Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

Chronic Subdural Hematoma Clinical Trial

— CHESS  

Official title:

Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06347796
• Other study ID #: 23-0160
• Secondary ID: 1UG3NS128397-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2029

Study information

• Verified date: March 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: Jessica Spahn
• Phone: 262-470-4293
• Email: jlspahn[@]utmb.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are: - Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths? - What is the safety of MMAE and conventional open surgery in these patients? Participants will be asked to: - Share their medical history and undergo physical examinations - Have blood drawn - Have CT scans of the head - Answer questionnaires - Undergo MMAE or conventional open surgery - Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 520
• Est. completion date: September 2029
• Est. primary completion date: September 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age 40-90 years inclusively.

2. Per CT of the head, (one of the following): Unilateral convexity CSDH measuring at least 10 mm in thickness OR Bilateral CSDH if only one side is considered for treatment and the contralateral side is asymptomatic and < 5 mm in thickness.

3. CSDH at least 2/3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying CSDH.

4. Qualifying baseline head CT performed within the 7 days prior to randomization.

5. Able to undergo assigned treatment within 48 hours after randomization.

6. Patient or legally authorized representative agrees to be randomized, and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.

Exclusion Criteria:

1. Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor.

2. Tentorial or interhemispheric SDH.

3. Previous craniotomy for the treatment of CSDH if the craniotomy exceeds 7 cm at the maximal dimension on the baseline CT.

4. mRS of 5 or higher.

5. Emergent surgical evacuation such as open craniotomy, burr hole drainage, or Subdural Evacuating Port System (SEPS) is required for the patient.

6. Unable to withhold all antiplatelet agents or OACs for the first 7 days after randomization.

7. Indication that withdrawal of care will be implemented for the qualifying SDH.

8. Prior surgical treatment for CSDH if the surgery is less than 30 days prior to randomization.

9. On tranexamic acid.

10. Platelet count of <100,000 per microliter refractory to transfusion.

11. Coagulopathy that cannot be corrected to an INR of =1.5.

12. Known contraindications to angiography.

13. Known intolerance to occlusion procedures.

14. Known vascular anatomy (small artery size) or blood flow (high vascular resistance peripheral to the feeding arteries) that precludes catheter placement or embolic agent (Embosphere Microspheres or CONTOUR particles) injection.

15. Known presence of collateral vessel pathways potentially endangering normal territories or cranial nerves during embolization.

16. Known large diameter arteriovenous shunt, i.e., where the blood does not pass through an arterial/capillary/venous transition but directly from an artery to a vein or presence of patent extra-to-intracranial anastomoses (where study embolization devices could pass directly into the internal carotid artery, vertebral artery, or intracranial vasculature) that cannot be addressed with coil embolization.

17. Patient has a known active systemic infection or sepsis.

18. Patient is pregnant, planning to become pregnant, or lactating.

19. Life expectancy of less than 6 months due to comorbid terminal conditions.

20. Concurrent participation in another research protocol for investigation of an experimental therapy.

21. Known or suspected to not be able to comply with the study protocol.

22. No measurable deficit on the Timed Up and Go [TUG], Aphasia Severity Rating [ASR], or MRC.

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Procedure:
• Conventional Surgery
Conventional surgery is surgical drainage through burr holes or craniotomy.

Device:
• Middle Meningeal Artery Embolization (MMAE)
Particle embolization of the middle meningeal artery with micron variants of the Embosphere Microspheres or CONTOUR Embolization Particles device.

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for Rescue Surgery or Death	Participants who need rescue surgery or die.	Within 180-210 days of randomization
Secondary	Safety of MMAE and Conventional Open Surgery	The proportion of subjects with symptomatic ischemic stroke, serious/life threatening adverse events, worsening of neurological status (a decline of 1 point on the Markwalder scale) or development of new disabling neurological symptoms, seizures, and/or cranial neuropathy.	Within 180 days of randomization.