Abstract
BackgroundPositioning a patient lying-flat in the acute phase of ischaemic stroke may improve recovery and reduce disability, but such a possibility has not been formally tested in a randomised trial. We therefore initiated the Head Position in Stroke Trial (HeadPoST) to determine the effects of lying-flat (0°) compared with sitting-up (≥30°) head positioning in the first 24 hours of hospital admission for patients with acute stroke.Methods/DesignWe plan to conduct an international, cluster randomised, crossover, open, blinded outcome-assessed clinical trial involving 140 study hospitals (clusters) with established acute stroke care programs. Each hospital will be randomly assigned to sequential policies of lying-flat (0°) or sitting-up (≥30°) head position as a ‘business as usual’ stroke care policy during the first 24 hours of admittance. Each hospital is required to recruit 60 consecutive patients with acute ischaemic stroke (AIS), and all patients with acute intracerebral haemorrhage (ICH) (an estimated average of 10), in the first randomised head position policy before crossing over to the second head position policy with a similar recruitment target. After collection of in-hospital clinical and management data and 7-day outcomes, central trained blinded assessors will conduct a telephone disability assessment with the modified Rankin Scale at 90 days. The primary outcome for analysis is a shift (defined as improvement) in death or disability on this scale. For a cluster size of 60 patients with AIS per intervention and with various assumptions including an intracluster correlation coefficient of 0.03, a sample size of 16,800 patients at 140 centres will provide 90 % power (α 0.05) to detect at least a 16 % relative improvement (shift) in an ordinal logistic regression analysis of the primary outcome. The treatment effect will also be assessed in all patients with ICH who are recruited during each treatment study period.DiscussionHeadPoST is a large international clinical trial in which we will rigorously evaluate the effects of different head positioning in patients with acute stroke.Trial registrationClinicalTrials.gov identifier: NCT02162017 (date of registration: 27 April 2014); ANZCTR identifier: ACTRN12614000483651 (date of registration: 9 May 2014). Protocol version and date: version 2.2, 19 June 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0767-1) contains supplementary material, which is available to authorized users.
Highlights
Positioning a patient lying-flat in the acute phase of ischaemic stroke may improve recovery and reduce disability, but such a possibility has not been formally tested in a randomised trial
HeadPoST is a large international clinical trial in which we will rigorously evaluate the effects of different head positioning in patients with acute stroke
The key secondary aims are to determine whether lying-flat (0°) is superior to sitting-up (≥30°) with regard to poor outcome at 7 days in patients with Acute ischaemic stroke (AIS), whether sitting-up (≥30°) is superior to lying-flat (0°) on early and late outcomes and early neurological recovery (NIHSS at 7 days) in acute intracerebral haemorrhage (ICH), the effects of the two head positions on overall and causespecific death separately by 7 and 90 days, serious adverse events (SAEs) and length of hospital stay
Summary
If positioning the patient in the acute phase of stroke has a significant beneficial effect on outcome, there is potential to have a major public health impact for a widely generalisable, affordable health care intervention. International coordinating centre The InCC is supported by key grantholders and project staff It is responsible for day-to day management of the study, data and project management, committee coordination, assistance with ethics committee applications, protocol and procedures for training of participating sites, overseeing of initiation visits and activation of participating sites, monitoring of data quality and adherence to protocol, adherence to applicable guidelines and regulations, and preparation of study data for analysis and publication. A DSMB will review unblinded data at regular intervals during follow-up and will monitor neurological and functional changes (between the two groups), as well as dropout and event rates These DSMB members will use the approach developed by Sir Richard Peto for safety monitoring and will provide reports to the InCC on recommendations to continue or temporarily halt recruitment into the study.
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