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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02162017




Registration number
NCT02162017
Ethics application status
Date submitted
27/04/2014
Date registered
12/06/2014
Date last updated
9/02/2017

Titles & IDs
Public title
Head Position in Stroke Trial (HeadPoST)
Scientific title
An Investigator Initiated, International Collaborative, Multicentre, Cluster Crossover, Randomised Controlled Trial to Establish the Effects of Head Positioning on Death or Disability in Patients With Acute Stroke
Secondary ID [1] 0 0
X14-0044
Universal Trial Number (UTN)
Trial acronym
HeadPoST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
Intracerebral Haemorrhage 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - The lying flat (0°) head position for 24 hours
Other interventions - The sitting-up (=30°) head position for 24 hours

Experimental: The lying flat intervention - Patients in lying flat intervention to be nursed lying flat (0°) immediately after diagnosis of acute stroke is made and to remain in this position for 24 hours

Active comparator: The sitting-up intervention - Patients in the sitting up intervention to be nursed with their head elevated (=30°) by raising the head of the bed (or with extra pillows or wedge) immediately after the diagnosis of acute stroke is made, and to remain in this position for the next 24 hours


Other interventions: The lying flat (0°) head position for 24 hours
The patients should have strict bed rest for the first 24 hours after admission to hospital. They can be nursed in the side-lying position and feeding should be avoided or only given in the =30° position to reduce the risk of aspiration, and after a standard swallowing screening. Patients should have no more than 3 breaks of 30 minutes in a 30°head position in the first 24 hours, and none of the breaks are to be grouped together (i.e. no back-to back breaks are permitted).

Other interventions: The sitting-up (=30°) head position for 24 hours
For sites that have been randomised to this position, the usual nursing care will be to have patients positioned to sitting-up with the head elevated at 30° or more by raising the head of the bed or use of extra pillows, whatever is the most appropriate, immediately upon presentation to the ED and to remain in that position for 24 hours. Patients should have no more than 3 breaks of 30 minutes in a lying flat head position in the first 24 hours, and none of the breaks are to be grouped together (i.e. no back-to back breaks are permitted).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Shift ('improvement') in death or disability according to the modified Rankin Scale (mRS)
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Shift in NIH Stroke Scale (NIHSS) score
Timepoint [1] 0 0
7 days
Secondary outcome [2] 0 0
Death
Timepoint [2] 0 0
Within 90 days
Secondary outcome [3] 0 0
Length of hospital stay
Timepoint [3] 0 0
up to 90 days
Secondary outcome [4] 0 0
European Quality of Life Scale 5 Dimension (EQ-5D)
Timepoint [4] 0 0
90 days
Secondary outcome [5] 0 0
Pneumonia
Timepoint [5] 0 0
Within 48 hours

