To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients

Not Applicable

Terminated

Interventions: Device: Temperature management Zoll Intravascular Temperature Management device

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Hypothermia	Temperature management Zoll Intravascular Temperature Management device	Hypothermia to 33°C
Normothermia	Temperature management Zoll Intravascular Temperature Management device	standard care - normothermia (37°C)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury	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.

Secondary Outcome Measures

Name	Time	Method
Safety as Assessed by Number of Adverse Events Reported Per Participant	6 months post injury	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.
Hospital Length of Stay	from hospital admission to hospital discharge (median of about 18 to 21 days)
Intensive Care Unit (ICU) Length of Stay	from ICU admission to ICU discharge (median of about 11 to 13 days)
Incidence of Cortical Spreading Depolarization	6 months

Locations (14): Nagasaki University Hospital
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Nagasaki, Japan
Saiseikai Fukuoka General Hospital
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Fukuoka, Japan
Nippon Medical School Tamanagayama Hospital
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Tokyo, Japan
The University of Texas at Houston Medical School and Memorial Hermann Hospital
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Houston, Texas, United States
National Disaster Medical Center
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Tokyo, Japan
Kurume University Hospital
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Fukuoka, Japan
Kagawa University Hospital
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Kagawa, Japan
Nippon Medical School Hospital
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Tokyo, Japan
Yamaguchi University Hospital
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Yamaguchi, Japan
The University off Miami and Ryder Trauma Center, Jackson Memorial Hospital
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Miami, Florida, United States
The University of Pittsburgh Medical Center and UPMC Presbyterian
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Pittsburgh, Pennsylvania, United States
University of Cincinnati
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Cincinnati, Ohio, United States
Emory University
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Atlanta, Georgia, United States
Osaka Mishima Emergency Critical Care Center
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Osaka, Japan