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

Status:	Active, not recruiting
Conditions:	Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	22 - 65
Updated:	1/19/2019
Start Date:	February 2014
End Date:	November 2020

HypOthermia for Patients Requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial

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.

Inclusion Criteria:

1. Non-penetrating traumatic brain injury

2. GCS motor score ≤5 (not following commands)

3. Estimated or known age 22-65 years

4. Acute subdural hematoma requiring emergent craniotomy within 6 hours of initial injury

5. Estimated time of injury to time to reach temp of 35°C<6 hrs

Exclusion Criteria:

1. Total GCS = 3 and bilateral fixed and dilated pupils

2. Following commands after an initial period of coma (GSC motor score of 6)

3. Known pre-existing neurological deficit (e.g., previous TBI, stroke)

4. Concomitant spinal cord injury

5. Arrival temperature is <35°C

6. Hemodynamic instability (i.e., MAP<60mmHg for 30 minutes)

7. Active cardiac dysrhythmia resulting in hemodynamic instability

8. Pregnancy

9. Duret hemorrhage

10. Prisoner or Ward of the State

11. Known history of clotting disorder (e.g., heparin induced thrombocytopenia, PE/DVT)

12. Injury to other body organ where hypothermia would be precluded because of bleed-ing
risk (e.g., grade 3 liver laceration; bowel laceration; flail lung or INR>1.4)

13. Inability to obtain informed consent or utilize exception to informed consent for
emergency research.

We found this trial at

sites

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania 15213

Principal Investigator: David O Okonkwo, MD,PhD

from

Pittsburgh, PA