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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral Hospital of Shenyang Military Region

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • head down position

    Other intervention

    the patient is positioned at a -20° Trendelenburg

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: HDPExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

Changes in cerebral infarct volume

infarct volume was measured by MRI-DWI

Time frame
24±8 hours

Other outcomes

1

changes in dynamic cerebral autoregulation (dCA)

dCA data include phase difference (the main parameter, determined as the phase shift angle ranging from 0° to 90°), gain (difference in the amplitude between CBFV and ABP), and the coherence function (indicates signal-to-noise ratio), which is determined according to previous report (Guo ZN, Guo WT, Liu J, et al. Changes in cerebral autoregulation and blood biomarkers after remote ischemic preconditioning.)

Time frame
24±8 hours
2

changes in cortical oxygen saturation

cortical oxygen saturation is determined by near infrared spectroscopy

Time frame
24±8 hours
3

changes in serum biomarkers

serum biomarkers include MMP-9, TNF-alpha, IL-1beta, etc.

Time frame
24±8 hours

Sponsors and contacts

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