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Embolization of the Middle Meningeal Artery for the Prevention of Chronic Subdural Hematoma Recurrence in High Risk Patients (EMPROTECT)

NCT04372147 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2024-09-23

No results posted yet for this study

Summary

Standard of care for the management of symptomatic chronic subdural hematomas (SDHs) is neurosurgical burr-hole evacuation followed by drainage. Post-operative recurrence rates may be as high as 10 to 20 %. In particular, recurrence rate increases with antiplatelet and anticoagulant therapy. Middle meningeal artery (MMA) embolization has been proposed as a novel treatment of chronic SDH. The aim of this study is to assess the efficacy of MMA embolization in reducing the risk of chronic SDH recurrence at 6 months after burr-hole surgery as compared with standard medical post-operative treatment in patients at high risk of post-operative recurrence.

Conditions

  • Chronic Subdural Hematoma
  • At Risk of Post-operative Recurrence
  • Burr-hole Surgery

Interventions

PROCEDURE

MMA embolization

Patients in the intervention group will undergo a CT angiography scan of the supra aortic trunks, followed by MMA embolization procedure within 7 days of the burr-hole surgery in addition to standard medical care

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Eimad Shotar, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-22
Primary Completion
2023-10-23
Completion
2023-10-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04372147 on ClinicalTrials.gov