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Completed

NCT Number: NCT06313710

Head Down Position for Successful Recanalization of Anterior Circulation Large Vessel Occlusion (HOPES4)

This is a prospective, randomized, open label, blinded-end point, single-center study, aiming to investigate the effect of head down position in anterior circulation large vessel occlusion patients with successful recanalization after endovascular treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • Anterior circulation large vessel occlusion who received endovascular treatment within 24 hours of stroke onset;
  • National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment;
  • Successful recanalization (mTICI 2b-3) after endovascular treatment;
  • Cerebral circulation time based on DSA of the stroke side was slower than that of the healthy side after successful recanalization;
  • ASPECTS ≥ 6 on CT or DWI;
  • Absence of parenchymal hematoma on CT images done in the angio suite immediately after the procedure;
  • 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;
  • After recanalization, severe and sustained (i.e., > 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication;
  • More than four retrieval attempts in the same vessel;
  • Cardiac insufficiency (NYHA Class ≥II);
  • Pregnancy, plan to get pregnant or during lactation;
  • The estimated life expectancy is less than 6 months due to other serious diseases;
  • Other conditions unsuitable for this clinical study assessed by researcher.

Treatment and study plan

head down position

Other

-10° Trendelenburg

Primary outcomes

  1. Changes in National Institute of Health stroke scale (NIHSS)

    Time frame: 24±8 hours

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

Secondary outcomes

  1. proportion of excellent functional outcome

    Time frame: 90±7 days

    excellent functional outcome is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

  2. proportion of favorable functional outcome

    Time frame: 90±7 days

    favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

  3. ordinal distribution of modified Rankin Score (mRS)

    Time frame: 90±7 days

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

  4. early neurological improvement (ENI)

    Time frame: 24±8 hours

    ENI is defined as more than 8-point decrease in NIHSS or 0 NIHSS within 24±8 hours

  5. changes in infarct volume

    Time frame: 24±8 hours

    infarct volume is measured by diffused weighted imaging

  6. changes in cerebral edema

    Time frame: 24±8 hours

    cerebral edema is determined by brain imaging

  7. Changes in National Institute of Health stroke scale (NIHSS)

    Time frame: 10±2 days

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

  8. new stroke or other vascular event(s)

    Time frame: 90±7 days

  9. proportion of sympomatic intracranial hemorrhage

    Time frame: 24±8 hours

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

  10. proportion of intraparenchymal hemorrhage (PH)

    Time frame: 24±8 hours

    PH was defined as confluent bleeding occupying and causing mass effect

  11. percentage of severe adverse events

    Time frame: 24±8 hours

  12. all-cause mortality

    Time frame: 90±7 days

Other outcomes

  1. changes in dynamic cerebral autoregulation (dCA)

    Time frame: 24±8 hours

    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.)

  2. changes in cortical oxygen saturation

    Time frame: 24±8 hours

    cortical oxygen saturation is determined by near infrared spectroscopy

  3. changes in serum biomarkers

    Time frame: 24±8 hours

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

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Head Down Position for Successful Recanalization of Anterior Circulation Large Vessel Occlusion (HOPES3): a Prospective, Randomized, Open Label, Blinded-end Point, Single-center Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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