The purpose of this research is to test the use of Acetazolamide in preventing post-operative
cerebrospinal fluid leak in patients having endoscopic skull base surgery (it is a surgery
performed through the nose and sinus).
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02902133
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Elective transsphenoidal resection of a tumor expected to result in an intraoperative high flow CSF leak; such tumors include craniopharyngioma, meningioma, and Rathke cleft cyst.
Elective transsphenoidal resection of a pituitary adenoma, with BMI >25, or with observed low or high flow CSF leak during surgery, conferring an elevated risk of postoperative CSF leak.
Patients who voluntarily sign Informed Consent
Male subjects and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception during study treatment and for at least 1 month after stopping study treatment. Male subjects should refrain from donating semen during treatment and 1 month after stopping treatment.
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Patients with prior adverse reactions to acetazolamide or who are taking aspirin concomitantly (which may increase the risk of adverse reactions to acetazolamide)
Patients with moderate to severe chronic obstructive pulmonary disease (which may increase the risk of adverse effects of acetazolamide)
Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis.
It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy
Pregnant females, breastfeeding females, and males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception
All locations for NCT02902133
View full eligibility
Tris trial is registered with FDA with number: NCT02902133. The sponsor of the trial is University of Miami and it is looking for 0 volunteers for the current phase.
Official trial title: Pilot Study of Acetazolamide to Prevent Post Operative Cerebrospinal Fluid (CSF) Leak in Patients Undergoing Endoscopic Skull Base Surgery
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