Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia

NCT01408732 | Completed Phase 1 Results DMC

• 1 other identifier: 1101M95232
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a novel and tolerable office-based treatment method, sclerotherapy with sodium tetradecyl sulfate, for recurrent epistaxis (nosebleeds) related to Hereditary Hemorrhagic Telangiectasia (HHT) disease.

Conditions

Epistaxis; Hereditary Hemorrhagic Telangiectasia

Keywords

Epistaxis; Hereditary Hemorrhagic Telangiectasia; HHT; Sclerotherapy; Epistaxis (nosebleeds) due to Hereditary Hemorrhagic Telangiectasia

Outcome Measures

Primary Outcomes (1)

• Severityof Epistaxis

  The primary outcome measure will be severity of epistaxis as measured by the Epistaxis Severity Score (ESS). The ESS, a recently developed online questionarrie that calculates the grading system for epistaxis severity. The higher the score the more severe the nose bleeds are Scale consists of several questions with a range of scale from 0-5 The average score is calculated for a final assessment

  Change from Baseline to 14 weeks

Study Arms (2)

Standard Treatment then Sclerotherapy Intervention

EXPERIMENTAL

The standard treatment group will continue their pre-study "standard treatment" methods to treat epistaxis on the first 6 weeks of the study, followed by intervention with sclerotherapy on the second 6 weeks of the study, plus any additionally needed standard treatments for breakthrough epistaxis. Wash out period 2 weeks

Drug: Sclerotherapy; Other: Standard Treatment

Sclerotherapy Intervention then Standard Treatment'

EXPERIMENTAL

This group will receive, on the first 6 weeks of the study, sclerotherapy with STS to any visible lesions in the nose at the outset, followed by any needed standard treatments for breakthrough epistaxis. On the second 6 weeks of the study this group will continue with standard treatments that they had been receiving for epistaxis prior to the study. Wash out period of two weeks

Drug: Sclerotherapy; Other: Standard Treatment

Interventions

Sclerotherapy DRUG

3% Sodium tetradecyl sulfate (STS) is mixed with air at a ratio of 4 parts air to 1 part STS for injection into the affected vessels in the nose. Topical anesthetic is applied to the nasal mucosa prior to injections. Once the mixture is ready for injection, the needle is placed into the vessel, in a submucosal fashion, penetrating 1-2 mm, and very small quantities of foam are injected The amount of foam injected into each lesion varies between 0.1 cc to 0.25 cc. Individual injection amounts vary between lesions, patients and treatment sessions. No more than a total of 3 ml of solution is used in each session. During each session, several lesions can be treated, but the total amount of STS used does not exceed 3 cc.

Also known as: Sotradecol

Sclerotherapy Intervention then Standard Treatment'; Standard Treatment then Sclerotherapy Intervention

Standard Treatment OTHER

Normal standard of care followed by Drug interevention

Sclerotherapy Intervention then Standard Treatment'; Standard Treatment then Sclerotherapy Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a clinical diagnosis of HHT based on the Curacoa Criteria
• age 18 and older
• cognitive ability and willingness to sign the study consent form and complete the study forms and questionnaires

You may not qualify if:

• previous sclerotherapy with Sodium Tetradecyl Sulfate

Sponsors & Collaborators

• University of Minnesota: lead
• American Rhinologic Society: collaborator

Study Sites (1)

University of Minnesota Otolaryngology Clinic

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Epistaxis; Telangiectasia, Hereditary Hemorrhagic

Interventions

Sclerotherapy; Sodium Tetradecyl Sulfate

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Fatty Alcohols; Alcohols; Organic Chemicals; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids

Results Point of Contact

• Title: Holly Boyer, MD
• Organization: University of Minnesota

boyer011@umn.edu

612-725-2000

Study Officials

• Holly Boyer, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: August 3, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 1, 2019
• Results First Posted: April 20, 2018

Record last verified: 2019-10

Locations

US (1)