HypOthermia for Patients Requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Subdural Hematoma, Traumatic
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 32
- Locations
- 14
- Primary Endpoint
- Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Dong Kim
Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury
Time Frame: 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 Outcomes
- Safety as Assessed by Number of Adverse Events Reported Per Participant(6 months post injury)
- 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)