HeadSOAR: Head Position After Endovascular Therapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: The lying flat group Patients in lying flat intervention to be nursed lying flat (0°) after endovascular therapy is made and to remain in this position for 72 hours. |
Other: The lying flat (0°) head position for 72 hours
The lying flat (0°) head position for 72 hours after endovascular therapy.
|
| Experimental: The head elevation group Patients in the sitting up intervention should be nursed with their head elevated (30°) by raising the head of the bed (or using extra pillows or wedges) after undergoing endovascular therapy, and to remain in this position for 72 hours. |
Other: The The head elevation (30°) position for 72 hours
The head elevoatin (30°) position for 72 hours after endovascular therapy.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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 European Quality Five Dimensions Five Level scale (EQ-5D-5L) [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
- Symptomatic intracerebral hemorrhage incidence (Heidelberg Criteria) [within 72 hours after randomized]
evaluate intracranial hemorrhage
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinical signs consistent with acute ischemic stroke;
-
Age ≥ 18 years old;
-
Proved anterior circulation intracranial large vessel occlusion on digital subtraction angiography (ICA, M1, M2) with/without cervical lesion (tandem);
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NIHSS score ≥ 8 points before endovascular treatment;
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ASPECTS score ≤ 7 points before endovascular treatment;
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Successful vessel recanalization after endovascular treatment (defined as an eTICI score of 2b, 2c, or 3) ；
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The time from onset to randomization ≤ 24 hours (the onset time is defined as the last normal time);
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Written informed consent is obtained from patients and/or their legal representatives.
Exclusion Criteria:
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Pre-stroke mRS score>1 point;
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Patients with occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation);
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Currently in pregnant or lactating or serum beta HCG test is positive on admission;
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Immediate after endovascular treatment, CT indicates brain hemorrhage with significant mass effect;
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Contraindications to a flat head position;
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Any terminal illness with life expectancy less than 6 months;
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Participating in other clinical trials;
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Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
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Unlikely to be available for 90-day follow-up.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sichuan Provincial People's Hospital | Chengdu | China | ||
| 2 | Xinqiao Hospital | Chongqing | China | ||
| 3 | Ganzhou People's Hospital | Ganzhou | China | ||
| 4 | The 903rd Hospital of The Chinese People's Liberation Army | Hangzhou | China | ||
| 5 | Affiliated Hospital of Southwest Medical University | Luzhou | China | 646000 | |
| 6 | Mianyang Central Hospital | Mianyang | China | ||
| 7 | Wuhan No. 1 Hospital | Wuhan | China | ||
| 8 | Zigong Third People's Hospital | Zigong | China |
Sponsors and Collaborators
- Zhengzhou Yuan
Investigators
- Study Chair: Zhengzhou Yuan, Affiliated Hospital of Southwest Medical University
- Study Chair: Yong Jiang, Affiliated Hospital of Southwest Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SWMU202305