Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134472
Status:
COMPLETED
Last Update Posted:
2012-05-11
First Post:
2005-08-23
Brief Title:
Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan
Sponsor:
Yamaguchi University Hospital
Organization:
Yamaguchi University Hospital
Study Overview
Official Title:
Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan
Status:
COMPLETED
Status Verified Date:
2012-05
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 mild hypothermia therapy for severe head trauma patients improves neurological outcome
Detailed Description:
Mild hypothermia therapy shows protective effects for damaged brains of animals and post cardiac arrest patients However Clifton et al reported that mild hypothermia has no protective effect for severe head trauma but has a risk of complications In this study all the participants must be treated with continuous monitoring of cardiac output and jugular venous oxygen saturation to get optimal physiological conditions Adequate anesthesia such as neuroleptanesthesia is essential to maintain organ function and tissue microcirculation Participants are randomly assigned to two groups of mild hypothermia 320 - 340 degree Celsius and anti-hyperthermia 355 - 370 C The body temperature must be kept for at least 72 hours Hypothermia must be induced within 6 hours after traumatic brain injury Glasgow outcome score at 6 months after injury and the total medical expenses of the two groups will be evaluated
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 |
|---|---|---|---|
| H16-HEART-01 | None | None | None |
| H15-HEART-01 | None | None | None |