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| Targeted temperature management after intracerebral hemorrhage (TTM-ICH): methodology of a prospective randomized clinical trial |
Targeted temperature management after intracerebral hemorrhage (TTM-ICH): methodology of a prospective randomized clinical trial
Fred Rincon, David P Friedman, Rodney Bell, Stephan A Mayer, Paul F Bray
Abstract
Rationale: Intracerebral hemorrhage causes 15% of strokes annually in the United States, and there is currently no effective therapy.
Aims and hypothesis: This is a clinical trial designed to study the safety, feasibility, and efficacy of a protocol of targeted temperature management to moderate hypothermia in intracerebral hemorrhage patients.
Methods: The targeted temperature management after intracerebral hemorrhage trial is a prospective, single-center, interventional, randomized, parallel, two-arm (1:1) phase-II clinical trial with blinded end-point ascertainment. Intracerebral hemorrhage patients will be randomized within 18 h of symptom onset to either 72 h of targeted temperature management to moderate hypothermia (32-34°C) followed by a controlled rewarming at of 0·05-0·1°C per hour or 72 h of targeted temperature management to normothermia (36-37°C) using endovascular or surface cooling.
