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Sex diffErences in prehoSpitAl Stroke MEdicine

Study acronym: SESAME
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 1, 2025 to May 1, 2025
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06865950
Lead Sponsor Universität des Saarlandes
Collaborators: East of England Ambulance Service NHS Trust, Norwegian Air Ambulance Foundation, Glasgow Caledonian University, Assiut University, The George Institute, Hospital de Clinicas de Porto Alegre, Hospital Israelita Albert Einstein, University Of Perugia, Ss. Cyril and Methodius University of Skopje, 115 People's Hospital, Selcuk University, Copenhagen University Hospital, Denmark, National University Hospital, Singapore, Kwame Nkrumah University of Science and Technology, Catholic University of Health and Allied Sciences, Mwanza, Tansania
Conditions
(from sponsor)		 Stroke Acute, Emergency Medical Services, Sex Characteristics, Prehospital Setting
Related terms Stroke
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov