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Head Position in Acute Stroke Trial

Phase 3
Conditions
Health Condition 1: null- All acute stroke patients admitted to the hospital
Registration Number
CTRI/2016/03/006738
Lead Sponsor
ational Health and Medical Research Council of Australia
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
19500
Inclusion Criteria

•are adults aged greater than or equal to 18 years(the age for adults may vary in different countries)

•have a presumed clinical diagnosis of acute stroke (i.e. with a persistent neurological deficit on presentation),

•present to hospital, or have an in-hospital event or transfer from another hospital, with acute stroke.

Exclusion Criteria

•transient ischaemic attack (TIA) (i.e. symptoms have resolved upon presentation),

•definite clinical contraindication or indication to either the sitting up or lying flat head positions,

•significant medical condition that takes priority in care and where adherence to the randomised head position is not possible on another ward/department of the hospital,

•immediate transfer from the ED or admission, to another ward for medical treatment (e.g. for haemodialysis) or surgery (e.g. carotid endarterectomy, haematoma evacuation) where adherence to the randomised head position is not possible.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
primary outcome will be a shift (improvement) in death and disability according to the patientâ??s modified Rankin Score (mRS) at 90 days.Timepoint: 90 days
Secondary Outcome Measures
NameTimeMethod
1.Death or dependency measured by a shift in NIHSS(46) at 7 days <br/ ><br>2.Death within 90 days <br/ ><br>3.Length of hospital stay <br/ ><br>4.the European Quality of Life Scale 5 Dimension (EQ-5D) <br/ ><br>5.Pneumonia according to standard criteria involving a set combination of symptomatology and radiological signs <br/ ><br>Timepoint: 1. Death or dependency at 7 days <br/ ><br>2. Death within 90 days <br/ ><br>3. Pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission
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