Head Position in Acute Stroke Trial

Phase 3

Recruiting

• Conditions: All acute stroke patients admitted to the hospital

• Registration Number: CTRI/2016/03/006738
• Lead Sponsor: National Health and Medical Research Council of Australia

Brief Summary

**OBJECTIVE:**An investigator-initiated and conducted, international collaborative, regionally organised, multicentre, prospective, cluster randomised crossover blinded outcome assessment study to compare the effectiveness of the lying flat (0°) head position with the sitting up (greater than or equal to 30°) head position, in the first 24 hours of admission to hospital for patients with acute stroke, on the poor outcome of death or disability over the subsequent 90 days.

**AIMS:***Primary -* to compare the effects of lying flat (0°) head position with sitting up (greater than or equal to 30°) head position applied in the first 24 hours of admission, for patients presenting with AIS, on the poor outcome of death or disability at 90 days.  S*econdary* - to determine whether lying flat is superior to sitting up on poor outcome (death and neurological impairment) at 7 days in AIS; and whether sitting up is superior to lying flat on these outcomes in acute ICH.

**DESIGN:**  A multicentre, prospective, cluster randomised crossover, blinded outcome assessment study through a global network of investigators.

**STUDY CRITERIA:***Included patients are those that:*

·       are adults aged 18 years or over  (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 an acute stroke.

*Excluded patients are those with:*

·        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.

**RANDOMISATION** **OF STUDY SITES****:**The unit of randomisation will be the site (hospital), which will be randomly assigned by a statistician not otherwise involved in the trial to (a) lying flat (0°) head position first or (b) sitting up (greater than or equal to 30°) head position first, by country of thesite. Each site will participate in both head positions.

**OUTCOMES:** *Primary clinical outcome* is a shift (‘improvement’) in death or disability according to the modified Rankin Scale (mRS) at 90 days. *Secondary outcomes* area shift in NIHSS score at 7 days; death within 90 days; length of stay; the European Quality of Life Scale 5 Dimension (EQ-5D); and pneumonia.  All SAEs that occur up until the 90-day follow-up will be prospectively reported, monitored and reviewed according to standard criteria.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-24
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• 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

Name	Time	Method
primary outcome will be a shift (improvement) in death and disability according to the patient’s modified Rankin Score (mRS) at 90 days.	90 days

Secondary Outcome Measures

Name	Time	Method
1.Death or dependency measured by a shift in NIHSS(46) at 7 days	2.Death within 90 days

Trial Locations

Locations (7)

All India Institute for Medical Sciences; 🇮🇳 West, DELHI, India

Baby Memorial Hospital Limited; 🇮🇳 Kozhikode, KERALA, India

CMC Ludhiana; 🇮🇳 Ludhiana, PUNJAB, India

Dr. Ramesh Cardiac & Multispecialty Hospital Pvt. Limited; 🇮🇳 Guntur, ANDHRA PRADESH, India

Mazumdar Shaw Medical Center, a unit of Narayana Hrudayalaya Limited; 🇮🇳 Bangalore, KARNATAKA, India

National Institute of Mental Health and Neurosciences; 🇮🇳 Bangalore, KARNATAKA, India

Sree Chitra Tirunal Institute for Medical Sciences and Technology; 🇮🇳 Thiruvananthapuram, KERALA, India

All India Institute for Medical Sciences

🇮🇳West, DELHI, India

Dr MV Padma

Principal investigator

9810819167

vasanthapadma123@gmail.com