Head-down positioning before clot removal for large-vessel ischemic stroke.

Head dOwn Position Before Endovascular Treatment for Large veSsel Occlusion (HOPES5): a Prospective, Randomized, Open Label, Blinded-end Point, Multi-center Study

This trial will test whether placing adults with large-vessel ischemic stroke in a head-down position before endovascular clot removal helps protect brain tissue and improve recovery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (other)
• Locations: 1 site (Shenyang, None Selected)
• Trial ID: NCT07172789 on ClinicalTrials.gov

What this trial studies

This interventional trial tests whether head-down positioning (HDP) applied before endovascular thrombectomy can reduce early neurological deterioration and increase salvage of the ischemic penumbra. Eligible patients are adults with acute large-vessel occlusion within 24 hours, NIHSS ≥ 6, and ASPECTS/pc-ASPECTS ≥ 6 who expect more than a 30-minute wait before femoral artery puncture. Participants will receive HDP prior to the procedure and will be monitored for clinical outcomes and safety events compared with usual positioning. The trial builds on prior work showing benefit from flat supine positioning and seeks to determine whether a head-down tilt provides additional neuroprotection prior to recanalization.

Who should consider this trial

Good fit: Adults aged 18 or older with acute large-vessel occlusion scheduled for endovascular thrombectomy within 24 hours, NIHSS ≥ 6, ASPECTS/pc-ASPECTS ≥ 6, pre-stroke mRS ≤ 1, and an expected wait from randomization to femoral puncture of more than 30 minutes are the intended participants.

Not a fit: Patients with hemorrhagic stroke, severe hepatic or renal dysfunction, uncontrolled severe hypertension, significant cardiac insufficiency (NYHA ≥ II), or pregnancy (and other listed exclusions) are not expected to benefit and are excluded from participation.

Why it matters

Potential benefit: If effective, pre-procedure head-down positioning could reduce early neurological worsening and increase the amount of brain tissue saved, leading to better functional outcomes after large-vessel stroke.

How similar studies have performed: A recent clinical trial (NCT03728738) found that a flat supine position reduced pre-procedure neurological deterioration versus sitting, supporting the concept, but head-down positioning before EVT remains relatively novel and less tested.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years;
* Patients with acute large vessel occlusion scheduled for endovascular thrombectomy within 24 hours of symptom onset;
* Baseline National Institute of Health Stroke Scale (NIHSS) ≥ 6;
* Expected waiting time from randomization to femoral artery puncture is more than 30 minutes;
* ASPECTS/pc-ASPECTS score ≥ 6 on baseline non-contrast CT or DWI;
* Modified Rankin Scale score before stroke onset ≤ 1;
* Signed informed consent by patient or their legally authorized representative.

Exclusion Criteria:

* Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
* Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
* Severe hypertension before randomization (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg);
* Cardiac insufficiency (NYHA Class ≥II);
* Pregnancy, plan to get pregnant or during lactation;
* Patients at significant risk of aspiration (e.g., obvious nausea and vomiting);
* The estimated life expectancy is less than 6 months due to other serious diseases;
* Other conditions unsuitable for this clinical study assessed by researcher.

Where this trial is running

Shenyang, None Selected

• Hui-Sheng Chen — Shenyang, None Selected, China (RECRUITING)

Conditions: Ischemic Stroke