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NOT YET RECRUITING
NCT06391203
NA

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

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2024-06-01

Completion Date

2027-12-31

Last Updated

2024-05-06

Healthy Volunteers

No

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.

Locations (1)

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

Shanghai, Shanghai Municipality, China