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.

Detailed Summary:
Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome: Extended Outcome Glasgow Scale [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The University of Texas Health Science Center, Houston

Dates:
Date Received: February 14, 2014
Date Started: February 2014
Date Completion: November 2020
Last Updated: December 13, 2016
Last Verified: December 2016