Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral Hospital of Shenyang Military Region

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • head-down position

    Other intervention

    -20° Trendelenburg as an adjunct to guideline-based treatment,

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Head-down positionExperimental treatment 1 intervention
Group B: controlOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
90±7 days

Secondary outcomes

1

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

Time frame
90±7 days
2

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

Time frame
90±7 days
3

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

Time frame
48±12 hours
4

early neurological improvement (ENI)

ENI is defined as more than 4-point decrease in NIHSS within 48±12 hours

Time frame
48±12 hours

Other outcomes

1

changes in cortical oxygen saturation determined by near infrared spectroscopy

Time frame
24±8 hours
2

changes in cortical oxygen saturation determined by near infrared spectroscopy

Time frame
48±12 hours
3

changes in serum biomarkers

Time frame
48±12 hours
4

changes in serum biomarkers

Time frame
10±2 days

Sponsors and contacts

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