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Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke
Sponsor: University of Milano Bicocca
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°).
Official title: Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke: a Multicenter, Randomised, Proof of Concept, Phase 2a/b Trial in Patients Treated With Mechanical Thrombectomy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2025-03-01
Completion Date
2026-12-31
Last Updated
2025-03-11
Healthy Volunteers
No
Conditions
Interventions
HEAD DOWN TILT -10° to -15°
Head down tilt -10° to -15° (HDT15) is a positional therapy consisting of tilting the patient with the head -10° to -15° degrees below the rest of the body. Application of HDT15 will not delay usual care. The standard in-hospital patient pathway, including transfer from neuroimaging room to the angiography suite and the required procedural steps of MT, will allow sufficient time for the application of HDT15. HDT15 duration is expected to be at least 30 minutes (estimated time 30 to 90 minutes), from start to the assessment of the primary efficacy endpoint. The actual degree of HDT15 will be a range between -10° to -15°, depending on the angiographic system of each clinical site, but it will be maintained at -15° during the Emergency Room phase which is expected to account for \>50% of the total application time.
Locations (6)
Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso
Avezzano, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Azienda Ospedaliera Policlinico Universitario "G. Martino"
Messina, Italy
Fondazione IRCCS San Gerardo dei Tintori Monza
Monza, Italy
Azienda Ospedaliero Universitaria Policlinico Umberto I
Roma, Italy
Ospedale Santa Maria della Misericordia
Udine, Italy