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Completed

NCT Number: NCT06115707

Head Position After Endovascular Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chongqing Banan District People's Hospital, Chongqing, Chongqing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical signs consistent with acute ischemic stroke;
  • Age ≥ 18 years old;
  • Proved anterior circulation large vessel occlusion on digital subtraction angiography (ICA, M1, M2) with/without cervical lesion (tandem);
  • NIHSS score ≥ 8 points before endovascular treatment;
  • ASPECTS score ≤ 7 points before endovascular treatment;
  • Successful vessel recanalization after endovascular treatment (defined as an eTICI score of 2b, 2c, or 3) ;
  • The time from onset to randomization ≤ 24 hours (the onset time is defined as the last normal time);
  • Written informed consent is obtained from patients and/or their legal representatives.

Exclusion criteria

  • Pre-stroke mRS score>1 point;
  • Patients with acute occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation);
  • Currently in pregnant or lactating or serum beta HCG test is positive on admission;
  • Contraindications to a flat head position;
  • Any terminal illness with life expectancy less than 6 months;
  • Participating in other clinical trials;
  • Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
  • Unlikely to be available for 90-day follow-up.

Treatment and study plan

The lying flat (0°-10°) head position for 72 hours

Other

The lying flat (0°-10°) head position for 72 hours after endovascular therapy.

The The head elevation (30°-40°) position for 72 hours

Other

The head elevoatin (30°-40°) position for 72 hours after endovascular therapy.

Primary outcomes

  1. Modified Rankin scale score (mRS)

    Time frame: 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 outcomes

  1. 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)

    Time frame: 90 days

    excellent outcome

  2. Proportion of patients functionally independent (mRS score 0 to 2) at 90 days

    Time frame: Within 90 days90 days

    functional independence

  3. Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)

    Time frame: 90 days

    ambulatory or bodily needs-capable or better

  4. Health-related quality of life, assessed with the EuroQol-visual analogue scales (EQ-VAS)

    Time frame: 90 days

    Health-related quality of life

  5. Mortality within 90 days

    Time frame: 90 days

    evaluate death rate of the two treatment groups

  6. severe adverse events

    Time frame: within 90 days

    evaluate complications and any adverse events

  7. Symptomatic intracerebral hemorrhage incidence (Heidelberg Criteria)

    Time frame: within 72 hours after randomized

    evaluate intracranial hemorrhage

  8. Any type of intracerebral hemorrhage (Heidelberg Criteria)

    Time frame: within 72 hours after randomized

    evaluate intracranial hemorrhage

  9. Brain edema

    Time frame: within 72 hours after randomized

    evaluate brain edema

  10. Malignant Brain Edema

    Time frame: within 72 hours after randomized

    evaluate brain edema

  11. Incidence of pulmonary infections

    Time frame: within 72 hours after randomized

    evaluate pulmonary infections

  12. Improvement in National Institute of Health stroke scale (NIHSS) score between baseline and 5~7d

    Time frame: at 5~7 days after randomization

    neurological changes.

Sponsors and collaborators

Lead sponsor

Zhengzhou Yuan

Other

Registry information

Official study title

Head Positioning After Endovascular Therapy for Acute Ischemic Stroke: A Randomized Controlled Trial

Acronym: HeadSOAR

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 3, 2023
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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