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

A Randomised Controlled Trial to Evaluate Long-term Drainage for Patients Undergoing Decompressive Craniectomy With the Complication of Subdural Diffusion

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury; Subdural Effusion; Decompressive Craniectomy
• Intervention / Treatment: Procedure: Long-term Drainage; Procedure: Short-term Drainage

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiyao Jiang, Dr.; Phone Number: +8813901992806; Email: jiyaojiang@126.com
• Study Contact Backup: Name: Junfeng Feng, Dr.; Phone Number: +8613611860825; Email: fengjfmail@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201114
      • Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Long-term Drainage; The drainage catheter is indwelling continuously and keeps to drainage for 7 days.	Procedure: 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.
Active Comparator: Short-term Drainage; The drainage catheter is indwelling continuously and keeps to drainage for 2 days.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate of subdural effusion 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.	1 month after drainage catheter removal.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of related complications.	Incidence of related complications (such as intracranial infection and hemorrhage) within 1 month after drainage tube removal.	1 month after drainage catheter removal.
Method of re-intervention after recurrence of effusion.	Method of re-intervention after recurrence of effusion (conservative treatment or invasive treatment, specific method).	1 month after drainage catheter removal.
Length of stay in hospital and detailed economic evaluation.	Length of stay in hospital and detailed economic evaluation.	1 month after drainage catheter removal.
GOSE (extended Glasgow Outcome Scale) scores.	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: death;; persistent vegetative state;; lower severe disability;; upper severe disability (stratum 3 and 4 were considered as severe disability, with permanent requirement for help with daily living);; lower moderate disability;; upper moderate disability (stratum 5 and 6 were considered as mild disability, without a need for assistance in everyday life, that might, however, require special equipment for employment);; lower good recovery;; upper good recovery (stratum 7 and 8 were considered as good recovery).	1, 3 and 6 months after drainage catheter removal.

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Zhujiang Hospital; Clinical Research Institute, Shanghai Jiao Tong University School of Medicine
• Investigators: Study Chair: Jiyao Jiang, Dr., Renji Hospital,School of Medicine,Shanghai Jiao Tong University; Study Director: Junfeng Feng, Dr., Renji Hospital,School of Medicine,Shanghai Jiao Tong University; Study Director: Qinghua Wang, Dr., Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Wounds and Injuries; Central Nervous System Infections; Craniocerebral Trauma; Trauma, Nervous System; Perimeningeal Infections; Brain Injuries; Brain Injuries, Traumatic; Subdural Effusion
• Other Study ID Numbers: DRAINAGE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No