Head Position in Stroke Trial

Not Applicable

• Conditions: Acute ischaemic stroke; Acute intracerebral haemorrhage; Stroke - Ischaemic; Stroke - Haemorrhagic

• Registration Number: ACTRN12614000483651
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 19600

Inclusion Criteria

* adults over 18 years ( the age for adults may vary in different countries)
* have a clinical diagnosis of acute stroke (i.e. with a persistent neurological deficit on presentation).
* presentation to hospital including in-hospital event and hospital transfers , with a stroke.

Exclusion Criteria

* transient ischaemic attack (TIA) (i.e. symptoms fully resolved upon presentation).
* definite clinical contraindication or indication to either sitting up head position or lying flat head position.
* 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 Emergency Department (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

Name	Time	Method
Shift (‘improvement’) in death or disability according to the modified Rankin Scale (mRS) [90 days]

Secondary Outcome Measures

Name	Time	Method
Shift in NIH Stroke Scale (NIHSS) score [7 days];Death[Within 90 days];Length of hospital stay[Hospital discharge or death];European Quality of Life Scale 5 Dimension (EQ-5D)[90 days];Pneumonia<br>Hospital acquired pneumonia is defined as pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission; and the presence of a new or progressive radiographic infiltrate plus at least two of three clinical features (fever greater than or equal to 38 degrees, leukocytosis or leukopenia, and purulent secretions).[Within 48 hours]