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

Not Applicable

Not yet recruiting

• Conditions: Ischemic Stroke
• Interventions: Other: head down position

• Registration Number: NCT06313710
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-10
• Study First Posted: 2024-03-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-06
• Last Update Posted: 2024-07-09
• Study Start: 2024-11-10
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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 0.06 seconds 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;
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dose of head down position	head down position	-10° Trendelenburg for 60 min
low dose of head down position	head down position	-10° Trendelenburg for 30 min

Primary Outcome Measures

Name	Time	Method
Changes in National Institute of Health stroke scale (NIHSS)	24±8 hours	the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
ordinal distribution of modified Rankin Score (mRS)	90±7 days	The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
changes in cerebral edema	24±8 hours	cerebral edema is determined by brain imaging
Changes in National Institute of Health stroke scale (NIHSS)	10±2 days	the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
proportion of excellent functional outcome	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
proportion of favorable functional outcome	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
early neurological improvement (ENI)	24±8 hours	ENI is defined as more than 8-point decrease in NIHSS or 0 NIHSS within 24±8 hours
changes in infarct volume	24±8 hours	infarct volume is measured by diffused weighted imaging
all-cause mortality	90±7 days
proportion of intraparenchymal hemorrhage (PH)	24±8 hours	PH was defined as confluent bleeding occupying and causing mass effect
new stroke or other vascular event(s)	90±7 days
proportion of sympomatic intracranial hemorrhage	24±8 hours	sympomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage
percentage of severe adverse events	24±8 hours

Trial Locations

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command; 🇨🇳 Shenyang, China