Curcumin/Turmeric as a Treatment for Patients With Subdural Hematomas Recurrence

• Status: Recruiting
• Trial end date: 2022-09-28
• Target enrollment: 0
• Participant gender: All

Summary

Our long-term objective is to evaluate the efficacy of curcumin (CC) in preventing a recurrence of chronic subdural hematoma (cSDH) following surgical evacuation. Recurrence is defined as an increase in total hematoma volume on the operated side compared to a post-operative day one CT scan with persistent or recurrent neurological symptoms. The investigators propose this pilot study to assess feasibility and obtain preliminary benefit assessment of the proposed therapeutic approach.

Objective 1: To determine if the use of CC treatment reduces the total hematoma cavity volume over a 6-month interval, compared to a post-subdural drain removal CT scan. This evaluation is expected to offer sufficient evidence for a larger definitive trial.

Objective 2: Study the effect of CC on interleukin-8 (IL-8)-induced disruption of endothelial permeability in vitro using human vascular endothelial cells.

Central hypothesis: CC treatment prevents the re-accumulation of cSDH, which may occur by inhibition of IL-8 and allowing resolution of the total hematoma cavity volume over six months.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of New Mexico
• Treatments: Curcumin; Turmeric extract

Criteria

Inclusion Criteria:

1. Chronic subdural hematoma (cSDH)

2. Age of 18 years old or older

3. Unilateral cSDH with no other intracranial injuries

o Membranes with minimal hemorrhage may be included but no clear acute component should be evident

4. Subdural volume less than 115cc

5. MARWALDER GRADING SCALE Score of 0-2

6. Patient or patient's power of attorney (POA) is available to sign consent

7. Patient undergoes surgical evacuation of cSDH-

Exclusion Criteria:

1. Age less than 18 years old

2. Bilateral subdural hematomas

3. Subdural volume less than 115cc

4. Acute subdural hematoma

5. Patient does not undergo surgical evacuation

6. Other evidence of intracranial injury (i.e. epidural hematoma, intraparenchymal hemorrhage, skull fractures, subarachnoid hemorrhage, hydrocephalus)

7. Patient's family not available for consent and requires emergent surgical evacuation

8. Previous intracranial surgery

9. Recent head trauma (less than1 week)

10. Use of anti-coagulation (i.e. Coumadin, Heparin, Apixaban, and Rivaroxaban) or antiplatelets (Plavix) drugs, with the exception of Aspirin

11. Known coagulopathy disorders

12. Positive urine or serum pregnancy test in pre-menopausal female subjects, without a documented history of surgical sterilization; or currently breastfeeding (Since the nuclear group in an older population, the pregnancy test will be made in exceptional cases).

13. Allergy to curcumin or turmeric.

14. Allergy to black pepper

15. Markwalder Grading Scale Score: 3-4

16. Baseline dementia (for more than 6 months). Adult who cognitively impaired for more than 6 months will be excluded from the study, since this impairment might be due to other reasons than cSDH, such as dementia or cognitive impairment.