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

NCT03845322 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 17-348
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematoma, Subdural, Chronic

Keywords

curcumin; chronic; recurrence; hematoma; subdural; turmeric

Outcome Measures

Primary Outcomes (1)

• Measurements by CT of subdural hematoma volume change

  Change of the total hematoma cavity volume compared to post-subdural drain removal to volumes of less than 80 cc in post-surgical patients

  6 months

Secondary Outcomes (1)

• Recurrence rate of cSDH with and without CC treatment

  6 months

Other Outcomes (1)

• Patient's neurological status

  6 months

Study Arms (2)

Curcumin pills group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Curcumin Pill DRUG

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.

Curcumin pills group

Placebo pills DRUG

The placebo pill is a vegetarian cellulose capsule, with cellulose powder inside. The composition is cellulose and magnesium stearate.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Health Sciences center

Albuquerque, New Mexico, 87122, United States

Location

Related Publications (19)

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  PMID: 12359244 RESULT

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Bronchiolitis Obliterans Syndrome; Recurrence; Hematoma

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Hematoma, Subdural; 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; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage; Wounds and Injuries; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Howard Yonas, MD

  UNM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 19, 2019
• Study Start: December 18, 2018
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: May 25, 2022

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)