Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke (NCT06297863) | Clinical Trial Compass
RecruitingPhase 2
Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke
Italy118 participantsStarted 2025-03-01
Plain-language summary
The DOWN-SUITE study is multicenter, randomised, controlled, open-label clinical trial with blinded outcome assessment comparing collateral status in patients with acute ischemic stroke treated with an in-hospital application of head down tilt -10° to -15° (HDT15) versus usual positioning (0° to +30°) before endovascular mechanical thrombectomy.
This study will involve adult patients who are eligible for mechanical thrombectomy and who have acute ischemic stroke due to left or right middle cerebral artery occlusion (M1 segment).
The investigators hypothesise that HDT15, applied in acute ischemic stroke patients with a large vessel occlusion, will improve collateral circulation, prolong the survival of the ischemic penumbra and improve the clinical benefit from mechanical thrombectomy compared with standard of care (usual positioning 0° to +30°).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Acute ischemic stroke due to left or right MCA occlusion of the M1 segment (excluding occlusion of the internal carotid artery terminus + M1)
* Decision to treat with mechanical thrombectomy (with or without intravenous thrombolysis)
* Informed consent obtained from patient or patient's next of kin, or emergency consent procedure
Exclusion Criteria:
* Impaired consciousness, defined as NIHSS score of 2 or 3 of the item 1a (level of consciousness): not alert, requires repeated stimulation or unresponsive.
* Vomiting upon stroke onset.
* History of glaucoma.
* History or imaging findings of intracranial hypertension of any aetiology
* Major breath disorders, defined as follows:
* oxygen saturation ≤92% in room air at admission
* severe chronic obstructive pulmonary disease (COPD) treated with long-term oxygen therapy.
* severe heart failure with NYHA class 3 or 4 (breathlessness during ordinary physical activity or at rest).
* Severe obesity, defined as body mass index (BMI) \> 35.
* Patients participating in another interventional trial that would interfere with this study.
* Female patients who are pregnant