About this trial
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°).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- HEAD DOWN TILT -10° to -15°
Treatment groups
Sponsors and collaborators
University of Milano Bicocca
Lead sponsor
Fondazione IRCCS San Gerardo dei Tintori
Collaborator
Azienda Ospedaliero-Universitaria Careggi
Collaborator
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Collaborator
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
Collaborator
Università degli Studi dell'Aquila
Collaborator
Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma
Collaborator