Using head down position to improve outcomes in stroke patients after treatment

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

This study is testing if putting stroke patients in a head down position after treatment can help them recover better and improve blood flow to their brain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (Academic / other)
• Locations: 1 site (Shenyang)
• Trial ID: NCT06313710 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effect of positioning patients in a head down position after they have undergone endovascular treatment for anterior circulation large vessel occlusion due to ischemic stroke. It is a prospective, randomized, open-label study conducted at a single center, focusing on patients who have achieved successful recanalization. The study aims to determine if this positioning can enhance recovery and improve cerebral circulation in these patients. Participants will be monitored for outcomes related to their stroke recovery following the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with anterior circulation large vessel occlusion who have received timely endovascular treatment and achieved successful recanalization.

Not a fit: Patients with hemorrhagic strokes or significant hepatic or renal dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved recovery outcomes for stroke patients after endovascular treatment.

How similar studies have performed: While this specific approach is novel, similar studies exploring positioning in stroke recovery have shown promising results.

Eligibility criteria

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.

Where this trial is running

Shenyang

• Department of Neurology, General Hospital of Northern Theater Command — Shenyang, China (Recruiting)

Conditions Ischemic Stroke