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/01/2017
Sample size
Target
Accrual to date
Final
11096
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The George Institute for Global Health - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is 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 (=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.
Trial website
https://clinicaltrials.gov/study/NCT02162017
Trial related presentations / publications
Ouyang M, Roffe C, Billot L, Song L, Wang X, Munoz-Venturelli P, Lavados PM, Robinson T, Middleton S, Olavarria VV, Watkins CL, Lee TH, Brunser AM, Pontes-Neto OM, Hackett ML, Anderson CS. Oxygen desaturation and adverse outcomes in acute stroke: Secondary analysis of the HeadPoST study. Clin Neurol Neurosurg. 2021 Aug;207:106796. doi: 10.1016/j.clineuro.2021.106796. Epub 2021 Jul 6.
Wang X, Moullaali TJ, Ouyang M, Billot L, Sandset EC, Song L, Delcourt C, Hackett ML, Watkins CL, Robinson TG, Yang J, Lavados PM, Brunser A, Olavarria VV, Munoz-Venturelli P, Arima H, Middleton S, Pontes-Neto OM, Pandian JD, Rogers K, Anderson CS. Influence of Including Patients with Premorbid Disability in Acute Stroke Trials: The HeadPoST Experience. Cerebrovasc Dis. 2021;50(1):78-87. doi: 10.1159/000512608. Epub 2021 Jan 12.
Ouyang M, Zhang Y, Wang X, Song L, Billot L, Robinson T, Lavados PM, Arima H, Hackett ML, Olavarria VV, Munoz-Venturelli P, Middleton S, Watkins CL, Pontes-Neto OM, Lee TH, Brunser AM, Anderson CS. Quantifying regional variations in components of acute stroke unit (ASU) care in the international HeadPoST study. J Neurol Sci. 2020 Dec 15;419:117187. doi: 10.1016/j.jns.2020.117187. Epub 2020 Oct 14.
Wang X, Moullaali TJ, Li Q, Berge E, Robinson TG, Lindley R, Zheng D, Delcourt C, Arima H, Song L, Chen X, Yang J, Chalmers J, Anderson CS, Sandset EC. Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome: Pooled Analysis of 20 000+ Patients. Stroke. 2020 Aug;51(8):2411-2417. doi: 10.1161/STROKEAHA.119.028523. Epub 2020 Jul 9.
Brunser AM, Ouyang M, Arima H, Lavados PM, Robinson T, Munoz-Venturelli P, Olavarria VV, Billot L, Hackett ML, Song L, Middleton S, Pontes-Neto O, Lee TH, Watkins C, Anderson CS. No benefit of flat head positioning in early moderate-severe acute ischaemic stroke: a HeadPoST study subgroup analysis. Stroke Vasc Neurol. 2020 Dec;5(4):406-409. doi: 10.1136/svn-2020-000387. Epub 2020 Jun 25.
Munoz Venturelli P, Li X, Middleton S, Watkins C, Lavados PM, Olavarria VV, Brunser A, Pontes-Neto O, Santos TEG, Arima H, Billot L, Hackett ML, Song L, Robinson T, Anderson CS; HEADPOST (Head Positioning in Acute Stroke Trial) Investigators. Impact of Evidence-Based Stroke Care on Patient Outcomes: A Multilevel Analysis of an International Study. J Am Heart Assoc. 2019 Jul 2;8(13):e012640. doi: 10.1161/JAHA.119.012640. Epub 2019 Jun 25.
Minhas JS, Wang X, Lavados PM, Moullaali TJ, Arima H, Billot L, Hackett ML, Olavarria VV, Middleton S, Pontes-Neto O, De Silva HA, Lee TH, Pandian JD, Mead GE, Watkins C, Chalmers J, Anderson CS, Robinson TG; HeadPoST Investigators. Blood pressure variability and outcome in acute ischemic and hemorrhagic stroke: a post hoc analysis of the HeadPoST study. J Hum Hypertens. 2019 May;33(5):411-418. doi: 10.1038/s41371-019-0193-z. Epub 2019 Mar 20.
Billot L, Woodward M, Arima H, Hackett ML, Munoz Venturelli P, Lavados PM, Brunser A, Peng B, Cui L, Song L, Heritier S, Jan S, Middleton S, Olavarria VV, Lim J, Robinson T, Pontes-Neto O, Watkins C, Anderson CS. Statistical analysis plan for the Head Position in Stroke Trial (HeadPoST): An international cluster cross-over randomized trial. Int J Stroke. 2017 Aug;12(6):667-670. doi: 10.1177/1747493017701943. Epub 2017 Mar 24.
Anderson CS, Arima H, Lavados P, Billot L, Hackett ML, Olavarria VV, Munoz Venturelli P, Brunser A, Peng B, Cui L, Song L, Rogers K, Middleton S, Lim JY, Forshaw D, Lightbody CE, Woodward M, Pontes-Neto O, De Silva HA, Lin RT, Lee TH, Pandian JD, Mead GE, Robinson T, Watkins C; HeadPoST Investigators and Coordinators. Cluster-Randomized, Crossover Trial of Head Positioning in Acute Stroke. N Engl J Med. 2017 Jun 22;376(25):2437-2447. doi: 10.1056/NEJMoa1615715.
Munoz-Venturelli P, Arima H, Lavados P, Brunser A, Peng B, Cui L, Song L, Billot L, Boaden E, Hackett ML, Heritier S, Jan S, Middleton S, Olavarria VV, Lim JY, Lindley RI, Heeley E, Robinson T, Pontes-Neto O, Natsagdorj L, Lin RT, Watkins C, Anderson CS; HeadPoST Collaborative Investigators. Head Position in Stroke Trial (HeadPoST)--sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial. Trials. 2015 Jun 5;16:256. doi: 10.1186/s13063-015-0767-1.
Public notes

Contacts
Principal investigator
Name 0 0
Craig S Anderson, MD
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02162017