Chronic Subdural HematomaENCLOSURENCT05220826
Endovascular Embolization of Chronic Subdural Hematomas After Surgery
A study testing Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro) in people with Chronic Subdural Hematoma, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Chronic subdural hematomas (CSH) are one of the most frequent pathologies in emergency neurosurgical practice. Standard therapy for symptomatic CSH is surgical drainage. However, the recurrence rate after surgery is high (10 to 20% in the most of series, although it has been reported from 2 to 37%). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSpain
- Study dates
- 11 Feb 2022to Dec 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic subdural hematoma equal or greater than 10 mm, midline shift equal or greater than 5 mm or neurological symptoms attributable to mass effect.
- Recent diagnosis or recurrence
- Surgical treatment performed < 72 hours
- Informed consent signed by the patient or they responsible family member
Who cannot join
- Advanced disease with life expectancy < 6 months
- Condition that contraindicated endovascular procedure: Pregnancy, renal failure defined as creatinine clearence < 30 ml/min, allergy to iodinated contrast.
- Unavailability for follow up st 6 months
- Patient expressly refuses treatment
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Alejandro Tomasello, MD, 93489300 ext. 6441, alejandrotomasello@gmail.com
Jose Luis Cuevas, MD, 93489300 ext. 6748, cuevasseguel.joseluis@gmail.com
About this study
Official title: Early eNdovascular Embolization for Chronic subduraL hematOma After SUrgery and Prevention of REcurrence (ENCLOSURE)
Chronic subdural hematomas (CSH) are one of the most frequent pathologies in emergency neurosurgical practice. Standard therapy for symptomatic CSH is surgical drainage. However, the recurrence rate after surgery is high (10 to 20% in the most of series, although it has been reported from 2 to 37%). Middle meningeal artery embolization (MMAE) is a promising minimally invasive procedure that has recently been proposed as an alternative or adjunctive treatment to surgery. The investigators hypothesize that early post operative endovascular treatment can reduce the recurrence rate in high-risk patients, improving neurological outcomes by reducing the need for reinterventions, hospitalizations, and post-operative complications. The aim of the investigators is to analyze the efficacy of and safety of early post-surgical embolization of MMA in reducing the risk of CSH recurrence.
Read the detailed description
The study was designed as an open-label, multicenter randomized trial involving patients with symptomatic CSH and surgical evacuation criteria. Patients will be randomized in a 1: 1 ratio to receive surgical drainage (the standard of care) or surgical drainage plus early endovascular embolization of MMA (< 72 hours after surgery). Endovascular procedures will be performed with non-adhesive embolizing fluids. The primary outcome will be the recurrence of CSH at 6 months and secondary outcomes will be the risk reduction of recurrence in patients with risk factors, functional status measured by the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 6 months and complications related to endovascular procedure.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro)
- Keywords
- Middle meningeal artery embolization
- 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.
Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro)Procedure or surgery
Also called Liquid embolic agent: Onix (ethylene vinyl alcohol copolymer), Medtronic., Liquid embolic agent: Squid (ethylene vinyl alcohol copolymer), Balt., Liquid embolic agent: Phil (copolymer disolved in DMSO), Microvention-Terumo., Liquid embolic agent: Libro (ethylene vinyl aalcohol copolymer), Invamed.
The endovascular procedure will be performed until 72 hours after surgical evacuation of chronic subdural hematoma. Embolization will be performed with non-adhesive embolizing fluids such as Onix®, Phil®, Squid® or Libro®.
| Study group | Role | What they receive |
|---|---|---|
| Surgical drainaje (the standar of care) | No intervention | Surgery will consist of performing a craniotomy (burr hole or drill) and evacuation of the hematoma. Depending on the operator, the surgical procedure may incorporate the use of subdural space drainage devices (e.g. Jackson Pratt drainage) connected to a soft suction reservoir. If used, these devices should be removed within 48 hours of installation. |
| Surgical drainaje plus early embolization of middle meningeal artery | Experimental | The endovascular procedure will be performed until 72 hours after surgical evacuation of chronic subdural hematoma. Embolization will be performed with non-adhesive embolizing fluids such as Onix®, Phil®, Squid® or Libro®. Receives: Procedure: Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of chronic subdural hematoma
Defined ad reappearance of symptomatic blood collection or whose thickness is > 1 cm or which determines a deviation from the midline> 5 mm
Measured: 6 months
Secondary outcomes (4)
Functional status
Measured by modified Rankin scale (range, 0 [no disability] to 6 [death])
Measured: 6 months
Safety of endovascular treatment
Measured by complications related to endovascular procedure
Measured: 6 months
Hematoma reabsorption speed
Measured by hematoma volume after treatment on CT imaging
Measured: 6 months
Cumulative days of hospital stay
Measured in both groups (surgical alone and surgical plus endovascular)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start11 Feb 2022
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (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.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- 280 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Tomasello, MD, Study chair, Hospital Universitari Vall d'hebron Barcelona, SpainJose Luis Cuevas, MD, Principal investigator, Hospital de Puerto Montt, Puerto Montt, Chile.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220826
- Sponsor's protocol ID
- PR(AG)575/2021
- Acronym
- ENCLOSURE
- Status last verified
- Mar 2022
- First submitted
- 4 Jan 2022
- Last updated
- 21 Mar 2022
- 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 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early eNdovascular Embolization for Chronic subduraL hematOma After SUrgery and Prevention of REcurrence (ENCLOSURE)
- ClinicalTrials.gov ID
- NCT05220826
- Acronym / sponsor ID
- ENCLOSURE / PR(AG)575/2021
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Middle meningeal artery embolization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Feb 2022 (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.
