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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed-time drainage | Active Comparator | Drainage will be removed after 48 hours. |
|
| Exhaustive drainage | Experimental | Drainage will be removed when postoperative hematoma volume is minimized with repeated urokinase injection into hematoma cavity through catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Operation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of re-operations of chronic subdural hematoma | Rate of re-operations between fixed-time drainage group and exhaustive drainage group | From operation up to 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, and at 1, 3, and 6 months after operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weiming Liu, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100015 | China | ||
| Beijing Chaoyang Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33329333 | Background | Ou Y, Yu X, Liu X, Jing Q, Liu B, Liu W. A Comparative Study of Chronic Subdural Hematoma in Patients With and Without Head Trauma: A Retrospective Cross Sectional Study. Front Neurol. 2020 Nov 27;11:588242. doi: 10.3389/fneur.2020.588242. eCollection 2020. | |
| 30902781 | Background | Ou Y, Dong J, Wu L, Xu L, Wang L, Liu B, Li J, Liu W. An Exhaustive Drainage Strategy in Burr-hole Craniostomy for Chronic Subdural Hematoma. World Neurosurg. 2019 Jun;126:e1412-e1420. doi: 10.1016/j.wneu.2019.03.111. Epub 2019 Mar 19. |
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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.
|
| Fixed-time drainage | Procedure | 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. |
|
| Exhaustive drainage | Procedure | 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. |
|
| Postoperative computed tomography | Procedure | 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. |
|
| 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. |
| 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'. | 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 | 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 | From operation up to 6 months postoperatively |
| Beijing |
| Beijing Municipality |
| 100020 |
| China |
| Beijing Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100070 | China |
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100730 | China |
| Beijing Luhe Hospital, Capital Medical University | Beijing | Beijing Municipality | 101100 | China |
| Wangjing Hospital, China Academy of Chinese Medical Sciences | Beijing | Beijing Municipality | China |
| Puning People's Hospital | Puning | Guangdong | 515300 | China |
| Wei County Hospital of Traditional Chinese Medicine | Handan | Hebei | 056800 | China |
| Hengshui People's Hospital | Hengshui | Hebei | 053000 | China |
| First Hospital of Qinhuangdao | Qinhuangdao | Hebei | 066000 | China |
| North China University of Science and Technology Affiliated Hospital | Tangshan | Hebei | 063000 | China |
| Xiahuayuan District Hospital | Zhangjiakou | Hebei | 075000 | China |
| First People's Hospital of Lianyungang | Lianyungang | Jiangsu | 222061 | China |
| Yancheng Third People's Hospital | Yancheng | Jiangsu | 224001 | China |
| People's Hospital of Ningxia Hui Autonomous Region | Yinchuan | Ningxia | 750002 | China |
| Tianjin Huanhu Hospital | Tianjin | Tianjin Municipality | 300350 | China |
| 30797913 | Background | Ou Y, Dong J, Wu L, Xu L, Wang L, Liu B, Li J, Liu W. The Clinical Characteristics, Treatment, and Outcomes of Chronic Subdural Hematoma in Young Patients. World Neurosurg. 2019 May;125:e1241-e1246. doi: 10.1016/j.wneu.2019.02.017. Epub 2019 Feb 22. |
| 30716602 | Background | Ou Y, Dong J, Wu L, Xu L, Wang L, Liu B, Li J, Liu W. A comparative study of chronic subdural hematoma in three age ranges: Below 40 years, 41-79 years, and 80 years and older. Clin Neurol Neurosurg. 2019 Mar;178:63-69. doi: 10.1016/j.clineuro.2019.01.018. Epub 2019 Jan 29. |
| 24995782 | Background | Liu W, Bakker NA, Groen RJ. Chronic subdural hematoma: a systematic review and meta-analysis of surgical procedures. J Neurosurg. 2014 Sep;121(3):665-73. doi: 10.3171/2014.5.JNS132715. Epub 2014 Jul 4. |
| 31518980 | Background | Wu L, Ou Y, Liu W. Letter to the Editor. Benefit of postoperative computed tomography in chronic subdural hematoma. J Neurosurg. 2019 Sep 13;131(6):1992-1993. doi: 10.3171/2019.5.JNS191212. Print 2019 Dec 1. No abstract available. |
| 36941714 | Derived | Wu L, Ou Y, Zhu B, Guo X, Yu X, Xu L, Li J, Feng E, Li H, Wang X, Chen H, Sun Z, Liu Z, Yang D, Zhang H, Liu Z, Tang J, Zhao S, Zhang G, Yao J, Ma D, Sun Z, Zhou H, Liu B, Liu W; ECHO Trial Collaborators. Exhaustive drainage versus fixed-time drainage for chronic subdural hematoma after one-burr hole craniostomy (ECHO): study protocol for a multicenter randomized controlled trial. Trials. 2023 Mar 20;24(1):207. doi: 10.1186/s13063-023-07250-y. |
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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