About this trial
The effect of head position as a nonpharmacological therapy on acute ischemic stroke (AIS) remains inconclusive. Recent HOPES2 (Head dOwn-Position for acutE moderate ischemic Stroke with large artery atherosclerosis) suggest the safety, feasibility, and potential benefit of the head-down position (HDP) in acute ischemic stroke. The current study aims to investigate the efficacy and safety of HDP in acute moderate ischemic stroke patients with large artery atherosclerosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old
Acute ischemic stroke confirmed by NCCT or MRI;
Moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours of onset, or progressing from mild (NIHSS ≤ 5) to moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours, requiring ≥ 4 point increase in NIHSS score although the onset time is beyond 24 hours;
Probable large artery atherosclerosis etiology based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria (responsible artery stenosis ≥ 50% or occlusion);
Disqualifiers
Pre-stroke disability (mRS≥3);
Patients with disturbance of consciousness;
Patients who plan to undergo or have completed thrombolysis or mechanical thrombectomy;
Hemorrhagic stroke or combined ischemic and hemorrhagic stroke;
Trial design
Parallel
Treatments tested in this trial
head-down position
Other intervention-20° Trendelenburg as an adjunct to guideline-based treatment,
Treatment groups
Trial outcomes
Primary outcomes
proportion of favorable functional outcome
favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Secondary outcomes
proportion of excellent functional outcome
excellent functional outcome is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
ordinal distribution of modified Rankin Score (mRS)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
early neurological deterioration (END)
END is defined as more than 4-point increase in NIHSS within 48±12 hours, but was not a result of intracerebral hemorrhage
early neurological improvement (ENI)
ENI is defined as more than 4-point decrease in NIHSS within 48±12 hours
Other outcomes
changes in cortical oxygen saturation determined by near infrared spectroscopy
changes in cortical oxygen saturation determined by near infrared spectroscopy
changes in serum biomarkers
changes in serum biomarkers
Sponsors and contacts
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