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

General Hospital of Shenyang Military Region210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

210

Conditions

Ischemic Stroke

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

early neurologic improvement (ENI)

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

Time frame: 24±8 hours

Secondary Outcomes

proportion of good collateral circulation status

good collateral circulation status was defined as ASITN/SIR grade 3-4.

Time frame: during the first angiography examination

Change in National Institutes of Health Stroke Scale (NIHSS)

the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.

Time frame: Immediately before endovascular treatment

Change in National Institutes of Health Stroke Scale (NIHSS)

the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.

Time frame: 24±8 hours

Changes in cerebral infarct volume

infarct volume was measured by MRI-DWI

Time frame: 24±8 hours

Changes in cerebral edema

change in cerebral edema was measured based on middle shift on CT or MRI

Time frame: 24±8 hours

Change in National Institutes of Health Stroke Scale (NIHSS)

the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.

Time frame: 10±2 days

proportion of modified Rankin Scale (mRS) 0-1

The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

Time frame: 90±7 days

proportion of modified Rankin Scale (mRS) 0-2

The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

Time frame: 90±7 days

ordinal distribution of modified Rankin Scale (mRS)

The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

Time frame: 90±7 days

new stroke or other vascular event(s)

Time frame: 90±7 days

percentage of severe adverse events

Time frame: 24±8 hours

proportion of symptomatic intracranial hemorrhage

symptomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage

Time frame: 24±8 hours

proportion of intraparenchymal hemorrhage (PH)

PH was defined as confluent bleeding occupying and causing mass effect

Time frame: 24±8 hours

all-cause mortality

Time frame: 10±2 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes