonia: collaborator
• 115 People's Hospital: collaborator
• Selcuk University: collaborator
• Copenhagen University Hospital, Denmark: collaborator
• National University Hospital, Singapore: collaborator
• Kwame Nkrumah University of Science and Technology, Ghana: collaborator
• Catholic University of Health and Allied Sciences, Mwanza, Tansania: collaborator

Study Sites (1)

Saarland University

Homburg, Germany

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Silke Walter, Consultant Neurologist

CONTACT

+49-6841-1626515; silke.walter@uks.eu

Brittany Wells, Paramedic

CONTACT

brittany.wells@gcu.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: March 10, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)