Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-04-17 @ 1:23 AM
Study NCT ID:
NCT02064959
Status:
TERMINATED
Last Update Posted:
2020-10-19
First Post:
2014-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
HypOthermia for Patients Requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
interim analysis revealed it was futile, we would not reach an answer at N=60.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOPES
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.
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 Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: