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

NCT07172789 | Recruiting DMC

• 1 other identifier: Y (2025) 320
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• early neurologic improvement (ENI)

  ENI was defined as more than 4-point decrease in NIHSS within 24±8 hours;

  24±8 hours

Secondary Outcomes (14)

• proportion of good collateral circulation status

  during the first angiography examination

• Change in National Institutes of Health Stroke Scale (NIHSS)

  Immediately before endovascular treatment

• Change in National Institutes of Health Stroke Scale (NIHSS)

  24±8 hours

• Changes in cerebral infarct volume

  24±8 hours

• Changes in cerebral edema

  24±8 hours

Other Outcomes (3)

• changes in dynamic cerebral autoregulation (dCA)

  24±8 hours

• changes in cortical oxygen saturation

  24±8 hours

• changes in serum biomarkers

  24±8 hours

Study Arms (2)

HDP

EXPERIMENTAL

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

Other: head down position

Control

NO INTERVENTION

Interventions

head down position OTHER

the patient is positioned at a -20° Trendelenburg

Also known as: Trendelenburg

HDP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Hui-Sheng Chen

Shenyang, None Selected, 110016, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Head-Down Tilt

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 15, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

CN (1)