Chronic Subdural HematomaNCT04500795
Prospective Study on the Use of Middle Meningeal Artery Embolization for Chronic Subdural Haematoma
A study testing Middle meningeal artery embolization in people with Chronic Subdural Hematoma and Subdural Hematoma, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Subdural haematoma is a common neurosurgical condition that results in different levels of neurological deficits in patients. It can be further classified into acute and chronic, which have different pathophysiology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma, Subdural Hematoma
- What is being tested?
- Middle meningeal artery embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (age 18 or above) with chronic subdural haematoma diagnosed by computed tomography and clinical presentation.
Who cannot join
- SDH with thickness of 10mm or less, lack of mass effect.
- SDH secondary to existing conditions (brain tumour, arachnoid cyst, spontaneous intracranial hypotension, previous craniotomy not due to chronic SDH)
- Patients in poor medication condition or with life expectancy less than 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Surgery, The Chinese University of Hong Kong
Hong Kong
About this study
Subdural haematoma is a common neurosurgical condition that results in different levels of neurological deficits in patients. It can be further classified into acute and chronic, which have different pathophysiology. Acute haematoma is a common result of traumatic injuries involving the tearing of the bridging veins, while chronic subdural haematoma can be both a result of traumatic injuries or recurrence following surgical management of the acute counterpart. For symptomatic patients, they are often surgically managed by haematoma drainage via burr-hole drainage and craniotomy. Recurrent bleeding following close monitor or surgical evacuation of haematoma is however very high. Recent studies approximate the recurrence rate of 2%-33.3%. Recent evidence suggests the angiogenesis of middle meningeal arteries (MMA) in response to inflammation and healing process contributes to the development of chronic subdural haematoma, and its high recurrence chance. Several studies have looked into the use of middle meningeal artery embolization to halt the bleeding of a chronic subdural haematoma, and have found promising results in terms of haematoma reduction and prevention of surgical rescues.
Read the detailed description
The primary goal of the study is to assess the safety and efficacy of middle meningeal artery embolization in treating patients presenting with subdural haematoma. Previous studies and trial in other countries have shown promising results. This study aims to serve as the pilot clinical study of the procedure in Hong Kong and setting the ground work for a future multi-centre randomised trial.
Patients presenting with subdural haematoma will be assessed clinically and radiologically. Patients' demographic information, clinical information, and past medical history will be recorded for the purpose of the study. Symptomatic patients will undergo haematoma removal either by burr-hole drainage or craniotomy. They will undergo a series of CT-scans before and after treatment to assess the characteristics of the haematoma (size, side, site, composition of the haematoma, etc). Patients will then be divided into the embolization group and the control group. Patients with residual or recurrent haematoma (higher than 10mm thickness of haematoma at any dimension) following prior surgical evacuation of haematoma will be admitted to the Embolization Group and undergo embolization of MMA. Serial CT scans will be taken at times of presentation of the residual or recurrent haematoma, 1-day, 1-week, 1-month, 3-month, and 6-month following embolization. Size of haematoma will be measured for comparison to the Control Group. Clinical examinations will be done at the same setting. For the control group, after the initial treatment of haematoma removal, they will be monitored clinically for signs of neurological deficits, presentation of symptoms. They remain in control group should they refuse entering the MMA embolization group. They will have the same clinical and radiological follow-up as the embolization group.
MMA embolization will be performed with a liquid embolization agent with local anaesthesia. Selective angiography will be performed before embolization to select MMA branch targets and detect potentially dangerous collateral vessels. If no dangerous collaterals are found, MMA branches supplying to the dura of convexity will be targeted and embolized according to findings of the selective angiography using a liquid embolization agent. If dangerous collaterals are identified, the microcatheter will be advanced more distally or the collaterals will be coiled prior to embolization. Procedure will be concluded once the flow stasis of MMA is confirmed. Embolization is considered successful if all MMA targets are embolized without procedural complications.
Patients with existing use of antiplatelet or anticoagulation medication will not undergo medication reversal for the embolization procedure.
Patients will be discharged following treatment based on the results of the post-operative assessments.
- Conditions
- Chronic Subdural Hematoma, Subdural Hematoma
- Being tested
- Middle meningeal artery embolization
- Keywords
- chronic subdural hematoma, subdural hematoma, head injury, middle meningeal artery, hemorrhage, embolization
- Medical subject headings
- Hematoma, Subdural, Chronic, Hematoma, Subdural, Craniocerebral Trauma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle meningeal artery embolizationProcedure or surgery
MMA embolization will be performed with a liquid embolization agent with local anaesthesia. Selective angiography will be performed before embolization to select MMA branch targets and detect potentially dangerous collateral vessels. If no dangerous collaterals are found, MMA branches supplying to the dura of convexity will be targeted and embolized according to findings of the selective angiography using a liquid embolization agent. If dangerous collaterals are identified, the microcatheter will be advanced more distally or the collaterals will be coiled prior to embolization. Procedure will be concluded once the flow stasis of MMA is confirmed. Embolization is considered successful if all MMA targets are embolized without procedural complications.
