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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




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

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.