Hematoma, Subdural, Chronic
Conditions
Keywords
chronic subdural hematoma, fixed-time drainage, exhaustive drainage, drainage, craniostomy, urokinase
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREOperation
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.
PROCEDUREFixed-time drainage
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.
PROCEDUREExhaustive drainage
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.
PROCEDUREPostoperative computed tomography
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.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The design is open labeled with only the investigators for postoperative follow-up evaluation, the outcome assessors, and data analysts being blinded in all 19 centers. Before outcome assessment begins at every follow-up evaluation, the patients will be reminded not to reveal any information about their group allocation. If details of group allocation can be detected by the investigator during follow-ups, another blinded researcher will replace to evaluate outcome.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of chronic subdural hematoma * Chronic subdural hematoma verified on cranial computed tomography or magnetic resonance imaging * Written informed consent from patients or their next of kin according to the patient's cognitive status
Exclusion criteria
* No clinical symptoms correlating with chronic subdural hematoma * Lack of mass effect, less than 0.5 cm of midline structure shift, and no need surgery judged clinically by neurosurgeons * Previous surgery for chronic subdural hematoma during the past 6 months * Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before * Existing poor medication condition or severe comorbidity so that surgery cannot be tolerated or follow-up cannot be completed * Severe coagulopathy or high risk of life-threatening bleeding * Postoperative cooperation is suspected to be insufficient for follow-up for 6 months * Reproductive-age women without verified negative pregnancy testing * Participating in other research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of re-operations of chronic subdural hematoma | From operation up to 6 months postoperatively | Rate of re-operations between fixed-time drainage group and exhaustive drainage group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Modified Rankin Scale (MRS) between groups from baseline to 6 months after operation | At baseline, and at 1, 3, and 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. |
| Change of Markwalder Grading Scale (MGS) between groups from baseline to 6 months after operation | At baseline, and at 1, 3, and 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. |
| Change of health related quality of life between groups from baseline to 6 months after operation | At baseline, and at 1, 3, and 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'. |
| Rate of mortality between groups within 6 months | From operation up to 6 months postoperatively | Rate of mortality between fixed-time drainage group and exhaustive drainage group |
| Rate of complications and adverse events between groups within 6 months | From operation up to 6 months postoperatively | Rate of complications and adverse events between fixed-time drainage group and exhaustive drainage group within 6 months |
Countries
China
Outcome results
None listed