CompletedNot Applicable

Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury

China312 participantsStarted 2013-11-12

Plain-language summary

This study is a prospective multi-centre randomized trial to compare the effect of long-term mild hypothermia versus routine normothermic intensive management in patients with severe traumatic brain injury. The primary hypothesis is that the induction of mild hypothermia (maintained at 34-35℃) for 5 days will improve the outcome of patients at six months post injury compared with normothermia.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 - 65 years within 6 hours post injury; * Closed head injury; * Glasgow Coma Scale(GCS) score 4 to 8 after resuscitation; * The intracranial pressure is more than 25 mmHg; * Cerebral contusion on computed tomographic scan. Exclusion Criteria: * GCS of 3 with bilateral fixed and dilated pupils; * A life-threatening injury to an organ other than the brain; * No spontaneous breathing or cardiac arrest at the scene of the injury; * No consent; * Pregnancy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neurological function

Timeframe: 6 months post injury

Trial details

NCT IDNCT01886222

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-30

View on ClinicalTrials.gov More Brain Injuries trials