The purpose of this study is to determine whether hydroxychloroquine decreases the relative
leakage of the brain barrier after surgery.
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT03025087
Ages eligible for Study
50 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Male or female, age ≥ 50 years old.
Patients scheduled to undergo cardiac surgery (CABG, CABG + Valve, Valve) with CPB or
general surgery (e.g. orthopedic, abdominal, urological).
Patient has voluntarily signed and dated the study-specific informed consent form
approved by Duke University Health System Institutional Review Board (DUHS IRB)
Cardiac surgery scheduled to be performed without cardiopulmonary bypass
Patients requiring emergent operation
Patients with a history of myocardial infarction within 7 days of surgery
Patients with a history of porphyria, psoriasis, chronic dermatitis, or retinal
Patients receiving preoperative digoxin
Patients with symptomatic cerebrovascular disease with substantial residual deficit
Patients with a history of alcohol abuse within 2 years of screening
Patients with history of psychiatric illness and/or anxiety requiring medical
Patients with impaired liver and/or kidney functions (AST, ALT 2 times the upper limit
Patients with impaired renal functions (GFR < 60ml/min)
Patients with less than a 7th grade education or unable to read and thus unable
complete the neuropsychological testing
Patients scoring < 26 on a baseline Mini Mental State examination (MMSE) or scoring
>27 on the Center for Epidemiological Studies - Depression (CES-D) scale
Female subjects of childbearing potential who have had menstrual period within the
past two years
Patients with bodily implants unsafe for MRI use
Patients with a history of claustrophobia
Known or suspected hypersensitivity to quinine (chloroquine or hydroxychloroquine)
Patient with pre-existing diagnosis of G6PD deficiency
Patients who have participated in another interventional clinical study within the
previous 30 days
Any other concurrent disease or illness that, in the opinion of the investigator,
makes the patient unsuitable for the study
Major ophthalmologic comorbidities (ex: ruptured globe, retinal vascular occlusive
disease, retinal artery occlusion, anterior ischemic optic neuropathy, media
opacification due to corneal abnormalities or cataract that prevent ocular and optical
coherence tomography examination, glaucoma, age-related macular degeneration, history
of intravitreal injections, and macular edema)
Patients who have received chemotherapy in the last 12 months
Patient with a QTc of 450 msec or greater (or 500 msec or greater in those with known
IVCD, RBBB, or LBBB) at baseline will be excluded.
All locations for NCT03025087
United States (1)
Durham, North Carolina, United States, 27710
Put me in touch!
View full eligibility
Tris trial is registered with FDA with number: NCT03025087. The sponsor of the trial is Duke University and it is looking for 30 volunteers for the current phase.
Official trial title: Hydroxychloroquine and Cognitive Function After Surgery
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