Trial Review

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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
NA
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
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
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01706094