The researchers note that the findings were consistent across all regions and sites, and were based on contemporary standards of care. Earlier studies supporting hypothermia were typically done in the 90s.

To avoid bias, the team also conducted the majority of neurological function outcome assessments face to face with the patient or relatives using assessors who were unaware of the treatment group.

The researchers also “blinded the analysis and writing processes, so in the end we had two manuscripts with the groups interchanged and all authors had to agree on both versions before breaking the randomization code,” said Dr. Nielsen. “With this method we avoided analysis and writing bias which is a real problem in scientific production.”

The authors note that “since we did not include a control group without temperature management, this trial leaves a knowledge gap regarding whether any temperature management is better than no temperature management.”

“There will be many trying to find ways around these results, for example by advocating individualized therapies etc.,” said Dr. Nielsen. “This is all very compelling but (as of) today not supported by any robust evidence. On the contrary, our findings from both this trial and our previous are that the results were consistent in subgroups. So, in summary, I think this trial will change practice.”