Bevacizumab (Avastin) - Nose bleeding

Study Update

EXCLUSION CRITERIA MODIFIED - This change will allow the investigators to include more HHT patients in the study. "We had previously been finding many patients ineligible because of the frequency with which they require nasal treatments- but once this modification is approved by the Stanford IRB we should be able to now enroll these patients who previously did not qualify."

ONLY 8 more patients needed to conclude this study. Financial support is available to offset reasonable travel expenses to Palo Alto, CA for Bevacizumab (Avastin) clinical trial participants. Complete, save, and email the ELIGIBILITY FORM to [email protected] to be considered for this study.

Overview

Cure HHT, in partnership with the American Academy of Otolaryngology, is funding this important research as a follow-up to the Cure HHT North American Study of Epistaxis (NOSE Study) in which the efficacy of four agents (i.e., Bevacizumab, Estriol, Tranexamic Acid, and Saline) were tested in the first large-scale multi-center clinical trial.

The Stanford Sinus Center at the Stanford School of Medicine is poised to carry out the first randomized, double-blind, placebo-controlled clinical trial of bevacizumab injection versus saline control for the management of HHT-related epistaxis, by which they hope to shift the current clinical practice paradigms in treating this debilitating disease.

Study Aims

1. Determine if intranasal bevacizumab injection decreases nosebleed frequency and severity compared to placebo when used in conjunction with electrocautery for patients with HHT, as measured by the ESS scoring system.
2. Determine if intranasal bevacizumab injection results in a greater improvement in quality of life compared to placebo when used in conjunction with electrocautery for patients with HHT.
3. Determine the cost-effectiveness of intranasal bevacizumab injection compared to placebo when used in conjunction with electrocautery for patients with HHT.

Question

Does Avastin injection inside the nose at the time of nasal bipolar cautery reduce nasal bleeding?

Study Procedure

• Injection of Avastin or placebo inside the nose at the time of nasal electrocautery surgery (while patient is asleep)
• Patient completed surveys about nasal bleeding at 1 month, 2 months, 4 months, and 6 months after treatment

Who can participate

• Anyone 18 or older with HHT who would like to have electrocautery for their nasal bleeding AND
• Can complete surveys at the four time points after surgery

Who cannot participate

• Anyone receiving prior treatment with Avastin within the past 1 year
• Anyone who has had nasal electrocautery within the past 6 months
• Pregnant women
• Anyone with immune system disease
• Children under 18

What is required of me to participate

• Travel a minimum of one (1) trip to Stanford, CA - a visit in the clinic and surgery the next day*
• Have reliable contact information to complete the surveys
• Complete several surveys by mail after surgery at 1 month, 2 months, 4 months, and 6 months
• There is no monetary compensation for participation
• While the cost of the Avastin will be fully covered by the research funding, your insurance will be billed for any hospital-related costs of the surgery and you may be responsible for a co-pay.

What do I have to do to participate?

Complete, save, and email the ELIGIBILITY FORM to [email protected]

*Thanks to the generosity of one of our donors, Cure HHT is pleased to offer financial support to offset reasonable travel expenses to Palo Alto, CA for Bevacizumab (Avastin) clinical trial participants who have a documented financial need. Detailed information will be made available by the principal investigator when a participant is enrolled in the clinical trial.