Patients with existing use of antiplatelet or anticoagulation medication will not undergo medication reversal for the embolization procedure.
| Study group | Role | What they receive |
|---|---|---|
| Embolization Group | Experimental | Patients with residual or recurrent haematoma (higher than 10mm thickness of haematoma at any dimension) following prior surgical evacuation of haematoma will be admitted to the Embolization Group and undergo embolization of MMA. Serial CT scans will be taken at times of presentation of the residual or recurrent haematoma, 1-day, 1-week, 1-month, 3-month, and 6-month following embolization. Size of haematoma will be measured for comparison to the Control Group. Clinical examinations will be done at the same setting. Receives: Procedure: Middle meningeal artery embolization |
| Control Group | No intervention | All symptomatic patients (headache unresponsive to analgesic or neurological deficits including focal neurological deficits, deteriorated consciousness, headache, seizures, and other signs or symptoms suggestive of SDH as the cause) will undergo haematoma evacuation either by burr-hole drainage or craniotomy. Their response to treatment, neurological status, and CT scans will be monitored. Asymptomatic patients will be monitored radiologically (CT) every 2-4 weeks. The decision for surgical evacuation of haematoma will be based on CT findings (increasing haematoma size) and presentation of symptoms or neurological deficits. They remain in the control group should they refuse embolization of MMA. The size of haematoma will be measured continuously based on CT scans taken at times of presentation, 1-day, 1-week, 1-month, 3-month, and 6-month post-op. Size of haematoma, residual or recurrent will be measured for comparison to the Embolization Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage volume change of recurrent haematoma
Primary outcome of the studies is the percentage volume change of recurrent haematoma measured by serial CT brain scans after embolization (embolization group) or haematoma removal (control group).
Measured: From date of recruitmnent until the date of first documented progression or date of death from any cause or at 6 months, whichever came first
Secondary outcomes (2)
Number of patients with treatment failure
Secondary outcome is number of patients with treatment failure. Treatment failure is defined as Patients presenting with reaccumulating or residual haematoma (haematoma thickness >10mm) following embolization or haematoma removal by the sixth month of follow-up; or patients requiring surgical rescue due to the recurrence of haematoma or surgical or endovascular complications.
Measured: From date of recruitment until the date of first documented progression or date of death from any cause or at 6 months, whichever came first
Number of patients with 30-day morbidities and mortality
Number of patients with 30-day morbidities and mortality. 30-day morbidities include adverse events of different severity. Severe adverse events (excluding death) include prolonged intubation longer than 48 hours, return to OR, unplanned reintubation, deep vein thrombosis or pulmonary embolism, coma, sepsis or septic shock, stroke, myocardial infarction, surgical site or deep infection, acute renal failure. Minor adverse events include urinary tract infection, pneumonia, progressive renal insufficiency, and neurological deficits (residual or new).
Measured: 30 days following the day of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Jan 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Why it stopped: Update in other trial results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients divided into two groups, embolization group and control (conventional) group. Patients remain in control group if they refuse embolization.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George KC Wong, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500795
- Sponsor's protocol ID
- GWMMAE01
- Status last verified
- Feb 2024
- First submitted
- 4 Aug 2020
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Use of Middle Meningeal Artery Embolization for Chronic Subdural Haematoma
- ClinicalTrials.gov ID
- NCT04500795
- Acronym / sponsor ID
- GWMMAE01
- Conditions
- Chronic Subdural Hematoma, Subdural Hematoma
- Keywords
- chronic subdural hematoma, subdural hematoma, head injury, middle meningeal artery, hemorrhage, embolization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Update in other trial results
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Aug 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.
Subdural haematoma is a common neurosurgical condition that results in different levels of neurological deficits in patients. It can be further classified into acute and chronic, which have different pathophysiology. Acute haematoma is a common result of traumatic injuries involving the tearing of the bridging veins, while chronic subdural haematoma can be both a result of traumatic injuries or recurrence following surgical management of the acute counterpart. For symptomatic patients, they are often surgically managed by haematoma drainage via burr-hole drainage and craniotomy. Recurrent bleeding following close monitor or surgical evacuation of haematoma is however very high. Recent studies approximate the recurrence rate of 2%-33.3%. Recent evidence suggests the angiogenesis of middle meningeal arteries (MMA) in response to inflammation and healing process contributes to the development of chronic subdural haematoma, and its high recurrence chance. Several studies have looked into the use of middle meningeal artery embolization to halt the bleeding of a chronic subdural haematoma, and have found promising results in terms of haematoma reduction and prevention of surgical rescues.
Detailed description
The primary goal of the study is to assess the safety and efficacy of middle meningeal artery embolization in treating patients presenting with subdural haematoma. Previous studies and trial in other countries have shown promising results. This study aims to serve as the pilot clinical study of the procedure in Hong Kong and setting the ground work for a future multi-centre randomised trial.
