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

About the trial

Sponsor

The University of Texas Health Science Center, Houston (with The Vivian L. Smith Center for Neurologic Research, Zoll Medical Corporation)

Tested

Temperature management Zoll Intravascular Temperature Management device (device)

Dates

Started 2014-03-22; completion 2019-02-07

Results posted

Yes

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.

From ClinicalTrials.gov, last updated 2020-10-19. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Zoll Circulation Inc reported $6,500 in research payments for this study in 2025 (2 payments).

Products named: Downstream Cartridge, Catheter, Therox Ds2 Console

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.