Clinical trial NCT06391203: Study on the Efficacy of Long-term Drainage of Subdural Effusion After Decompressive Craniectomy
Official title: A Randomised Controlled Trial to Evaluate Long-term Drainage for Patients Undergoing Decompressive Craniectomy With the Complication of Subdural Diffusion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Decompressive Craniectomy
Subdural Effusion
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Zhujiang Hospital
name: Clinical Research Institute, Shanghai Jiao Tong University School of Medicine
First posted: 2024-04-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Unilateral DC surgery was performed on TBI patients after injury;
2. Subdural effusion occurred for the first time and occurred within 30 days after DC surgery;
3. Unilateral effusion accumulation (can appear on the same or opposite side of the bone flap);
4. The subdural effusion cannot be absorbed or has no decreasing trend with conservative treatment and consistent with the indications for surgical treatment;
5. Sign the study informed consent;

Exclusion Criteria:

1. History of craniocerebral disease or craniocerebral surgery;
2. Patients with intracranial infection (cerebrospinal fluid test results must be confirmed by lumbar puncture before inclusion);
3. Combined with ventricular hydrocephalus;
4. Other factors lead to poor prognosis or affect the treatment plan of the patient, even if the effusion can be recovered well, but severe pre-existing disability or severe co-morbidity such as serious heart disease leads to poor prognosis or even death;
5. Pregnant female.

Primary outcomes:
measure: Recurrence rate of subdural effusion 1 month after drainage catheter removal.
timeFrame: 1 month after drainage catheter removal.
Secondary outcomes:
measure: Incidence of related complications.
timeFrame: 1 month after drainage catheter removal.
measure: Method of re-intervention after recurrence of effusion.
timeFrame: 1 month after drainage catheter removal.
measure: Length of stay in hospital and detailed economic evaluation.
timeFrame: 1 month after drainage catheter removal.
measure: GOSE (extended Glasgow Outcome Scale) scores.
timeFrame: 1, 3 and 6 months after drainage catheter removal.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital,School of Medicine,Shanghai Jiao Tong University
name: Jiyao Jiang, Dr.
role: STUDY_CHAIR
affiliation: Renji Hospital,School of Medicine,Shanghai Jiao Tong University
name: Junfeng Feng, Dr.
role: STUDY_DIRECTOR
affiliation: Southern Medical University, China
name: Qinghua Wang, Dr.
role: STUDY_DIRECTOR
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