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

NCT ID: NCT07172789

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-02
• Study Completion Date: 2026-09-30

Brief Summary

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HDP

the HDP group receive -20° Trendelenburg prior endovascular treatment.

Group Type: EXPERIMENTAL

head down position

Intervention Type: OTHER

the patient is positioned at a -20° Trendelenburg

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

head down position

the patient is positioned at a -20° Trendelenburg

Intervention Type: OTHER

Other Intervention Names

Trendelenburg

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hui-Sheng Chen

Shenyang, None Selected, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zi-Ai Zhao, Ph.D.

Role: primary

zhaoziai@hotmail.com

86-2428897517

Other Identifiers

Y (2025) 320

Identifier Type: -

Identifier Source: org_study_id