Head-Down Tilt Positioning Tested in Acute Stroke Patients Before Thrombectomy
Tests head-down tilt positioning in adults with acute ischemic stroke before thrombectomy.
Plain-language title generated from the registry record
Registry title: Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke
Key facts
- Where
- Avezzano, Florence, Messina, Monza, Roma, and Udine, ItalySee the 6 sites
- Phase
- Phase 2
Where in Italy
- Ospedale Civile SS. Nicola e Filippo Avezzano Pronto SoccorsoAvezzano, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyNot yet recruiting
- Azienda Ospedaliera Policlinico Universitario "G. Martino"Messina, ItalyNot yet recruiting
- Fondazione IRCCS San Gerardo dei Tintori - MonzaMonza, ItalyTaking people
- Azienda Ospedaliero Universitaria Policlinico Umberto IRoma, ItalyNot yet recruiting
- Ospedale Santa Maria della MisericordiaUdine, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Milano Bicocca
- Trial code
- NCT06297863
- Record updated
- 6 May 2026
- Original description
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.Read full original descriptionShow less
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
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°).
Inclusion: 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: 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); Vomiting upon stroke onset; History of glaucoma; History or imaging findings of intracranial hypertension of any aetiology; Impaired consciousness, defined as NIHSS score of 2 or 3 of the item 1a (level of consciousness): not alert, requires repeated stimulation or unresponsive; 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.