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Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia

Primary Purpose

Epistaxis, Hereditary Hemorrhagic Telangiectasia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sclerotherapy
Standard Treatment
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epistaxis focused on measuring Epistaxis, Hereditary Hemorrhagic Telangiectasia, HHT, Sclerotherapy, Epistaxis (nosebleeds) due to Hereditary Hemorrhagic Telangiectasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • previous sclerotherapy with Sodium Tetradecyl Sulfate

Sites / Locations

  • University of Minnesota Otolaryngology Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard Treatment then Sclerotherapy Intervention

Sclerotherapy Intervention then Standard Treatment'

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 1, 2011
Last Updated
October 30, 2019
Sponsor
University of Minnesota
Collaborators
American Rhinologic Society
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1. Study Identification

Unique Protocol Identification Number
NCT01408732
Brief Title
Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia
Official Title
Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
American Rhinologic Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Ninety percent of patients who suffer from Hereditary Hemorrhagic Telangiectasia (HHT) experience epistaxis which can range from mild to recurrent, severe, life threatening episodes. Current methods to treat significant epistaxis have limitations, namely the need for general anesthesia and repeated treatments. The objective of this study is to test a novel and tolerable office-based treatment method, sclerotherapy with sodium tetradecyl sulfate (STS), for recurrent epistaxis related to HHT. Sclerotherapy is the treatment of vascular lesions by injection with an agent which causes thickening of the vessel wall, obstruction of blood flow, clot formation and collapse of the lesion. Sclerotherapy is an established treatment modality for vascular malformations in the skin, GI tract, genitourinary tract and has been used for lesions in various sites in the head and neck. STS is an anion surfactant (detergent) that is commonly used for sclerotherapy. There are case reports in the literature describing sclerotherapy treatments for epistaxis related to HHT using other agents, but these case reports did not lead to prospective studies. We have performed a pilot study to analyze the tolerability and effectiveness of sclerotherapy with STS in a series of patients with recurrent epistaxis related to HHT. In our series, the treatment was found to be well tolerated and effective, based on patient administered questionnaire and review of clinical data. No complications related to the procedure were noted. Further prospective studies would help elucidate the role of sclerotherapy with STS in the treatment algorithm for recurrent epistaxis related to HHT. Our goal is to conduct a prospective, randomized-controlled trial to test the efficacy and tolerability of sclerotherapy using STS in the treatment of recurrent epistaxis due to HHT. A modified crossover design will be utilized with the intervention group receiving sclerotherapy, plus any additional, previously utilized standard treatment methods needed to control epistaxis. The control group will receive their current standard treatment methods, followed by delayed intervention with sclerotherapy. The primary outcomes will be frequency and severity of epistaxis. Secondary endpoints will be hemoglobin level, tolerability of treatment, additional treatment requirements, and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis, Hereditary Hemorrhagic Telangiectasia
Keywords
Epistaxis, Hereditary Hemorrhagic Telangiectasia, HHT, Sclerotherapy, Epistaxis (nosebleeds) due to Hereditary Hemorrhagic Telangiectasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Treatment then Sclerotherapy Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Sclerotherapy Intervention then Standard Treatment'
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sclerotherapy
Other Intervention Name(s)
Sotradecol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Treatment
Intervention Description
Normal standard of care followed by Drug interevention
Primary Outcome Measure Information:
Title
Severityof Epistaxis
Description
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
Time Frame
Change from Baseline to 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: previous sclerotherapy with Sodium Tetradecyl Sulfate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Boyer, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Otolaryngology Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia

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