Study on the Efficacy of Long-term Drainage of Subdural Effusion After Decompressive Craniectomy

NCT ID: NCT06391203

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2027-12-31

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.

Conditions

Traumatic Brain Injury; Decompressive Craniectomy; Subdural Effusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Long-term Drainage

The drainage catheter is indwelling continuously and keeps to drainage for 7 days.

Group Type: EXPERIMENTAL

Long-term Drainage

Intervention Type: PROCEDURE

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.

Short-term Drainage

The drainage catheter is indwelling continuously and keeps to drainage for 2 days.

Group Type: ACTIVE_COMPARATOR

Short-term Drainage

Intervention Type: PROCEDURE

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.

Interventions

Long-term Drainage

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.

Intervention Type: PROCEDURE

Short-term Drainage

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: collaborator

Clinical Research Institute, Shanghai Jiao Tong University School of Medicine

UNKNOWN

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiyao Jiang, Dr.

Role: STUDY_CHAIR

Renji Hospital,School of Medicine,Shanghai Jiao Tong University

Junfeng Feng, Dr.

Role: STUDY_DIRECTOR

Renji Hospital,School of Medicine,Shanghai Jiao Tong University

Qinghua Wang, Dr.

Role: STUDY_DIRECTOR

Southern Medical University, China

Locations

Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jiyao Jiang, Dr.

Role: CONTACT

jiyaojiang@126.com

+8813901992806

Junfeng Feng, Dr.

Role: CONTACT

fengjfmail@163.com

+8613611860825

Other Identifiers

DRAINAGE

Identifier Type: -

Identifier Source: org_study_id