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

May 2, 2024 updated by: RenJi Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201114
        • Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Long-term Drainage
The drainage catheter is indwelling continuously and keeps to drainage for 7 days.
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.
Active Comparator: Short-term Drainage
The drainage catheter is indwelling continuously and keeps to drainage for 2 days.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 month after drainage catheter removal.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 month after drainage catheter removal.
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).
1 month after drainage catheter removal.
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.
1 month after drainage catheter removal.
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:

  1. death;
  2. persistent vegetative state;
  3. lower severe disability;
  4. upper severe disability (stratum 3 and 4 were considered as severe disability, with permanent requirement for help with daily living);
  5. lower moderate disability;
  6. 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);
  7. lower good recovery;
  8. upper good recovery (stratum 7 and 8 were considered as good recovery).
1, 3 and 6 months after drainage catheter removal.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhujiang Hospital
Clinical Research Institute, Shanghai Jiao Tong University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jiyao Jiang, Dr., Renji Hospital,School of Medicine,Shanghai Jiao Tong University
  • Study Director: Junfeng Feng, Dr., Renji Hospital,School of Medicine,Shanghai Jiao Tong University
  • Study Director: Qinghua Wang, Dr., Southern Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DRAINAGE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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