An interventional study of Operation and Fixed-time drainage in Hematoma, Subdural, Chronic, sponsored by Beijing Tiantan Hospital. Completed at 17 sites in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
A prospective, multicenter, randomized controlled trial is designed to compare the recurrence rates and clinical outcomes in patients with chronic subdural hematoma using exhaustive drainage or fixed-time drainage after one-burr hole craniostomy.
Chronic subdural hematomas (CSDHs) are one of the most common neurosurgical conditions. The goal of surgery is to alleviate symptoms and minimize the risk of symptomatic recurrences. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural closed-system drainage. The drainage is removed after 48 hours, which can be described as fixed-time drainage strategy. According to literature, the recurrence rate is 5-33% with this strategy. In the investigators' retrospective study, postoperative hematoma volume (p=0.001, B=0.028, Exp(B)=1.028, 95% CI 1.011-1.046) was found to significantly increase the risk of recurrence. Based on these results, an exhaustive drainage strategy may minimize postoperative hematoma volume and achieve a low recurrence rate and good outcomes. This is a prospective, multicenter, randomized controlled trial designed to include 304 participants over the age of 18 years presenting with a symptomatic CSDH verified on cranial computed tomography or magnetic resonance imaging. After informed consent is obtained, participants are randomly allocated to an exhaustive drainage or fixed-time drainage group. The primary endpoint is recurrence indicating a reoperation within 6 months. Secondary outcomes include modified Rankin Scale, Markwalder Grading Scale, European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L), rate of complications, rate of adverse events and effect on comorbidity.
116 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's enrollment of 309 is above the median of 170 across 89 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Beijing Tiantan Hospital is the lead sponsor of 483 studies on the registry; 289 are open to participants now.
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Exclusion Criteria:
Drainage will be removed after 48 hours.
Procedure: Operation · Procedure: Fixed-time drainage · Procedure: Postoperative computed tomography
Drainage will be removed when postoperative hematoma volume is minimized with repeated urokinase injection into hematoma cavity through catheter.
Procedure: Operation · Procedure: Exhaustive drainage · Procedure: Postoperative computed tomography
All participants are treated with burr-hole craniotomy and a drainage system as follows. Participants undergo surgical procedure under local anesthesia in the hemisphere with a lateral position, but general anesthesia is performed when participant cannot tolerate the operation. A single 1.5 cm burr hole is drilled over the maximum width of the hematoma cavity. After coagulating with bipolar diathermy, dura mater is opened with a cruciate incision. A soft catheter is placed carefully in all directions of the hematoma cavity for irrigating subdural collections with 1,000 mL warm Ringer's lactate saline until clarification. The drainage catheter is inserted ½ length of the maximum diameter of the hematoma cavity toward the frontal region. After the skin is closed, the catheter was connected to a soft collection bag that is placed under the head for passive drainage. During the drainage period, participants stay in bed until the drain is removed.
All participants will be treated with a one-burr-hole craniotomy with irrigation and a closed drainage system. The drainage will be removed after 48 hours.
All participants will be treated with a one-burr-hole craniotomy with irrigation and a closed drainage system. If the computed tomography (CT) scan on the first day after surgery indicates that the affected brain region shows sufficient re-expansion, the drainage catheter will be removed when drainage ceases. If subdural collections remain in the hematoma cavity, the participant will be treated with 30,000 U urokinase injection into the hematoma cavity through the catheter. The catheter will be closed and reopened in 1.5-2 hours, and a CT scan will be performed when drainage ceases. If the CT scan shows sufficient re-expansion of the brain, the catheter will be removed. However, if the brain does not show good re-expansion and there is still a residual subdural collection, the above steps will be repeated. If the participant is subjected to urokinase injection for 3 times, the catheter will be removed when drainage ceases.
All participants undergo a CT scan before the drain is removed, and the last CT scan will be performed before the patient is discharged from the hospital.
Rate of re-operations of chronic subdural hematoma
Rate of re-operations between fixed-time drainage group and exhaustive drainage group
Time frame: From operation up to 6 months postoperatively
Change of Modified Rankin Scale (MRS) between groups from baseline to 6 months after operation
Modified Rankin Scale ranges from score 1 to 6, and higher scores mean a worse clinical outcome, where score 1 indicates normal daily functionality and score 6 indicates death.
Time frame: At baseline, and at 1, 3, and 6 months after operation
Change of Markwalder Grading Scale (MGS) between groups from baseline to 6 months after operation
Markwalder Grading Scale ranges from grade 0 to 4, and higher scores mean a worse neurological outcome, where grade 0 indicates normal neurological function and grade 4 indicates coma.
Time frame: At baseline, and at 1, 3, and 6 months after operation
Change of health related quality of life between groups from baseline to 6 months after operation
A standardized instrument, EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire, will be used as a generic measure of health related quality of life. The questionnaire contains 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension rates across five levels, including 'No problems-Slight problems-Moderate problems-Severe problems-Unable to'.
Time frame: At baseline, and at 1, 3, and 6 months after operation
Rate of mortality between groups within 6 months
Rate of mortality between fixed-time drainage group and exhaustive drainage group
Time frame: From operation up to 6 months postoperatively
Rate of complications and adverse events between groups within 6 months
Rate of complications and adverse events between fixed-time drainage group and exhaustive drainage group within 6 months
Time frame: From operation up to 6 months postoperatively
Plan to share: No
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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