search
Back to results

Endovascular Embolization of Chronic Subdural Hematomas After Surgery (ENCLOSURE)

Primary Purpose

Chronic Subdural Hematoma

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro)
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring Middle meningeal artery embolization

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hospital Universitari Vall d'HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Surgical drainaje (the standar of care)

Surgical drainaje plus early embolization of middle meningeal artery

Arm Description

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.

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®.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional status
Measured by modified Rankin scale (range, 0 [no disability] to 6 [death])
Safety of endovascular treatment
Measured by complications related to endovascular procedure
Hematoma reabsorption speed
Measured by hematoma volume after treatment on CT imaging
Cumulative days of hospital stay
Measured in both groups (surgical alone and surgical plus endovascular)

Full Information

First Posted
January 4, 2022
Last Updated
March 4, 2022
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05220826
Brief Title
Endovascular Embolization of Chronic Subdural Hematomas After Surgery
Acronym
ENCLOSURE
Official Title
Early eNdovascular Embolization for Chronic subduraL hematOma After SUrgery and Prevention of REcurrence (ENCLOSURE)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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%). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
Keywords
Middle meningeal artery embolization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Primary outcome will be assesed by a blinded external core lab
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical drainaje (the standar of care)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Surgical drainaje plus early embolization of middle meningeal artery
Arm Type
Experimental
Arm Description
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®.
Intervention Type
Procedure
Intervention Name(s)
Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro)
Other Intervention Name(s)
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.
Intervention Description
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®.
Primary Outcome Measure Information:
Title
Recurrence of chronic subdural hematoma
Description
Defined ad reappearance of symptomatic blood collection or whose thickness is > 1 cm or which determines a deviation from the midline> 5 mm
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Functional status
Description
Measured by modified Rankin scale (range, 0 [no disability] to 6 [death])
Time Frame
6 months
Title
Safety of endovascular treatment
Description
Measured by complications related to endovascular procedure
Time Frame
6 months
Title
Hematoma reabsorption speed
Description
Measured by hematoma volume after treatment on CT imaging
Time Frame
6 months
Title
Cumulative days of hospital stay
Description
Measured in both groups (surgical alone and surgical plus endovascular)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Tomasello, MD
Phone
93489300
Ext
6441
Email
alejandrotomasello@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Luis Cuevas, MD
Phone
93489300
Ext
6748
Email
cuevasseguel.joseluis@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Tomasello, MD
Organizational Affiliation
Hospital Universitari Vall d'hebron Barcelona, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jose Luis Cuevas, MD
Organizational Affiliation
Hospital de Puerto Montt, Puerto Montt, Chile.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Tomasello, MD
Phone
93489300
Ext
6441
Email
alejandrotomasello@gmail.com
First Name & Middle Initial & Last Name & Degree
Jose Luis Cuevas, MD
Phone
93489300
Ext
6748
Email
cuevasseguel.joseluis@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endovascular Embolization of Chronic Subdural Hematomas After Surgery

We'll reach out to this number within 24 hrs