To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients (NCT02064959) | Clinical Trial Compass
TerminatedNot Applicable
To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients
Stopped: interim analysis revealed it was futile, we would not reach an answer at N=60.
United States, Japan32 participantsStarted 2014-03-22
Plain-language summary
This randomized, prospective trial will study the effect of very early cooling in patients undergoing surgical evacuation of acute subdural hematomas (35°C prior to opening the dura followed by maintenance at 33°C for a minimum of 48h). Intravascular cooling catheters (Thermogard XP Device, Zoll) will be utilized to induce hypothermia or to maintain normothermia.
The primary objective is to determine if rapid induction of hypothermia prior to emergent craniotomy for traumatic subdural hematoma (SDH) will improve outcome as measured by Glasgow Outcome Scale-Extended (GOSE) at 6 months.
Who can participate
Age range
22 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:
* Non-penetrating traumatic brain injury
* Glasgow Coma Scale (GCS) motor score ≤5 (not following commands)
* Estimated or known age 22-65 years
* Acute subdural hematoma requiring emergent craniotomy within 6 hours of initial injury
* Estimated time of injury to time to reach temp of 35°C\<6 hrs
Exclusion Criteria:
* Total GCS = 3 and bilateral fixed and dilated pupils
* Following commands after an initial period of coma (GSC motor score of 6)
* Known pre-existing neurological deficit (e.g., previous traumatic brain injury (TBI), stroke)
* Concomitant spinal cord injury
* Arrival temperature is \<35°C
* Hemodynamic instability (i.e., mean arterial pressure (MAP)\<60 millimetres of mercury (mmHg) for 30 minutes)
* Active cardiac dysrhythmia resulting in hemodynamic instability
* Pregnancy
* Duret hemorrhage
* Prisoner or Ward of the State
* Known history of clotting disorder (e.g., heparin induced thrombocytopenia, pulmonary embolism/deep venous thrombosis)
* Injury to other body organ where hypothermia would be precluded because of bleeding risk (e.g., grade 3 liver laceration; bowel laceration; flail lung or international normalized ratio (INR) \>1.4)
* Inability to obtain informed consent or utilize exception to informed consent for emergency research.
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
Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury
Timeframe: 6 months post injury
Trial details
NCT IDNCT02064959
SponsorThe University of Texas Health Science Center, Houston