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NCT04157231 | NOT YET RECRUITING | Acute Stroke

Essential Acute Stroke Care in Low Resource Settings: a Pilot studY
Sponsor:

The George Institute

Brief Summary:

An investigator-initiated, evaluator-blinded, prospective, multi centre, before-and-after, effectiveness-implementation hybrid design study to assess the feasibility of essential acute stroke care in a low resource setting

Condition or disease

Acute Stroke

Intervention/treatment

Acute stroke care Intervention arm

Phase

NA

Detailed Description:

This is a multicentre, before and after, effectiveness-implementation hybrid study design with blinded outcome assessment. Patients admitted to the participating hospitals will be managed under usual care conditions for three months (control arm). This will be followed by the training of the doctors and nurses in those hospitals on essential acute stroke care management. Patient management for the following three months after the training (intervention) will then be assessed to evaluate its impact on the care and clinical outcome of the patients.

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : SINGLE
Masking Description : The clinical outcome will be assessed by a blinded assessor
Primary Purpose : SUPPORTIVE_CARE
Official Title : Essential Acute Stroke Care in Low Resource Settings: a Pilot Study
Actual Study Start Date : 2025-12-30
Estimated Primary Completion Date : 2027-06-30
Estimated Study Completion Date : 2027-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Adults (age ≥18 years)
  • * A clinical or imaging-based diagnosis of acute stroke (ischemic or haemorrhagic) within 72 hours of stroke symptom onset
  • * Provision of written informed consent
  • * Subjects in observational, natural history and/or epidemiological studies not involving an intervention are eligible.
Exclusion Criteria
  • * Patients who have undergone intravenous thrombolysis or mechanical thrombectomy
  • * Patients who are planned for transfer to the intensive care unit
  • * Subarachnoid haemorrhage
  • * Participation in an interventional medical investigation or clinical trial currently or within the past 3 months.
Essential Acute Stroke Care in Low Resource Settings: a Pilot studY

Location Details

NCT04157231

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Nigeria, Kano State

Murtala Muhammad Specialist Hospital

Kano, Kano State, Nigeria, 3200

Not yet recruiting

Nigeria, Kogi State

Federal Medical Centre

Side bypass, Kogi State, Nigeria, 1001

Not yet recruiting

Peru,

I-2 Sullana Support Hospital

Piura, Peru,

Not yet recruiting

Peru,

PERU COREA SANTA ROSA II-2 Friendship Hospital

Piura, Peru,