Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900168
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2021-04-07
Brief Title:
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Sponsor:
Tang-Du Hospital
Organization:
Tang-Du Hospital
Study Overview
Official Title:
A Multi-center Observational Cohort Study of Management of Moderate Traumatic Brain Injury With or Without Intracranial Pressure Monitoring in Patients With Moderate Traumatic Brain Injury in China
Status:
RECRUITING
Status Verified Date:
2023-07
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:
IPMMTBI
Brief Summary:
Objectives The primary focus for scientific investigation is to conduct a multi-center observational study to determine if intracranial pressure ICP monitoring to direct treatment of patients with moderate traumatic brain injury TBI improves medical practice and patient outcomes in China
Design and Outcomes This is a prospective observational cohort multi-center study with blinded evaluation of outcome It is a 2-group design Neurologic outcome is evaluated by extended Glasgow outcome scoreGOSE at 6 months
Interventions and Duration This is an observational study The decision of intracranial pressure monitoring is made by the relatives of patient Management of all patients will be consistent with protocols presently being used in the study hospitals For patients who received ICP monitoring the management will also be based specifically on the presence of intracranial hypertension Each patient will be evaluated at 6 months post injury on neurological outcomes
Sample Size and Population 832 patients with moderate traumatic brain injury will be collected on this study
Design and Outcomes This is a prospective observational cohort multi-center study with blinded evaluation of outcome It is a 2-group design Neurologic outcome is evaluated by extended Glasgow outcome scoreGOSE at 6 months
Interventions and Duration This is an observational study The decision of intracranial pressure monitoring is made by the relatives of patient Management of all patients will be consistent with protocols presently being used in the study hospitals For patients who received ICP monitoring the management will also be based specifically on the presence of intracranial hypertension Each patient will be evaluated at 6 months post injury on neurological outcomes
Sample Size and Population 832 patients with moderate traumatic brain injury will be collected on this study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None