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

NCT06313710 | Completed DMC

• 1 other identifier: Y (2024) 058
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Changes in National Institute of Health stroke scale (NIHSS)

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

  24±8 hours

Secondary Outcomes (12)

• proportion of excellent functional outcome

  90±7 days

• proportion of favorable functional outcome

  90±7 days

• ordinal distribution of modified Rankin Score (mRS)

  90±7 days

• early neurological improvement (ENI)

  24±8 hours

• changes in infarct volume

  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 (3)

control

NO INTERVENTION

low dose of head down position

EXPERIMENTAL

-10° Trendelenburg for 30 min

Other: head down position

high dose of head down position

EXPERIMENTAL

-10° Trendelenburg for 60 min

Other: head down position

Interventions

head down position OTHER

-10° Trendelenburg

high dose of head down position; low dose of head down position

Eligibility Criteria

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

You may qualify if:

• 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.

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;
• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location

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: March 5, 2024
• First Posted: March 15, 2024
• Study Start: August 30, 2024
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

CN (1)