Helping Stroke Patients With ThermoSuit Cooling

Summary

The aim of this study is to assess the feasibility of using the Life Recovery Systems ThermoSuit Device to induce therapeutic hypothermia (32-34°C) in victims of ischemic stroke. This feasibility clinical study will enroll a total of 30 patients with acute ischemic stroke at four clinical centers. Subjects will receive hypothermia plus conventional therapy (such as IV-tPA and/or neurothrombectomy therapies if indicated). Endpoints will include feasibility of cooling, adverse events, and neurological recovery in comparison with matched historical controls.

Timeline

Start

2017-01-25

Primary completion

2023-06-01

Completion

2023-06-02

Outcome

Outcome not reported

Stopped: “The study has achieved its objectives of showing feasibility, safety, and trend for improved mRS. FDA and LRS agreed that this study should be terminated, and that a new, PIVOTAL trial should be started.”

Publications

• Background Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24.
• Salerian JA, Schock RB, Schirmer CM, Sen S, Martin-Schild S, Goren O, Kupas DF, Freedman RJ, Aysenne A. Therapeutic hypothermia with rapid thin liquid convection is safe and feasible in acute ischemic stroke patients: the SISCO pilot study. Front Neurol. 2025 Nov 7;16:1611794. doi: 10.3389/fneur.2025.1611794. eCollection 2025.

Drugs

Indications