Hematoma, Subdural, ChronicECHONCT04573387
Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy
A study testing Operation, Fixed-time drainage and Exhaustive drainage in people with Hematoma, Subdural, Chronic, run by Beijing Tiantan Hospital at 17 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hematoma, Subdural, Chronic
- What is being tested?
- Operation, Fixed-time drainage and Exhaustive drainage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 17 sitesChina
- Study dates
- 29 Dec 2020to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Beijing Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, 101100
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality
Wei County Hospital of Traditional Chinese Medicine
Handan, Hebei, 056800
Hengshui People's Hospital
Hengshui, Hebei, 053000
First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222061
Puning People's Hospital
Puning, Guangdong, 515300
First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, 063000
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, 300350
Yancheng Third People's Hospital
Yancheng, Jiangsu, 224001
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750002
Xiahuayuan District Hospital
Zhangjiakou, Hebei, 075000
About this study
Official title: A Randomized Controlled Trial of Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy
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.
Read the 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.
- Conditions
- Hematoma, Subdural, Chronic
- Being tested
- Operation, Fixed-time drainage, Exhaustive drainage, Postoperative computed tomography
- Keywords
- chronic subdural hematoma, fixed-time drainage, exhaustive drainage, drainage, craniostomy, urokinase
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OperationProcedure or surgery
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.
Fixed-time drainageProcedure or surgery
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 drainageProcedure or surgery
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 tomographyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Fixed-time drainage | Active comparator | Drainage will be removed after 48 hours. Receives: Procedure: Operation; Procedure: Fixed-time drainage; Procedure: Postoperative computed tomography |
| Exhaustive drainage | Experimental | Drainage will be removed when postoperative hematoma volume is minimized with repeated urokinase injection into hematoma cavity through catheter. Receives: Procedure: Operation; Procedure: Exhaustive drainage; Procedure: Postoperative computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of re-operations of chronic subdural hematoma
Rate of re-operations between fixed-time drainage group and exhaustive drainage group
Measured: From operation up to 6 months postoperatively
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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'.
Measured: 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
Measured: 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
Measured: From operation up to 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start29 Dec 2020
- Primary completion9 Jul 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hematoma, Subdural, ChronicStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiming Liu, Beijing Tiantan Hospital
- Investigators
- Weiming Liu, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573387
- Sponsor's protocol ID
- KY 2020-094-02
- Acronym
- ECHO
- Status last verified
- Dec 2024
- First submitted
- 26 Sep 2020
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33329333Ou 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.
PubMed 30902781Ou 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.
PubMed 30797913Ou 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.
PubMed 30716602Liu 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.
PubMed 24995782Wu 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.
PubMed 31518980Wu 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.
PubMed 36941714
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy
- ClinicalTrials.gov ID
- NCT04573387
- Acronym / sponsor ID
- ECHO / KY 2020-094-02
- Conditions
- Hematoma, Subdural, Chronic
- Keywords
- chronic subdural hematoma, fixed-time drainage, exhaustive drainage, drainage, craniostomy, urokinase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 5 Oct 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed-time drainage | Active comparator | Procedure: Operation, Procedure: Fixed-time drainage, Procedure: Postoperative computed tomographyDrainage will be removed after 48 hours. |
| Exhaustive drainage | Experimental | Procedure: Operation, Procedure: Exhaustive drainage, Procedure: Postoperative computed tomographyDrainage will be removed when postoperative hematoma volume is minimized with repeated urokinase injection into hematoma cavity through catheter. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| OperationAll 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. | Procedure or surgery | Exhaustive drainage, Fixed-time drainage |
| Fixed-time drainageAll 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. | Procedure or surgery | Fixed-time drainage |
| Exhaustive drainageAll 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. | Procedure or surgery | Exhaustive drainage |
| Postoperative computed tomographyAll 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. | Procedure or surgery | Exhaustive drainage, Fixed-time drainage |
Primary outcome
Rate of re-operations of chronic subdural hematoma
Time frame: From operation up to 6 months postoperatively
Rate of re-operations between fixed-time drainage group and exhaustive drainage group
5 secondary outcomes
Change of Modified Rankin Scale (MRS) between groups from baseline to 6 months after operation
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
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
Time frame: At baseline, and at 1, 3, and 6 months after operation
Rate of mortality between groups within 6 months
Time frame: From operation up to 6 months postoperatively
Rate of complications and adverse events between groups within 6 months
Time frame: From operation up to 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Background: PubMed 33329333Ou 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.
- Background: PubMed 30902781Ou 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.
- Background: PubMed 30797913Ou 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.
- Background: PubMed 30716602Ou 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.
- Background: PubMed 24995782Liu 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.
- Background: PubMed 31518980Wu 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.
- Derived from this study: PubMed 36941714Wu 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Weiming Liu, MD principal investigator
Beijing Tiantan Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operation, Fixed-time drainage and Exhaustive drainage in people with Hematoma, Subdural, Chronic, run by Beijing Tiantan Hospital at 17 sites 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of re-operations of chronic subdural hematoma (time frame: From operation up to 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04573387, which also lists 7 linked publications.
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 30 Dec 2024.