- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04500795
Prospective Study on the Use of Middle Meningeal Artery Embolization for Chronic Subdural Haematoma
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hong Kong, China
- Department of Surgery, The Chinese University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients (age 18 or above) with chronic subdural haematoma diagnosed by computed tomography and clinical presentation.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Embolization 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.
|
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. |
No Intervention: Control Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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).
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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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
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Number of patients with 30-day morbidities and mortality
Time Frame: 30 days following the day of recruitment
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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).
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30 days following the day of recruitment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Disease Attributes
- Hemorrhage
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Intracranial Hemorrhage, Traumatic
- Chronic Disease
- Hematoma
- Hematoma, Subdural
- Hematoma, Subdural, Chronic
Other Study ID Numbers
- GWMMAE01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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