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

Официальное название

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

Обзор

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.

Вмешательства

• Другое head down position
  the patient is positioned at a -20° Trendelenburg

Первичные конечные точки

• early neurologic improvement (ENI) [Срок оценки: 24±8 hours]

Вторичные конечные точки (12)

• proportion of good collateral circulation status [Срок оценки: during the first angiography examination]
• Change in National Institutes of Health Stroke Scale (NIHSS) [Срок оценки: Immediately before endovascular treatment]
• Change in National Institutes of Health Stroke Scale (NIHSS) [Срок оценки: 24±8 hours]
• Changes in cerebral infarct volume [Срок оценки: 24±8 hours]
• Changes in cerebral edema [Срок оценки: 24±8 hours]
• Change in National Institutes of Health Stroke Scale (NIHSS) [Срок оценки: 10±2 days]
• proportion of modified Rankin Scale (mRS) 0-1 [Срок оценки: 90±7 days]
• proportion of modified Rankin Scale (mRS) 0-2 [Срок оценки: 90±7 days]
• ordinal distribution of modified Rankin Scale (mRS) [Срок оценки: 90±7 days]
• new stroke or other vascular event(s) [Срок оценки: 90±7 days]
• percentage of severe adverse events [Срок оценки: 24±8 hours]
• proportion of symptomatic intracranial hemorrhage [Срок оценки: 24±8 hours]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Hui-Sheng Chen — Шэньян

Публикации

• Fei ZX, Dai YJ, Wang XH, Chen HS. Head Down Position Before Endovascular Treatment for Large Vessel Occlusion: Clinical Trial Design. J Am Heart Assoc. 2026 Mar 17;15(6):e046853. doi: 10.1161/JAHA.125.046853. Epub 2026 Mar 4. PMID 41778610

Идентификаторы

NCT: NCT07172789 · Y (2025) 320

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