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

NCT06391203 · tracked via the Priya Life Science China tracker

Sponsor

RenJi Hospital

Phase

Not applicable

Started

2024-06-01

Last updated

2024-05-06

Condition(s) studied

Traumatic Brain InjuryDecompressive CraniectomySubdural Effusion

Investigational drug(s) / intervention(s)

Long-term DrainageShort-term Drainage

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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.

Primary outcome measure(s)

Recurrence rate of subdural effusion 1 month after drainage catheter removal. — 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.

Trial sites (1)

Facility	City	Region	Status
Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06391203 on ClinicalTrials.gov ↗ ← All trials in China