Head dOwn Position Before Endovascular Treatment for Large veSsel Occlusion (HOPES5)

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status

Enrolling

Conditions

Ischemic Stroke

Treatments

Other: head down position

Study type

Interventional

Funder types

Other

Identifiers

NCT07172789

Y (2025) 320

Details and patient eligibility

About

Recent studies suggest that head-down positioning (HDP) intervention may improve outcomes in ischemic stroke. In the era of reperfusion therapy, a key protective strategy is to administer neuroprotective interventions before recanalization to reduce the loss of the ischemic penumbra, thereby salvaging more penumbral tissue after revascularization and ultimately improving clinical outcomes. Based on this concept, and considering the neuroprotective effects of HDP, the investigators hypothesize that HDP intervention prior to endovascular therapy (EVT) in patients with large vessel occlusion could improve clinical outcomes. This hypothesis is further supported by a recent clinical study (NCT03728738), which demonstrated that compared to a sitting up position (30°), a flat supine position (0°) before EVT significantly reduced the incidence of neurological deterioration prior to the procedure. Building on the above rationale, this trial aims to investigate the efficacy and safety of HDP intervention prior to EVT in patients with large vessel occlusion.

Enrollment

210 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.