Chronic Subdural HematomaNCT04574843
Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma
A study testing Embolization of MMA in people with Chronic Subdural Hematoma, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The study evaluates the clinical and imaging outcome of middle meningeal artery (MMA) embolization with liquid embolic agent for treatment of chronic subdural hematoma (CSDH) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Embolization of MMA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- 1 Aug 2020to 31 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed chronic or subacute subdural hematoma
- Patients had symptoms/signs associated with chronic or subacute subdural hematoma: severe headache, hemiparesis/monoparesis, dementia, aphasia/dysphasia, loss of consciousness, ...
- Asymptomatic large chronic/subacute hematoma after 6-8 weeks of failed conservative treatment
Who cannot join
- presentation with coma (GCS =< 8)
- patients needs emergent evacuation of hematoma,
- patients could not participate in 60 days follow-up
- pregnant patients
- acute subdural hematoma
- contraindication to contrast
Show all 10Show fewer
- contradiction to angiography
- difficult access to MMA due to anatomical variation
- contraindication to liquid embolic agent
- unmanaged/uncontrollable bleeding disorders
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ghaem Hospital, Mashhad University of Medical Sciences
Mashhad
Humain Baharvahdat, MD, +98-915-110-0400, humainbv@yahoo.fr
Feizollah EBRAHIMNIA, MD
About this study
The study evaluates the clinical and imaging outcome of middle meningeal artery (MMA) embolization with liquid embolic agent for treatment of chronic subdural hematoma (CSDH)
Read the detailed description
This study is a prospective one arm trial designed to assess the safety and efficacy of MMA embolization with liquid embolic agents (onyx/squid/Phil) as the main treatment of CSDH.
The subjects are enrolled in the study according to inclusion and exclusion criteria. Imaging and clinical presentations of patients are recorded. Within 48 hours of embolization, patients are assessed with clinical examination and with a brain CT scan to evaluate in any change in their symptoms and CSDH volume. 2-4 weeks after embolization, patients are evaluated in clinic for any change in their symptoms and signs. 60 days after embolization patients are examined clinically and are assessed for SDH volume change in CT scan and MRI.
If there is any significant increase in CSDH volume or any deterioration of patient, evacuation of hematoma is considered.
MMA embolization is performed under general anesthesia using biplane or monoplane angiography. Femoral or radial accesses are used. Guiding catheter is advanced into external carotid artery in corresponding side. The corresponding MMA is catheterized distally by micro-catheter and is embolized by liquid embolic agents. Patients are discharge next day if they are stable.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Embolization of MMA
- Keywords
- chronic subdural hematoma, embolization, middle meningeal artery, liquid embolic agent
- 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.
Embolization of MMAProcedure or surgery
Also called Onyx, Squid, Phil
embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil)
| Study group | Role | What they receive |
|---|---|---|
| Embolization arm | Experimental | Intervention: Embolization of middle meningeal artery Device: Onyx, squid, Phil Receives: Procedure: Embolization of MMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CSDH regression
Volume reduction of CSDH in follow-up imaging (CT/MRI) 60 days after embolization
Measured: 60 dyas
Secondary outcomes (7)
Incidence of CSDH progression or recurrence
Increase in volume of CSDH
Measured: 60 days
Incidence of new neurological deficit (ND)
ND includes: dementia, memory loss, cognitive problems, monoparesis/hemiparesis, cranial nerve paresis, dysphasia/aphasia
Measured: 60 days
incidence of Death
Measured: 60 days
Incidence of new ischemic stroke
new ischemia in imaging (DWI/MRI or CT scan) within 60 days of operation
Measured: 60 days
Incidence of myocardial infarction/myocardial ischemia
new ischemic heart attack within 60 days of operation
Measured: 60 days
Incidence of embolization complication in brain
cranial nerve palsy (especially VII), vision loss (ophthalmic/retinal artery occlusion), ...
Measured: 48 hours
incidence of embolization complication out of brain
puncture hematoma, major artery dissection, new renal failure, ...
Measured: 15 days
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 start1 Aug 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humain Baharvahdat, Mashhad University of Medical Sciences
- Investigators
- Humain Baharvahdat, MD, Study director, Department of Neurosurgery, Mashhad University of Medical Sciences, Mashhad, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574843
- Sponsor's protocol ID
- 990631
- Status last verified
- May 2023
- First submitted
- 29 Sep 2020
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT04574843
- Acronym / sponsor ID
- 990631
- Conditions
- Chronic Subdural Hematoma
- Keywords
- chronic subdural hematoma, embolization, middle meningeal artery, liquid embolic agent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- 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.
The study evaluates the clinical and imaging outcome of middle meningeal artery (MMA) embolization with liquid embolic agent for treatment of chronic subdural hematoma (CSDH)
Detailed description
This study is a prospective one arm trial designed to assess the safety and efficacy of MMA embolization with liquid embolic agents (onyx/squid/Phil) as the main treatment of CSDH.
The subjects are enrolled in the study according to inclusion and exclusion criteria. Imaging and clinical presentations of patients are recorded. Within 48 hours of embolization, patients are assessed with clinical examination and with a brain CT scan to evaluate in any change in their symptoms and CSDH volume. 2-4 weeks after embolization, patients are evaluated in clinic for any change in their symptoms and signs. 60 days after embolization patients are examined clinically and are assessed for SDH volume change in CT scan and MRI.
If there is any significant increase in CSDH volume or any deterioration of patient, evacuation of hematoma is considered.
MMA embolization is performed under general anesthesia using biplane or monoplane angiography. Femoral or radial accesses are used. Guiding catheter is advanced into external carotid artery in corresponding side. The corresponding MMA is catheterized distally by micro-catheter and is embolized by liquid embolic agents. Patients are discharge next day if they are stable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolization arm | Experimental | Procedure: Embolization of MMAIntervention: Embolization of middle meningeal artery Device: Onyx, squid, Phil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients diagnosed chronic or subacute subdural hematoma
- Patients had symptoms/signs associated with chronic or subacute subdural hematoma: severe headache, hemiparesis/monoparesis, dementia, aphasia/dysphasia, loss of consciousness, ...
- Asymptomatic large chronic/subacute hematoma after 6-8 weeks of failed conservative treatment
Key exclusion criteria (10 listed)
- presentation with coma (GCS =< 8)
- patients needs emergent evacuation of hematoma,
- patients could not participate in 60 days follow-up
- pregnant patients
- acute subdural hematoma
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 |
|---|---|---|
| Embolization of MMAAlso: Onyx, Squid, Philembolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil) | Procedure or surgery | Embolization arm |
Primary outcome
Incidence of CSDH regression
Time frame: 60 dyas
Volume reduction of CSDH in follow-up imaging (CT/MRI) 60 days after embolization
7 secondary outcomes
Incidence of CSDH progression or recurrence
Time frame: 60 days
Incidence of new neurological deficit (ND)
Time frame: 60 days
incidence of Death
Time frame: 60 days
Incidence of new ischemic stroke
Time frame: 60 days
Incidence of myocardial infarction/myocardial ischemia
Time frame: 60 days
Incidence of embolization complication in brain
Time frame: 48 hours
incidence of embolization complication out of brain
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- 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.
Humain Baharvahdat, MD study director
Department of Neurosurgery, Mashhad University of Medical Sciences, Mashhad, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embolization of MMA in people with Chronic Subdural Hematoma, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 10 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: status not confirmed, as of the sponsor's last update on 19 May 2023. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Humain Baharvahdat, MD (+98-915-110-0400, humainbv@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CSDH regression (time frame: 60 dyas). 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 19 May 2023.