Intranasal Bevacizumab for HHT-Related Epistaxis
HHT, Hereditary Hemorrhagic Telangiectasia, Epistaxis
About this trial
This is an interventional treatment trial for HHT focused on measuring HHT, Hereditary Hemorrhagic Telangiectasia, epistaxis, nose bleeds, nasal bleeding, Avastin, bevacizumab
Eligibility Criteria
Inclusion Criteria:
- The patient carries a diagnosis of hereditary hemorrhagic telangiectasia (HHT)
- The patient is to undergo treatment with electrocautery in the operating room under endoscopic visualization
- The patient is able to give informed consent
- The patient is at least 18 years old
Exclusion Criteria:
- The patient has had prior treatment with systemic or nasal bevacizumab within the past year
- The patient has undergone electrocautery for epistaxis within the 6 months prior to study enrollment
- The patient is a minor
- The patient is pregnant
- The patient is incapable of understanding the consent process
- The patient has a history of HIV or another known cause of immunosuppression, or is actively taking immunosuppressive medications due to organ transplantation, rheumatoid disease, or other medical conditions.
Sites / Locations
- Stanford University Department of Otolaryngology- Head and Neck Surgery
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Bevacizumab
Saline Control
The Stanford Hospital Investigational Pharmacy will perform all randomization, drug storage and management, as well as mixing and packaging for double-blinded injection of bevacizumab or saline control. Patients will undergo standard-of-care bipolar electrocautery of nasal telangiectasias in the Stanford Surgery Center operating room. At the time of electrocautery, patients will receive intranasal injection of either study drug or saline control. The surgeon performing the injection will be blinded to whether injection is composed of bevacizumab or saline control. Bevacizumab will be mixed by the Stanford Hospital Pharmacy to a total dose of 100mg in 4mL, and 50mg (2mL) will be injected into each side of the nose. Injections will be performed according to the standardized four-point injection protocol (0.5mL/site) based on the vascular anatomy of the nose published in 2012 by Dheyauldeen et al.
The Stanford Hospital Investigational Pharmacy will perform all randomization, drug storage and management, as well as mixing and packaging for double-blinded injection of bevacizumab or saline control. Patients will undergo standard-of-care bipolar electrocautery of nasal telangiectasias in the Stanford Surgery Center operating room. At the time of electrocautery, patients will receive intranasal injection of either study drug or saline control. The surgeon performing the injection will be blinded to whether injection is composed of bevacizumab or saline control. The saline control placebo will be mixed by the Stanford Hospital Pharmacy to a total dose of 4mL in order to be identical in quantity and appearance to the mixed doses of bevacizumab, and 2mL will be injected into each side of the nose. Injections will be performed according to the standardized four-point injection protocol (0.5mL/site) based on the vascular anatomy of the nose published in 2012 by Dheyauldeen et al.