Endovascular Therapy, Stroke, Acute
Conditions
Brief summary
The aim of this trial is to investigate whether head elevation position after endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.
Detailed description
The optimal head position for patients with acute ischemic stroke (AIS) remains uncertain. The HeadPoS study revealed that there is no significant difference in disability outcomes between patients who are placed in a lying-flat position for 24 hours and those who are placed in a sitting-up position with the head elevated to at least 30 degrees for 24 hours. However, this study included both patients with ischemic and hemorrhagic strokes, and most of the patients had mild strokes (median National Institutes of Health Stroke Scale score of 4). It is unclear how to arrange the patient's head position after endovascular treatment. The hypothesis of this trial: Compared with the lying flat head positioni, the head elevation position after endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.
Interventions
OTHERThe lying flat (0°-10°) head position for 72 hours
The lying flat (0°-10°) head position for 72 hours after endovascular therapy.
OTHERThe The head elevation (30°-40°) position for 72 hours
The head elevoatin (30°-40°) position for 72 hours after endovascular therapy.
Sponsors
Zhengzhou Yuan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical signs consistent with acute ischemic stroke; 2. Age ≥ 18 years old; 3. Proved anterior circulation large vessel occlusion on digital subtraction angiography (ICA, M1, M2) with/without cervical lesion (tandem); 4. NIHSS score ≥ 8 points before endovascular treatment; 5. ASPECTS score ≤ 7 points before endovascular treatment; 6. Successful vessel recanalization after endovascular treatment (defined as an eTICI score of 2b, 2c, or 3) ； 7. The time from onset to randomization ≤ 24 hours (the onset time is defined as the last normal time); 8. Written informed consent is obtained from patients and/or their legal representatives.
Exclusion criteria
1. Pre-stroke mRS score\>1 point; 2. Patients with acute occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation); 3. Currently in pregnant or lactating or serum beta HCG test is positive on admission; 4. Contraindications to a flat head position; 5. Any terminal illness with life expectancy less than 6 months; 6. Participating in other clinical trials; 7. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; 8. Unlikely to be available for 90-day follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin scale score (mRS) | 90 days | disability level. The presence of impairments determines the transitions from mRS score 0 to mRS score 1 (symptoms) and mRS score 5 to mRS score 6 (death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients functionally independent (mRS score 0 to 2) at 90 days | Within 90 days90 days | functional independence |
| Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3) | 90 days | ambulatory or bodily needs-capable or better |
| Health-related quality of life, assessed with the EuroQol-visual analogue scales (EQ-VAS) | 90 days | Health-related quality of life |
| Mortality within 90 days | 90 days | evaluate death rate of the two treatment groups |
| severe adverse events | within 90 days | evaluate complications and any adverse events |
| Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1) | 90 days | excellent outcome |
| Any type of intracerebral hemorrhage (Heidelberg Criteria) | within 72 hours after randomized | evaluate intracranial hemorrhage |
| Brain edema | within 72 hours after randomized | evaluate brain edema |
| Malignant Brain Edema | within 72 hours after randomized | evaluate brain edema |
| Incidence of pulmonary infections | within 72 hours after randomized | evaluate pulmonary infections |
| Improvement in National Institute of Health stroke scale (NIHSS) score between baseline and 5~7d | at 5~7 days after randomization | neurological changes. |
| Symptomatic intracerebral hemorrhage incidence (Heidelberg Criteria) | within 72 hours after randomized | evaluate intracranial hemorrhage |
Countries
China
Outcome results
None listed