Clinical Trial of a New Rectum Cooling System on Patients of Hypoxic-ischemic Brain Damage (NCT02544542) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial of a New Rectum Cooling System on Patients of Hypoxic-ischemic Brain Damage
China70 participantsStarted 2014-01
Plain-language summary
This study will try to evaluate the effectiveness and safety of a new method for achieving mild hypothermia, i.e.,mild hypothermia therapy through rectum. Half of participants will be treated by the widely-used hyper-hypothermia blanket method, while the other half will be treated by the investigators' new method.
Who can participate
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:
* Neonatal HIE
* After cardiopulmonary resuscitation (CPR)
* Severe craniocerebral injury (GCS \< 8)
* Acute central nervous system infection and severe brain edema or lasting convulsion
* Severe cerebral edema caused by various metabolic factors
Exclusion Criteria:
* End-stage heart failure
* Uncorrected serious cardiovascular dysfunction
* Active intracranial hemorrhage not under control
* Platelet count \< 50 \* 10\^9 / L
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
1
Rate of Cooling
Timeframe: 4 hours
2
Body Temperature Fluctuations in Maintenance Phase
Timeframe: 12 hours
3
Rate of Rewarming
Timeframe: 24 to 48 hours
Trial details
NCT IDNCT02544542
SponsorChildren's Hospital of Chongqing Medical University