Status:
WITHDRAWN
Curcumin/Turmeric as a Treatment for Patients With Subdural Hematomas Recurrence
Lead Sponsor:
University of New Mexico
Conditions:
Hematoma, Subdural, Chronic
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
Chronic subdural hematomas (cSDH) are extra-axial fluid collections in the cranium that can result in brain compression and neurological decline. cSDH commonly occurs after traumatic brain injury (TBI...
Eligibility Criteria
Inclusion
- Chronic subdural hematoma (cSDH)
- Age of 18 years old or older
- Unilateral cSDH with no other intracranial injuries
- o Membranes with minimal hemorrhage may be included but no clear acute component should be evident
- Subdural volume less than 115cc
- MARWALDER GRADING SCALE Score of 0-2
- Patient or patient's power of attorney (POA) is available to sign consent
- Patient undergoes surgical evacuation of cSDH-
Exclusion
- Age less than 18 years old
- Bilateral subdural hematomas
- Subdural volume less than 115cc
- Acute subdural hematoma
- Patient does not undergo surgical evacuation
- Other evidence of intracranial injury (i.e. epidural hematoma, intraparenchymal hemorrhage, skull fractures, subarachnoid hemorrhage, hydrocephalus)
- Patient's family not available for consent and requires emergent surgical evacuation
- Previous intracranial surgery
- Recent head trauma (less than1 week)
- Use of anti-coagulation (i.e. Coumadin, Heparin, Apixaban, and Rivaroxaban) or antiplatelets (Plavix) drugs, with the exception of Aspirin
- Known coagulopathy disorders
- 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).
- Allergy to curcumin or turmeric.
- Allergy to black pepper
- Markwalder Grading Scale Score: 3-4
- 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.
Key Trial Info
Start Date :
December 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03845322
Start Date
December 18 2018
End Date
February 26 2020
Last Update
May 25 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of New Mexico Health Sciences center
Albuquerque, New Mexico, United States, 87122