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NCT Number: NCT06391203

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, Shanghai Municipality, 201114, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • History of craniocerebral disease or craniocerebral surgery;
  • Patients with intracranial infection (cerebrospinal fluid test results must be confirmed by lumbar puncture before inclusion);
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Incidence of related complications.

    Time frame: 1 month after drainage catheter removal.

    Incidence of related complications (such as intracranial infection and hemorrhage) within 1 month after drainage tube removal.

  2. Method of re-intervention after recurrence of effusion.

    Time frame: 1 month after drainage catheter removal.

    Method of re-intervention after recurrence of effusion (conservative treatment or invasive treatment, specific method).

  3. Length of stay in hospital and detailed economic evaluation.

    Time frame: 1 month after drainage catheter removal.

    Length of stay in hospital and detailed economic evaluation.

  4. GOSE (extended Glasgow Outcome Scale) scores.

    Time frame: 1, 3 and 6 months after drainage catheter removal.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jiyao Jiang, Dr.

CONTACT

[email protected]

+8813901992806

Junfeng Feng, Dr.

CONTACT

[email protected]

+8613611860825

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 30, 2024
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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