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

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

Interventions

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.

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.

Sponsors & Collaborators

• Zhujiang Hospital

  collaborator OTHER

• Clinical Research Institute, Shanghai Jiao Tong University School of Medicine

  collaborator UNKNOWN

• RenJi Hospital

  lead OTHER

Principal Investigators

• Jiyao Jiang, Dr. · Renji Hospital,School of Medicine,Shanghai Jiao Tong University

• Junfeng Feng, Dr. · Renji Hospital,School of Medicine,Shanghai Jiao Tong University

• Qinghua Wang, Dr. · Southern Medical University, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2026-06-01

Completion

2027-12-31

Countries

• China

Study Locations