Clinical trial NCT06313710: Head Down Position for Successful Recanalization of Anterior Circulation Large Vessel Occlusion (HOPES4)
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in National Institute of Health stroke scale (NIHSS)
timeFrame: 24±8 hours
Secondary outcomes:
measure: proportion of excellent functional outcome
timeFrame: 90±7 days
measure: proportion of favorable functional outcome
timeFrame: 90±7 days
measure: ordinal distribution of modified Rankin Score (mRS)
timeFrame: 90±7 days
measure: early neurological improvement (ENI)
timeFrame: 24±8 hours
measure: changes in infarct volume
timeFrame: 24±8 hours
measure: changes in cerebral edema
timeFrame: 24±8 hours
measure: Changes in National Institute of Health stroke scale (NIHSS)
timeFrame: 10±2 days
measure: new stroke or other vascular event(s)
timeFrame: 90±7 days
measure: proportion of sympomatic intracranial hemorrhage
timeFrame: 24±8 hours
measure: proportion of intraparenchymal hemorrhage (PH)
timeFrame: 24±8 hours
measure: percentage of severe adverse events
timeFrame: 24±8 hours
measure: all-cause mortality
timeFrame: 90±7 days
Other outcomes:
measure: changes in dynamic cerebral autoregulation (dCA)
timeFrame: 24±8 hours
measure: changes in cortical oxygen saturation
timeFrame: 24±8 hours
measure: changes in serum biomarkers
timeFrame: 24±8 hours
Locations:
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
References: