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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01706094




Registration number
NCT01706094
Ethics application status
Date submitted
11/10/2012
Date registered
15/10/2012
Date last updated
4/12/2015

Titles & IDs
Public title
Head Position in Stroke Trial
Scientific title
Head Position in Stroke Trial
Secondary ID [1] 0 0
HeadPoST1
Universal Trial Number (UTN)
Trial acronym
HeadPoST-Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Head Position

Experimental: lying flat head position - positioning the head of the bed at zero degrees during the first 48 hours from admission of patients with acute ischemic stroke Active Comparator: upright position of the head of the bed during 48 hours from admission of patients with acute ischemic stroke


Other interventions: Head Position
Head position during the first 48 hours from admission of patients with acute ischemic stroke.

This trial is organized as a cluster randomised trial to a policy of flat head position or upright head position. Clusters will be months, so that all patients admitted during a given month will be positioned either in the flat down head position (intervention) or upright head position (control). This will allow health teams to follow a monthly protocol without changing position between patients.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Increased mean cerebral blood flow velocity (CBFV) in the lying flat compared to the upright head position
Timepoint [1] 0 0
24 hours
Secondary outcome [1] 0 0
proportion of Serious adverse events.
Timepoint [1] 0 0
7 days

Eligibility
Key inclusion criteria
* Age 18 or more years old
* Patients with an acute stroke corresponding to anterior circulation, a CT scan ruling out intracranial hemorrhage, presenting within 12 hours from symptom onset
* NIHSS =1
* Susceptible to be tilted down to the flat position or to 30º of the head
* There is uncertainty about the benefit/harm of head position during a minimum of 24 hours.
* Informed consent given
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindications to a flat head position (active vomiting, pneumonia, uncontrolled heart failure)
* Concomitant medical illness that would interfere with outcome assessment and follow-up
* Planned decompressive craniectomy or carotid endarterectomy.
* Absence of sonographic temporal window

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not applicable
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
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Chile
State/province [1] 0 0
Region de Magallanes
Country [2] 0 0
Chile
State/province [2] 0 0
Region Metropolitana

Funding & Sponsors
Primary sponsor type
Other
Name
Clinica Alemana de Santiago
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The George Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A simplest manner to augment cerebral blood flow to irrigate the ischemic penumbra in acute ischemic stroke could be to place the patient in a 'lying flat' rather than upright head position. Given uncertainty over the balance of potential modest benefits and risks, and variability regarding the ideal head position policy for patients with acute ischemic stroke around the world, reliable randomized evidence is required to standardize clinical practice.

The main objectives of this pilot phase clinical trial are to determine the feasibility, safety and potential efficacy of a large-scale cluster randomized clinical trial to assess whether a simple nursing care policy - 'lying flat head position' - provides beneficial effects as compared to the standard upright head position in patients with acute ischemic stroke. The main efficacy outcome of the pilot phase is demonstration of increased mean cerebral blood flow velocity in the flat down compared to the upright head position, as assessed by transcranial Doppler to the medial cerebral arteries of patients with anterior circulation infarction. Secondary efficacy objectives are to demonstrate that the flat down head position improves neurological status at 7 days and disability at 90 days.
Trial website
https://clinicaltrials.gov/study/NCT01706094
Trial related presentations / publications
Olavarria VV, Lavados PM, Munoz-Venturelli P, Gonzalez F, Gaete J, Martins S, Arima H, Anderson CS, Brunser AM. Flat-head positioning increases cerebral blood flow in anterior circulation acute ischemic stroke. A cluster randomized phase IIb trial. Int J Stroke. 2018 Aug;13(6):600-611. doi: 10.1177/1747493017711943. Epub 2017 Jun 5.
Olavarria VV, Arima H, Anderson CS, Brunser A, Munoz-Venturelli P, Billot L, Lavados PM; HEADPOST Pilot Investigators. Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot). Int J Stroke. 2017 Feb;12(2):211-215. doi: 10.1177/1747493016674955. Epub 2016 Oct 14.
Brunser AM, Munoz Venturelli P, Lavados PM, Gaete J, Martins S, Arima H, Anderson CS, Olavarria VV. Head position and cerebral blood flow in acute ischemic stroke patients: Protocol for the pilot phase, cluster randomized, Head Position in Acute Ischemic Stroke Trial (HeadPoST pilot). Int J Stroke. 2016 Feb;11(2):253-9. doi: 10.1177/1747493015620808.
Public notes

Contacts
Principal investigator
Name 0 0
Veronica V Olavarria, MD, Msc
Address 0 0
Clinica Alemana de Santiago, Chile.
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/NCT01706094