Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040339
Status:
COMPLETED
Last Update Posted:
2008-01-08
First Post:
2002-06-24
Brief Title:
Hypothermia to Treat Severe Brain Injury
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institute of Neurological Disorders and Stroke NINDS
Study Overview
Official Title:
The National Acute Brain Injury Study Hypothermia II NABISH II
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to determine if hypothermia body cooling administered very soon after a severe brain injury improves functional outcome This pilot trial ended in July 2005 Please see clinicaltrialsgov record number NCT00178711 for the Phase III version of the trial see link below
Detailed Description:
After brain injury the brain produces certain chemicals that are harmful to the injured tissues Moderate hypothermia-also called body cooling-may slow or prevent the production of these chemicals Hypothermia also decreases the amount of oxygen needed by the brain which may provide some protection during this critical period Earlier studies have shown that maintenance of moderate hypothermia may have a helpful effect in head injury patients ages 16 to 45 who arrive at the hospital with a low body temperature suggesting that very early cooling may be beneficial
In this study scientists will initiate hypothermia or body cooling to 35C within two hours of severe brain injury to determine if body cooling improves functional outcome
Patients may enter the study in one of two ways They may be evaluated and surface cooling begun at the scene by emergency medical services EMS personnel affiliated with the study or patients who arrive in the emergency department ED of the study hospital within 2 hours of injury-and who have not already been evaluated by EMS personnel affiliated with the study-will be evaluated and cooling begun if applicable by NABISH study personnel
NABISH-trained EMS personnel who reach a patient with a suspected severe head injury within 2 hours of injury will induce hypothermia to 35C at the scene in transit or in the ED
NABISH study personnel will induce hypothermia to 35C in the ED in patients with suspected severe head injury who reach the ED within 2 hours of injury if cooling has not already begun Patients who meet entry criteria based upon past studies for moderate hypothermia for 48 hours will then be cooled to 33C and then gradually rewarmed after 48 hours at 33C Patients initially cooled to 35C within 2 hours of injury who prove during trauma evaluation to have exclusion criteria for 48 hours of moderate hypothermia will be warmed from 35C to 37C
This pilot trial ended in July 2005 Please see clinicaltrialsgov record number NCT00178711 for the Phase III version of the trial see link below
In this study scientists will initiate hypothermia or body cooling to 35C within two hours of severe brain injury to determine if body cooling improves functional outcome
Patients may enter the study in one of two ways They may be evaluated and surface cooling begun at the scene by emergency medical services EMS personnel affiliated with the study or patients who arrive in the emergency department ED of the study hospital within 2 hours of injury-and who have not already been evaluated by EMS personnel affiliated with the study-will be evaluated and cooling begun if applicable by NABISH study personnel
NABISH-trained EMS personnel who reach a patient with a suspected severe head injury within 2 hours of injury will induce hypothermia to 35C at the scene in transit or in the ED
NABISH study personnel will induce hypothermia to 35C in the ED in patients with suspected severe head injury who reach the ED within 2 hours of injury if cooling has not already begun Patients who meet entry criteria based upon past studies for moderate hypothermia for 48 hours will then be cooled to 33C and then gradually rewarmed after 48 hours at 33C Patients initially cooled to 35C within 2 hours of injury who prove during trauma evaluation to have exclusion criteria for 48 hours of moderate hypothermia will be warmed from 35C to 37C
This pilot trial ended in July 2005 Please see clinicaltrialsgov record number NCT00178711 for the Phase III version of the trial see link below
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: