Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 201114, China
NCT Number: NCT06391203
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 201114, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After drilling or puncture, the drainage catheter is indwelling continuously and keeps to drainage for 7 days. Keep incision sterility, record the daily fluid drainage flow, and perform biochemical and bacterial culture identification tests for CSF regularly. Removing drainage catheter when the allocated time is reached. If there is still unabsorbed effusion after the allocated time is reached, the catheter placement time is extended and the relevant information is recorded.
After drilling or puncture, the drainage catheter is indwelling continuously and keeps to drainage for 2 days. Keep incision sterility, record the daily fluid drainage flow, and perform biochemical and bacterial culture identification tests for CSF regularly. Removing drainage catheter when the allocated time is reached. If there is still unabsorbed effusion after the allocated time is reached, the catheter placement time is extended and the relevant information is recorded.
Time frame: 1 month after drainage catheter removal.
The evaluation criteria of whether the effusion has recurred is based on the diagnostic results of the imaging examination. The specific manifestations are that the skull CT examination finds that the effusion has reappeared in the original effusion area.
Time frame: 1 month after drainage catheter removal.
Incidence of related complications (such as intracranial infection and hemorrhage) within 1 month after drainage tube removal.
Time frame: 1 month after drainage catheter removal.
Method of re-intervention after recurrence of effusion (conservative treatment or invasive treatment, specific method).
Time frame: 1 month after drainage catheter removal.
Length of stay in hospital and detailed economic evaluation.
Time frame: 1, 3 and 6 months after drainage catheter removal.
The primary outcome is indicated by the long-term functional outcomes, including overall mortality and the score on the "Extended Glasgow Outcome Scale" (GOS-E). "Extended Glasgow Outcome Scale" is the unabbreviated scale title, minimum value is 1 and maximum value is 8, which was scored as follows and higher scores mean a better outcome:
Contact information is provided by the study sponsor or research team.
Jiyao Jiang, Dr.
CONTACT
Junfeng Feng, Dr.
CONTACT
RenJi Hospital
Other
A Randomised Controlled Trial to Evaluate Long-term Drainage for Patients Undergoing Decompressive Craniectomy With the Complication of Subdural Diffusion
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