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

NCT06391203 | Not Yet Recruiting DMC

• 1 other identifier: DRAINAGE
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Decompressive Craniectomy; Subdural Effusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of related complications.

  1 month after drainage catheter removal.

• Method of re-intervention after recurrence of effusion.

  1 month after drainage catheter removal.

• Length of stay in hospital and detailed economic evaluation.

  1 month after drainage catheter removal.

• GOSE (extended Glasgow Outcome Scale) scores.

  1, 3 and 6 months after drainage catheter removal.

Study Arms (2)

Long-term Drainage

EXPERIMENTAL

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

Procedure: Long-term Drainage

Short-term Drainage

ACTIVE COMPARATOR

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

Procedure: Short-term Drainage

Interventions

Long-term Drainage 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.

Long-term Drainage

Short-term Drainage 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.

Short-term Drainage

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of craniocerebral disease or craniocerebral surgery;
• Combined with ventricular hydrocephalus;
• 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;
• Pregnant female.

Sponsors & Collaborators

• RenJi Hospital: lead
• Zhujiang Hospital: collaborator
• Clinical Research Institute, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

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

Shanghai, Shanghai Municipality, 201114, China

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Subdural Effusion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Perimeningeal Infections; Central Nervous System Infections; Infections

Study Officials

• Jiyao Jiang, Dr.

  Renji Hospital,School of Medicine,Shanghai Jiao Tong University

  STUDY CHAIR

• Junfeng Feng, Dr.

  Renji Hospital,School of Medicine,Shanghai Jiao Tong University

  STUDY DIRECTOR

• Qinghua Wang, Dr.

  Southern Medical University, China

  STUDY DIRECTOR

Central Study Contacts

Jiyao Jiang, Dr.

CONTACT

+8813901992806; jiyaojiang@126.com

Junfeng Feng, Dr.

CONTACT

+8613611860825; fengjfmail@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

CN (1)