Philippine Neurological Association One Database - Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 14,800
- Locations
- 11
- Primary Endpoint
- In-hospital caseload
Study Overview
Brief Summary
This is a pragmatic, multi-center, prospective, observational, non-interventional study and standing database of patients hospitalized for transient ischemic attack (TIA) or stroke in the 11 accredited adult neurology training institutions in the Philippines. Data will be collected from each patient while admitted in the hospital and until hospital discharge. Data collection for this study will span 3 years from study initiation, after which the utility of an extension or a re-implementation of the study will be assessed.
Detailed Description
Primary objective is to prospectively collect data on demographics, medical history, in-hospital management, and outcomes among patients with first or recurrent TIA or ischemic or hemorrhagic stroke admitted in accredited adult neurology training institutions in the Philippines.
Secondary objectives are:
- To determine the in-patient case load of first and recurrent TIA and stroke.
- To determine the profile of patients admitted for first or recurrent TIA or stroke.
- To determine the types of diagnostic and therapeutic management received by patients with first or recurrent TIA or stroke.
- To determine the outcomes of patients with first or recurrent TIA or stroke at the time of hospital discharge.
- To evaluate factors that predict outcome among patients with first or recurrent TIA or stroke.
- To assess and audit the overall quality of care received by patients admitted for first or recurrent TIA or stroke.
- To perform other future analyses, sanctioned by the Philippine Neurological Association (PNA), that may improve knowledge on the care of patients with first and/or recurrent TIA or stroke.
All eligible patients will be assigned a study identification (ID) number and included in the site log kept confidentially in each site. Corresponding anonymized data on demographics, medical history, stroke sub-type, in-hospital management and discharge outcomes will be collected from each patient and entered in the database using a secure online data collection tool.
Collective data will be extracted, summarized, and analyzed for the secondary objectives every year with oversight provided by the Philippine Neurological Association.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of first or recurrent TIA, ischemic or hemorrhagic stroke, or cerebral venous thrombosis (CVT)
- •18 years old or older
- •Admitted in the participating hospital
- •If required by the institutional review board/ethics committee, signed or verbal informed consent for participation in the study from the patient or a legal representative
Exclusion Criteria
- •Patients with previous TIA or stroke who are admitted to the hospital for medical conditions other than an acute stroke, e.g., patient with non-acute stroke admitted for pneumonia, rehabilitation, or procedures, such as gastric tube insertion, etc.
- •Any condition which, in the study investigator's opinion, may jeopardize the patient by his/her participation in this study or affect the validity of the study results
Outcomes
Primary Outcomes
In-hospital caseload
Time Frame: 3 years
Number of TIA and stroke cases admitted in participating sites.
Secondary Outcomes
- In-hospital therapeutic management (anti-thrombotics)(From admission to discharge, may be up to 1 month)
- Functional status at hospital discharge(At discharge, may be up to 1 month)
- In-hospital diagnostic procedures (electrocardiogram)(From admission to discharge, may be up to 1 month)
- In-hospital therapeutic management (thrombolysis)(From admission to discharge, may be up to 1 month)
- In-hospital diagnostic procedure (brain scan)(From admission to discharge, may be up to 1 month)
- In-hospital diagnostic procedures (echocardiogram)(From admission to discharge, may be up to 1 month)
- In-hospital diagnostic procedures (cerebral vascular studies)(From admission to discharge, may be up to 1 month)
- In-hospital therapeutic management (rehabilitation)(From admission to discharge, may be up to 1 month)
- In-hospital complications from TIA or stroke(From admission to discharge, may be up to 1 month)
- Neurological status at hospital discharge(At discharge, may be up to 1 month)
- Vital status at hospital discharge(At discharge, may be up to 1 month)