drugset / Trial / NCT02453373
Helping Stroke Patients With ThermoSuit Cooling
Terminated
14 enrolled
Life Recovery Systems
Geisinger Clinic · collabTulane University School of Medicine · collab
Non-randomizedParallel-groupDouble-blindTreatment
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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Etomidate | Small molecule | — | — |
| Background | Magnesium Sulfate | Other / unclassified | — | Intravenous |
| Background | Propofol | Small molecule | — | — |
| Background | tPA | Unknown | — | Intravenous |