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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03845322
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of New Mexico

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 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.


Condition or disease Intervention/treatment Phase
Hematoma, Subdural, Chronic Drug: Curcumin Pill Drug: Placebo pills Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an experimental study, each consented subject will be instructed that he/she will be randomized to either the placebo group or the curcumin group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double-blinded, randomized placebo-controlled pilot study. The patients, neurosurgeons, nurses and clinical coordinators will be blinded except for the research pharmacists who will keep a key linking a code # on a bottle handed to the clinical coordinator and the patient's medical record number (MRN #). The pill bottles handed to the clinical coordinator will be identical for placebo and CC.
Primary Purpose: Treatment
Official Title: Clinical Action of Curcumin/Turmeric in Chronic Subdural Hematoma Recurrence
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : September 28, 2020
Estimated Study Completion Date : September 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Curcumin pills group
24 Patient will receive Curcumin (CC) pills, within 24 hours post-operatively (as long as they are able to take oral medication). It will then be continued TID
Drug: Curcumin Pill
Curcumin (turmeric extract), over the counter supplement (1 capsule/three times a day). According to the Company, each capsule contains: 270 mg of pure curcuminoids (curcumin) and 3 mg of black pepper extract. Recommended serving size is 3 capsules per day in total, the patients will receive 810 mg of pure curcumin and 9 mg of black pepper extract (peperine/BioPerine) per day.

Placebo Comparator: Placebo group
24 Patient will receive Placebo pills, within 24 hours post-operatively (as long as they are able to take oral medication. It will then be continued TID.
Drug: Placebo pills
The placebo pill is a vegetarian cellulose capsule, with cellulose powder inside. The composition is cellulose and magnesium stearate.




Primary Outcome Measures :
  1. Measurements by CT of subdural hematoma volume change [ Time Frame: 6 months ]
    Change of the total hematoma cavity volume compared to post-subdural drain removal to volumes of less than 80 cc in post-surgical patients


Secondary Outcome Measures :
  1. Recurrence rate of cSDH with and without CC treatment [ Time Frame: 6 months ]
    Change re-accumulation rate of cSDH


Other Outcome Measures:
  1. Patient's neurological status [ Time Frame: 6 months ]
    Change rate of persistent or recurrent neurological symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845322


Contacts
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Contact: Devon A Lara, BS 505.925.4392 DLara13@salud.unm.edu
Contact: Laila M Mohammad, MD 505.272.6094 LMoham@salud.unm.edu

Locations
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United States, New Mexico
University of New Mexico Health Sciences center Recruiting
Albuquerque, New Mexico, United States, 87122
Contact: sharareh sazesh    505-797-1237      
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Howard Yonas, MD UNM
  Study Documents (Full-Text)

Documents provided by University of New Mexico:
Informed Consent Form  [PDF] August 29, 2018


Publications of Results:
Other Publications:

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Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT03845322     History of Changes
Other Study ID Numbers: 17-348
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of New Mexico:
curcumin
chronic
recurrence
hematoma
subdural
turmeric
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Recurrence
Hematoma
Disease Attributes
Pathologic Processes
Hemorrhage
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries
Curcumin
Turmeric extract
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors