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Researchers from the University of Edinburgh lead the large-scale Eurotherm3235 Trial, which found that although hypothermia worked well in reducing pressure, it actually contributed to worse disability and more deaths six months later. The findings were significant enough that investigators halted the study early for safety reasons.
A cool head may not improve functional outcomes following traumatic brain injury.
Hypothermia therapy, which involves cooling the patient to 2 to 5 degrees below normal, is a treatment commonly used in some intensive care units to reduce swelling on the brain as a result of injury. However, its long-term effects have not been well studied.
Researchers from the University of Edinburgh lead the large-scale Eurotherm3235 Trial, which found that although hypothermia worked well in reducing pressure, it actually contributed to worse disability and more deaths six months later. The findings were significant enough that investigators halted the study early for safety reasons.
“This well conducted trial has shown that hypothermia can successfully reduce brain pressure following trauma, but after 6 months functional recovery was significantly worse than standard care alone,” Peter Andrews, MD, MB, ChB, Head of Critical Care Medicine at the University of Edinburgh, said in a release.
The trial involved 387 patients with closed brain injuries at 47 centers in 18 countries. All had intracranial pressure greater than 20 mm Hg despite stage 1 treatments of ventilation and sedation. Patients in the control group underwent stage 2 treatments that included osmotherapy. Those in the experimental group underwent hypothermia treatment first. If it didn’t bring down swelling, they then had other stage 2 treatments. If nothing worked, patients in both groups went on to stage 3 treatments (barbiturates and removal of a part of the skull). They reassessed the surviving patients six months later.
“The results of the Eurotherm3235 Trial … may lead to the demise of yet another pillar of therapy for intracranial hypertension,” Claudia S. Robertson, M.D. of Baylor in Houston and Allan H. Hopper, M.D., of Brigham and Women’s Hospital in Boston in an accompanying editorial.
Robertson and Hopper went on to suggest “This is not an excuse to allow elevated intracranial press to go unchecked, but it is an admonition to be discerning in the use of medical and surgical treatment, especially hyperthermia.”
The study was published online on October 7 in the New England Journal of Medicine. The team also presented their findings at the European Society of Intensive Care Medicine Annual Congress in Berlin on Oct 7 and at the Neurocritical Care Society annual meeting in Scottsdale, AZ, on Oct 8.