Traumatic Brain InjuryNCT06391203
Study on the Efficacy of Long-term Drainage of Subdural Effusion After Decompressive Craniectomy
A study testing Long-term Drainage and Short-term Drainage in people with Traumatic Brain Injury and Decompressive Craniectomy, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury, Decompressive Craniectomy, Subdural Effusion
- What is being tested?
- Long-term Drainage and Short-term Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 201114
About this study
Official title: 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.
Read the 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.
- Being tested
- Long-term Drainage, Short-term Drainage
- Medical subject headings
- Brain Injuries, Traumatic, Subdural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term DrainageProcedure or surgery
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 DrainageProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Long-term Drainage | Experimental | The drainage catheter is indwelling continuously and keeps to drainage for 7 days. Receives: Procedure: Long-term Drainage |
| Short-term Drainage | Active comparator | The drainage catheter is indwelling continuously and keeps to drainage for 2 days. Receives: Procedure: Short-term Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of subdural effusion 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.
Measured: 1 month after drainage catheter removal.
Secondary outcomes (4)
Incidence of related complications.
Incidence of related complications (such as intracranial infection and hemorrhage) within 1 month after drainage tube removal.
Measured: 1 month after drainage catheter removal.
Method of re-intervention after recurrence of effusion.
Method of re-intervention after recurrence of effusion (conservative treatment or invasive treatment, specific method).
Measured: 1 month after drainage catheter removal.
Length of stay in hospital and detailed economic evaluation.
Length of stay in hospital and detailed economic evaluation.
Measured: 1 month after drainage catheter removal.
GOSE (extended Glasgow Outcome Scale) scores.
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).
Measured: 1, 3 and 6 months after drainage catheter removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhujiang Hospital, Clinical Research Institute, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Jiyao Jiang, Dr., Study chair, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.Junfeng Feng, Dr., Study director, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.Qinghua Wang, Dr., Study director, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391203
- Sponsor's protocol ID
- DRAINAGE
- Status last verified
- May 2024
- First submitted
- 25 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Evaluate Long-term Drainage for Patients Undergoing Decompressive Craniectomy With the Complication of Subdural Diffusion
- ClinicalTrials.gov ID
- NCT06391203
- Acronym / sponsor ID
- DRAINAGE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Zhujiang Hospital, Clinical Research Institute, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-term Drainage | Experimental | Procedure: Long-term DrainageThe drainage catheter is indwelling continuously and keeps to drainage for 7 days. |
| Short-term Drainage | Active comparator | Procedure: Short-term DrainageThe drainage catheter is indwelling continuously and keeps to drainage for 2 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-term DrainageAfter 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 or surgery | Long-term Drainage |
| Short-term DrainageAfter 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. | Procedure or surgery | Short-term Drainage |
Primary outcome
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.
4 secondary outcomes
Incidence of related complications.
Time frame: 1 month after drainage catheter removal.
Method of re-intervention after recurrence of effusion.
Time frame: 1 month after drainage catheter removal.
Length of stay in hospital and detailed economic evaluation.
Time frame: 1 month after drainage catheter removal.
GOSE (extended Glasgow Outcome Scale) scores.
Time frame: 1, 3 and 6 months after drainage catheter removal.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiyao Jiang, Dr. study chair
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
Junfeng Feng, Dr. study director
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
Qinghua Wang, Dr. study director
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-term Drainage and Short-term Drainage in people with Traumatic Brain Injury and Decompressive Craniectomy, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiyao Jiang, Dr. (+8813901992806, jiyaojiang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of subdural effusion 1 month after drainage catheter removal. (time frame: 1 month after drainage catheter removal.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.