Patients presenting with subdural haematoma will be assessed clinically and radiologically. Patients' demographic information, clinical information, and past medical history will be recorded for the purpose of the study. Symptomatic patients will undergo haematoma removal either by burr-hole drainage or craniotomy. They will undergo a series of CT-scans before and after treatment to assess the characteristics of the haematoma (size, side, site, composition of the haematoma, etc). Patients will then be divided into the embolization group and the control group. Patients with residual or recurrent haematoma (higher than 10mm thickness of haematoma at any dimension) following prior surgical evacuation of haematoma will be admitted to the Embolization Group and undergo embolization of MMA. Serial CT scans will be taken at times of presentation of the residual or recurrent haematoma, 1-day, 1-week, 1-month, 3-month, and 6-month following embolization. Size of haematoma will be measured for comparison to the Control Group. Clinical examinations will be done at the same setting. For the control group, after the initial treatment of haematoma removal, they will be monitored clinically for signs of neurological deficits, presentation of symptoms. They remain in control group should they refuse entering the MMA embolization group. They will have the same clinical and radiological follow-up as the embolization group.
MMA embolization will be performed with a liquid embolization agent with local anaesthesia. Selective angiography will be performed before embolization to select MMA branch targets and detect potentially dangerous collateral vessels. If no dangerous collaterals are found, MMA branches supplying to the dura of convexity will be targeted and embolized according to findings of the selective angiography using a liquid embolization agent. If dangerous collaterals are identified, the microcatheter will be advanced more distally or the collaterals will be coiled prior to embolization. Procedure will be concluded once the flow stasis of MMA is confirmed. Embolization is considered successful if all MMA targets are embolized without procedural complications.
Patients with existing use of antiplatelet or anticoagulation medication will not undergo medication reversal for the embolization procedure.
Patients will be discharged following treatment based on the results of the post-operative assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients divided into two groups, embolization group and control (conventional) group. Patients remain in control group if they refuse embolization.
| Arm | Type | Receives |
|---|---|---|
| Embolization Group | Experimental | Procedure: Middle meningeal artery embolizationPatients with residual or recurrent haematoma (higher than 10mm thickness of haematoma at any dimension) following prior surgical evacuation of haematoma will be admitted to the Embolization Group and undergo embolization of MMA. Serial CT scans will be taken at times of presentation of the residual or recurrent haematoma, 1-day, 1-week, 1-month, 3-month, and 6-month following embolization. Size of haematoma will be measured for comparison to the Control Group. Clinical examinations will be done at the same setting. |
| Control Group | No intervention | –All symptomatic patients (headache unresponsive to analgesic or neurological deficits including focal neurological deficits, deteriorated consciousness, headache, seizures, and other signs or symptoms suggestive of SDH as the cause) will undergo haematoma evacuation either by burr-hole drainage or craniotomy. Their response to treatment, neurological status, and CT scans will be monitored. Asymptomatic patients will be monitored radiologically (CT) every 2-4 weeks. The decision for surgical evacuation of haematoma will be based on CT findings (increasing haematoma size) and presentation of symptoms or neurological deficits. They remain in the control group should they refuse embolization of MMA. The size of haematoma will be measured continuously based on CT scans taken at times of presentation, 1-day, 1-week, 1-month, 3-month, and 6-month post-op. Size of haematoma, residual or recurrent will be measured for comparison to the Embolization Group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (age 18 or above) with chronic subdural haematoma diagnosed by computed tomography and clinical presentation.
Key exclusion criteria (3 listed)
- SDH with thickness of 10mm or less, lack of mass effect.
- SDH secondary to existing conditions (brain tumour, arachnoid cyst, spontaneous intracranial hypotension, previous craniotomy not due to chronic SDH)
- Patients in poor medication condition or with life expectancy less than 6 months.
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 |
|---|---|---|
| Middle meningeal artery embolizationMMA embolization will be performed with a liquid embolization agent with local anaesthesia. Selective angiography will be performed before embolization to select MMA branch targets and detect potentially dangerous collateral vessels. If no dangerous collaterals are found, MMA branches supplying to the dura of convexity will be targeted and embolized according to findings of the selective angiography using a liquid embolization agent. If dangerous collaterals are identified, the microcatheter will be advanced more distally or the collaterals will be coiled prior to embolization. Procedure will be concluded once the flow stasis of MMA is confirmed. Embolization is considered successful if all MMA targets are embolized without procedural complications. Patients with existing use of antiplatelet or anticoagulation medication will not undergo medication reversal for the embolization procedure. | Procedure or surgery | Embolization Group |
Primary outcome
Percentage volume change of recurrent haematoma
Time frame: From date of recruitmnent until the date of first documented progression or date of death from any cause or at 6 months, whichever came first
Primary outcome of the studies is the percentage volume change of recurrent haematoma measured by serial CT brain scans after embolization (embolization group) or haematoma removal (control group).
2 secondary outcomes
Number of patients with treatment failure
Time frame: From date of recruitment until the date of first documented progression or date of death from any cause or at 6 months, whichever came first
Number of patients with 30-day morbidities and mortality
Time frame: 30 days following the day of recruitment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: Undecided. Not decided yet.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Middle meningeal artery embolization in people with Chronic Subdural Hematoma and Subdural Hematoma, run by Chinese University of Hong Kong at 1 site 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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage volume change of recurrent haematoma (time frame: From date of recruitmnent until the date of first documented progression or date of death from any cause or at 6 months, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2024.