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| Name | Class |
|---|---|
| Zhujiang Hospital | OTHER |
| Clinical Research Institute, Shanghai Jiao Tong University School of Medicine | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-term Drainage | Experimental | The drainage catheter is indwelling continuously and keeps to drainage for 7 days. |
|
| Short-term Drainage | Active Comparator | The drainage catheter is indwelling continuously and keeps to drainage for 2 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month after drainage catheter removal. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of related complications. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiyao Jiang, Dr. | Contact | +8813901992806 | jiyaojiang@126.com | |
| Junfeng Feng, Dr. | Contact | +8613611860825 | fengjfmail@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiyao Jiang, Dr. | Renji Hospital, School of Medicine, Shanghai Jiao Tong University. | Study Chair |
| Junfeng Feng, Dr. | Renji Hospital, School of Medicine, Shanghai Jiao Tong University. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 201114 | China |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D013353 | Subdural Effusion |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
|
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. | Length of stay in hospital and detailed economic evaluation. | 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:
| 1, 3 and 6 months after drainage catheter removal. |
| Qinghua Wang, Dr. | Southern Medical University, China | Study Director |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020819 | Perimeningeal Infections |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |