RECRUITING

Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is designed to evaluate the effectiveness of endovascular embolization of middle meningeal artery following evacuation of subdural hematomas (SDHs) to assess rate of recurrence. The historical standard for treatment of subdural hematomas has been surgical evacuation through burr holes or craniotomies. Many of these patients are elderly patients who are high risk surgical candidates. A major concern is SDH recurrence. Recurrences require frequent imaging, and will lead to increased length of hospital stay, increased morbidity,and re-operations. There are increasing number of reports that suggest that a less invasive approach such as endovascular embolization of the middle meningeal artery using standard endovascular materials and techniques may reduce the risk of recurrence. The reported outcomes in the current literature have been very positive when endovascular embolization has been used without surgery or as an adjuvant to surgery. However, there have been no studies directly comparing endovascular embolization following surgical evacuation to assess if this technique can actually reduce the complications of SDHs listed above. The investigators propose to study this treatment process by randomly assigning patients who have undergone surgical evacuation of SDHs into a control and treatment group. The control group will receive standard surgical evacuation of the hematoma. The study group will receive surgical evacuation followed by endovascular embolization.

Official Title

Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation

Quick Facts

Study Start:2019-03-01
Study Completion:2024-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04272996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients 18-90 with chronic SDH
  2. * Patients that require surgical evacuation of SDH following assessment by a neurosurgeon
  3. * Glasgow Coma Scale (GCS) \>6
  4. * Modified Rankin Scale (mRs) \<5
  1. * Patients \< 18 or \>90 years of age
  2. * Pregnancy
  3. * Patients with extensive multisystem trauma requiring multidisciplinary surgical interventions
  4. * Chronic renal insufficiency with creatinine \>1.8
  5. * GCS \<6
  6. * mRs \>4
  7. * Genetic bleeding disorder
  8. * Liver failure
  9. * Coagulopathy
  10. * Patients unable to consent who do not have an LAR available

Contacts and Locations

Study Contact

Fernando L Vale, M.D.
CONTACT
7067213071
fvalediaz@augusta.edu
Patty Ray, PhD
CONTACT
706-721-9680
paray@augusta.edu

Principal Investigator

Fernando L. Vale, M.D.
PRINCIPAL_INVESTIGATOR
Medical College of Georgia-Augusta University

Study Locations (Sites)

Augusta University
Augusta, Georgia, 30912
United States

Collaborators and Investigators

Sponsor: Augusta University

  • Fernando L. Vale, M.D., PRINCIPAL_INVESTIGATOR, Medical College of Georgia-Augusta University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-01
Study Completion Date2024-06

Study Record Updates

Study Start Date2019-03-01
Study Completion Date2024-06

Terms related to this study

Keywords Provided by Researchers

  • subdural hematoma
  • embolization
  • middle meningeal artery

Additional Relevant MeSH Terms

  • Chronic SDH and the Efficacy of Embolization