Endovascular embolization for chronic subdural hematomas after surgery
Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation
This study is testing if adding a less invasive procedure to the usual surgery for chronic subdural hematomas can help prevent these blood clots from coming back in older patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Augusta University Academic / other |
| Locations | 1 site (Augusta, Georgia) |
| Trial ID | NCT04272996 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of endovascular embolization of the middle meningeal artery in patients who have undergone surgical evacuation of chronic subdural hematomas (SDHs). The aim is to assess whether this less invasive approach can reduce the rate of recurrence of SDHs, which is a significant concern, especially in elderly patients who are at high risk for surgical complications. Participants will be randomly assigned to either a control group receiving only surgical evacuation or a treatment group receiving both surgical evacuation and embolization. The study seeks to provide a direct comparison of outcomes between these two approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 with chronic SDH requiring surgical evacuation and a Glasgow Coma Scale score greater than 6.
Not a fit: Patients under 18 or over 90 years of age, those with severe comorbidities, or those unable to consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of chronic subdural hematomas, leading to better patient outcomes and fewer reoperations.
How similar studies have performed: While there have been positive reports on endovascular embolization for SDHs, this study is novel as it directly compares this technique following surgical evacuation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 18-90 with chronic SDH * Patients that require surgical evacuation of SDH following assessment by a neurosurgeon * Glasgow Coma Scale (GCS) \>6 * Modified Rankin Scale (mRs) \<5 Exclusion Criteria: * Patients \< 18 or \>90 years of age * Pregnancy * Patients with extensive multisystem trauma requiring multidisciplinary surgical interventions * Chronic renal insufficiency with creatinine \>1.8 * GCS \<6 * mRs \>4 * Genetic bleeding disorder * Liver failure * Coagulopathy * Patients unable to consent who do not have an LAR available
Where this trial is running
Augusta, Georgia
- Augusta University — Augusta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Fernando L. Vale, M.D. — Medical College of Georgia-Augusta University
- Study coordinator: Fernando L Vale, M.D.
- Email: fvalediaz@augusta.edu
- Phone: 7067213071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.