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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
The University off Miami and Ryder Trauma Center, Jackson Memorial Hospital
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Cincinnati
Cincinnati, Ohio, United States
The University of Pittsburgh Medical Center and UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
The University of Texas at Houston Medical School and Memorial Hermann Hospital
Houston, Texas, United States
Kurume University Hospital
Fukuoka, Japan
Saiseikai Fukuoka General Hospital
Fukuoka, Japan
Kagawa University Hospital
Kagawa, Japan
Nagasaki University Hospital
Nagasaki, Japan
Osaka Mishima Emergency Critical Care Center
Osaka, Japan
...and 4 more locations
Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury
Participants were monitored for 6 months after injury, and GOS-E was scored as favorable (moderate disability to good recovery) or unfavorable (severe disability, vegetative state, or death) at 6 months post-injury.
Time frame: 6 months post injury
Safety as Assessed by Number of Adverse Events Reported Per Participant
Adverse events were graded according to the USDHHS Common Terminology Criteria for Adverse Events V4.0. Serious adverse events and pre-defined adverse events of interest that historically were known to be of concern with hypothermia treatment were selected to be monitored and reported regardless of grade. These included cardiac arrhythmias, thromboembolic events, pneumonia, bleeding or hemorrhage, intraoperative hemorrhage, infection (culture positive, e.g., blood stream infection, urinary tract infection, ventriculitis), device-related infection, and death. The number of adverse events per participant were compared between groups.
Time frame: 6 months post injury
Intensive Care Unit (ICU) Length of Stay
Time frame: from ICU admission to ICU discharge (median of about 11 to 13 days)
Hospital Length of Stay
Time frame: from hospital admission to hospital discharge (median of about 18 to 21 days)
Incidence of Cortical Spreading Depolarization
Time frame: 6 months
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