Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-25
Brief Title:
Study on the Efficacy of Long-term Drainage of Subdural Effusion After Decompressive Craniectomy
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
A Randomised Controlled Trial to Evaluate Long-term Drainage for Patients Undergoing Decompressive Craniectomy With the Complication of Subdural Diffusion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Drilling or puncture drainage is commonly used in TBI patients with subdural effusion following decompressive craniectomy who fail to respond to conservative treatment but there is no exact regulation or guideline recommendation for the drainage time The investigators aimed to conduct a randomized controlled trial to evaluate the efficacy and safety of long-term versus short-term drainage in the treatment of subdural effusion after decompressive craniectomy in patients with traumatic brain injury
Detailed Description:
Subdural effusion is a common complication following decompressive craniectomy for TBI traumatic brain injury with an overall incidence of 20-50 The clinical symptoms of subdural effusion are mainly related to the volume of effusion and patients with a small volume of effusion may have no obvious symptoms The flap bulge and tension of the decompression window can be seen on the same side of the decompressive craniectomy window The specific clinical manifestations can include headache dizziness vomiting epilepsy hemiplegia disturbance of consciousness and other related symptoms The degree of disturbance of consciousness changes which can seriously affect the prognosis of patients Drilling or puncture drainage is often used in patients with subdural effusion who fail to treat conservatively but the drainage time has not been defined or recommended by guidelines At present short-term drainage is the main treatment but there are problems such as difficulty completely absorbing the effusion or repeated recurrence Long-term drainage can improve the absorption rate of effusion but there is a risk of intracranial infection and other complications Therefore it is rarely used in clinical practice and its clinical risks and benefits are not yet clear Therefore the investigators aimed to conduct a randomized controlled trial to evaluate the efficacy and safety of long-term drainage and short-term drainage in the treatment of subdural effusion after decompressive craniectomy in patients with traumatic brain injury
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None