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An investigator-initiated and conducted, international, multicentre, cluster, randomised cross-over controlled trial to establish the comparative effectiveness of different head positioning in patients with acute stroke

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SLCTR Registration Number

SLCTR/2015/025

Date of Registration

17 Nov 2015

The date of last modification

Oct 13, 2022

Trial Status


Application Summary

Scientific Title of Trial

An investigator-initiated and conducted, international, multicentre, cluster, randomised cross-over controlled trial to establish the comparative effectiveness of different head positioning in patients with acute stroke

Public Title of Trial

Head Position in Stroke Trial

Disease or Health Condition(s) Studied

Acute Ischaemic and Haemorrhagic Stroke

Scientific Acronym

HeadPoST

Public Acronym

HeadPoST

Brief title

Head Position in Stroke Trial

Universal Trial Number

None

Any other number(s) assigned to the trial and issuing authority

ClinicalTrials.gov: NCT02162017 and ANZCTR : ACTRN12614000483651


Trial Details

What is the research question being addressed?

What is the effect of lying flat (0º) head position compared with sitting-up (>30º) head position on functional outcome in patients with Acute Ischemic Stroke?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Masking not used

Control

Active

Assignment

Crossover

Purpose

Treatment

Study Phase

Not Applicable

Intervention(s) planned

Study setting: Acute stroke units in hospitals globally. The study will be carried out in the following centers in Sri Lanka 1. National Hospital of Sri Lanka 2. Sri Jayewardenepura General Hospital 3. Colombo South Teaching Hospital 4. Colombo North Teaching Hospital

Eligible participants will be independently randomized to 2 arms to receive the intervention in the first 24 hours following admission to hospital

Arm A: lying flat (0°) head position first

Arm B: sitting up (>30°) head position first

The randomised intervention is to be considered the new usual nursing care for all acute stroke patients meeting the study criteria as early as possible from the time of presentation in the ED (or from diagnosis if in-hospital event). The site is required to recruit consecutive acute stroke cases in the randomized position until the target number of 70 patients is met before immediately crossing over to the other head position.

Inclusion criteria

  1. Adults aged >18 years (the age for adults may vary in different countries)
  2. Presumed clinical diagnosis of acute stroke (i.e. with a persistent neurological deficit on presentation)
  3. Present to hospital, or have an in-hospital event or transfer from another hospital, with an acute stroke.

Exclusion criteria

  1. Transient ischemic attack (TIA) (i.e. symptoms fully resolved upon presentation)
  2. Definite clinical contraindication or indication to either sitting up or lying flat head positions
  3. Significant medical condition that takes priority in care and where adherence to the randomized head position is not possible on another ward/department of the hospital
  4. 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 randomized head position is not possible.

Primary outcome(s)

1.

A shift (‘improvement’) in death or disability according to the patient’s modified Rankin Scale (mRS) at 90 days.

[

90 days

]

Secondary outcome(s)

1.
  1. A shift in NIHSS score
  2. Death
  3. Length of hospital stay
  4. The European Quality of Life Scale 5 Dimension (EQ-5D)
  5. Pneumonia
 [
  1. 7 days
  2. 90 days
  3. At discharge
  4. At 90 days
  5. Occurrence 48 hours or more after admission, which was not incubating at the time of admission
]

Target number/sample size

700

Countries of recruitment

Australia, Brazil, Chile, China, Colombia, India, Sri Lanka, Taiwan, Province of China, United Kingdom

Anticipated start date

2015-11-17

Anticipated end date

2016-12-31

Date of first enrollment

2015-12-01

Date of study completion

Recruitment status

Complete: follow up complete

Funding source

National Health and Medical Research Council (NMHRC), Australia

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2015-09-09

Approval number

P/131/07/2015

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Kelaniya
Institutional Address:PO Box 6, Thalagolla Road, Ragama Sri Lanka
Telephone:+94-11-2961267
Email: erckelaniya@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Prof Saman Gunatilake
Consultant Neurologist and Professor of Medicine
Colombo South Teaching Hospital, Kalubowila
0112763261


samangunathilake@hotmail.com

Contact Person for Public Queries

Prof Asita De Silva
Director
Clinical Trials Unit, Faculty of Medicine, University of Kelaniya Thalagolla Road, Ragama, Sri Lanka
+94 112665266


asita@remediumone.com

Primary study sponsor/organization

Professor Craig Anderson
Senior Director
The George Institute for Global Health, Sydney, Australia
+61 2 99934521
+61 2 99934501

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

No

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


  • Trial Options