Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178711
Status:
TERMINATED
Last Update Posted:
2014-09-17
First Post:
2005-09-13
Brief Title:
Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
National Acute Brain Injury Study Hypothermia IIR
Status:
TERMINATED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NABISHIIR
Brief Summary:
Induction of hypothermia to 35C by 25 hours after severe traumatic brain injury reaching 33C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months after injury compared to patients randomized to normothermia
Detailed Description:
NABISHIIR was a randomized clinical trial conducted in patients with severe brain injury age 16-45 Patients were randomized to standard treatment at normothermia or to standard treatment with moderate hypothermia 325-34C for 48 hours An intent to treat analysis was used with the primary outcome measure as the Glasgow Outcome Scale at six months after injury GOS is dichotomized into good outcome Good RecoveryModerate Disability and poor outcome Severe Disability Vegetative Dead
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FDA-2014-109 | OTHER | FDA | None |