Chronic subdural hematomas (CSH) are one of the most frequent pathologies in emergency neurosurgical practice. Standard therapy for symptomatic CSH is surgical drainage. However, the recurrence rate after surgery is high (10 to 20% in the most of series, although it has been reported from 2 to 37%). Middle meningeal artery embolization (MMAE) is a promising minimally invasive procedure that has recently been proposed as an alternative or adjunctive treatment to surgery. The investigators hypothesize that early post operative endovascular treatment can reduce the recurrence rate in high-risk patients, improving neurological outcomes by reducing the need for reinterventions, hospitalizations, and post-operative complications. The aim of the investigators is to analyze the efficacy of and safety of early post-surgical embolization of MMA in reducing the risk of CSH recurrence.
Detailed description
The study was designed as an open-label, multicenter randomized trial involving patients with symptomatic CSH and surgical evacuation criteria. Patients will be randomized in a 1: 1 ratio to receive surgical drainage (the standard of care) or surgical drainage plus early endovascular embolization of MMA (< 72 hours after surgery). Endovascular procedures will be performed with non-adhesive embolizing fluids. The primary outcome will be the recurrence of CSH at 6 months and secondary outcomes will be the risk reduction of recurrence in patients with risk factors, functional status measured by the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 6 months and complications related to endovascular procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical drainaje (the standar of care) | No intervention | –Surgery will consist of performing a craniotomy (burr hole or drill) and evacuation of the hematoma. Depending on the operator, the surgical procedure may incorporate the use of subdural space drainage devices (e.g. Jackson Pratt drainage) connected to a soft suction reservoir. If used, these devices should be removed within 48 hours of installation. |
| Surgical drainaje plus early embolization of middle meningeal artery | Experimental | Procedure: Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro)The endovascular procedure will be performed until 72 hours after surgical evacuation of chronic subdural hematoma. Embolization will be performed with non-adhesive embolizing fluids such as Onix®, Phil®, Squid® or Libro®. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic subdural hematoma equal or greater than 10 mm, midline shift equal or greater than 5 mm or neurological symptoms attributable to mass effect.
- Recent diagnosis or recurrence
- Surgical treatment performed < 72 hours
- Informed consent signed by the patient or they responsible family member
Key exclusion criteria (4 listed)
- Advanced disease with life expectancy < 6 months
- Condition that contraindicated endovascular procedure: Pregnancy, renal failure defined as creatinine clearence < 30 ml/min, allergy to iodinated contrast.
- Unavailability for follow up st 6 months
- Patient expressly refuses treatment
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 |
|---|---|---|
| Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro)Also: Liquid embolic agent: Onix (ethylene vinyl alcohol copolymer), Medtronic., Liquid embolic agent: Squid (ethylene vinyl alcohol copolymer), Balt., Liquid embolic agent: Phil (copolymer disolved in DMSO), Microvention-Terumo., Liquid embolic agent: Libro (ethylene vinyl aalcohol copolymer), Invamed.The endovascular procedure will be performed until 72 hours after surgical evacuation of chronic subdural hematoma. Embolization will be performed with non-adhesive embolizing fluids such as Onix®, Phil®, Squid® or Libro®. | Procedure or surgery | Surgical drainaje plus early embolization of middle meningeal artery |
Primary outcome
Recurrence of chronic subdural hematoma
Time frame: 6 months
Defined ad reappearance of symptomatic blood collection or whose thickness is > 1 cm or which determines a deviation from the midline> 5 mm
4 secondary outcomes
Functional status
Time frame: 6 months
Safety of endovascular treatment
Time frame: 6 months
Hematoma reabsorption speed
Time frame: 6 months
Cumulative days of hospital stay
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- 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.
Alejandro Tomasello, MD study chair
Hospital Universitari Vall d'hebron Barcelona, Spain
Jose Luis Cuevas, MD principal investigator
Hospital de Puerto Montt, Puerto Montt, Chile.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro) in people with Chronic Subdural Hematoma, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 4 inclusion and 4 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 21 Mar 2022. 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 Spain. 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 Alejandro Tomasello, MD (93489300 ext. 6441, alejandrotomasello@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of chronic subdural hematoma (time frame: 6 months). 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 Mar 2022.