Clinical Trial: Topical Bevacizumab for the Management of Recurrent Epistaxis in Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Topical Bevacizumab for the Management of Recurrent Epistaxis in Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

Brief Summary: Terence M. Davidson, MD is conducting a research study to find out more about the topical application of Avastin (proper chemical name is bevacizumab) in the treatment of epistaxis (nose bleeding) in patients with Hereditary Hemorrhagic Telangiectasia (HHT).

Detailed Summary:

Plans are to recruit patients with HHT from the UCSD Nasal Dysfunction Clinic. The HHT world is connected through the HHT Foundation. The Foundation is interested in VEGF inhibitors. They have carefully watched our work at UCSD for a long time and our two papers on Avastin have been circulated around the world. Those who come for our evaluation and are deemed appropriate for Bevacizumab injection will be recruited for this study. Those agreeing to participate will sign a consent form.

The treatment, regardless of participation in the proposed research, is to bring the patients to the operating room where under general anesthesia the nose is suctioned clean of blood clot, crust and secretion. The mucosa is then injected with a local anesthetic with adrenaline to reduce discomfort and to reduce bleeding. The nasal mucosa is treated with a KTP laser in our standard fashion. A 100mg of Avastin delivered in 4cc is then diluted with 4cc of normal saline to a total volume of 8cc. The dilution is made not for any known difference in treatment but rather it normally takes a minimum of 8cc to properly inject the nasal mucosa. The 1% Bevacizumab is then injected submucosally throughout the nasal cavity sparing the mucosa of the cartilage and the septum. The nasal cavity is then sprayed with 2cc of a fibrin sealant (EVICEL) this reduces postoperative bleeding and facilitates healing from the laser therapy. It has nothing to do with the Bevacizumab injection. The patient is then awakened and returned to the recovery room and discharged home. Beginning in approximately one week the patient is instructed to begin their hypertonic pulsatile nasal irrigations. They will follow-up in the clinic at 1 month. The data collection form is attached. Prior to treatment patient completes the HHT epistaxis severity score, blood is drawn for hematocrit, hemoglobin and serum feritin levels. Women of
Sponsor: University of California, San Diego

Current Primary Outcome: Measurement of epistaxis in patients with HHT as measured by the HHT foundation Epistaxis Severity Score, hematocrit, hemoglobin and serum ferritin levels. [ Time Frame: 1-2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, San Diego

Dates:
Date Received: July 18, 2011
Date Started: June 2009
Date Completion: January 2014
Last Updated: July 18, 2011
Last Verified: July 2011