Actively Recruiting
Trial of Head Down Tilt Positioning to Improve Blood Flow in Adults with Acute Ischemic Stroke Undergoing Mechanical Thrombectomy
Led by University of Milano Bicocca · Updated on 2026-05-06
118
Participants Needed
6
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the use of head down tilt at -10 to -15 HDT15 as a possible therapy to improve collateral blood flow in adults with acute ischemic stroke caused by a blockage in the middle cerebral artery MCA. This multicenter, randomized, controlled, open-label trial with blinded outcome assessment aims to compare HDT15 positioning with the usual positioning 0 to 30 before mechanical thrombectomy, a procedure to remove the blockage. The study seeks to determine if HDT15 can enhance collateral circulation, extend the survival of brain tissue at risk, and improve outcomes from thrombectomy. The intervention group will have their head tilted downward by 10 to 15 starting in the Emergency Room and maintained during transfer to and throughout the mechanical thrombectomy procedure, using specialized equipment to ensure precise angles. The control group will receive standard care with usual positioning between 0 to 30. The HDT15 therapy is expected to last approximately 30 to 90 minutes, covering the critical period before and during thrombectomy. Participants will be closely monitored during the study for neurological changes, blood pressure, oxygen levels, and any side effects such as vomiting or pneumonia. Imaging assessments will be performed during thrombectomy to evaluate collateral blood flow. Functional outcomes will be measured up to three months after treatment. The study includes safety monitoring to track any complications and ensure patient well-being throughout the trial, which runs through the end of 2026.
CONDITIONS
Brief Title
Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke
Research Team
S
Simone Beretta, MD, PhD
B
BiCRO (academic CRO)
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