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Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia

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ClinicalTrials.gov Identifier: NCT01408732
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : April 20, 2018
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
American Rhinologic Society
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epistaxis
Hereditary Hemorrhagic Telangiectasia
Interventions Drug: Sclerotherapy
Other: Standard Treatment
Enrollment 18
Recruitment Details  
Pre-assignment Details Each group will get the same therapy in a different order Total number of subjects 18 with 2 incompletes. First period is 6 weeks with a 2 week washout period and 2 period is 6 weeks
Arm/Group Title Sclerotherapy Intervention Then Standard Treatment Standard Treatment Then Sclerotherapy
Hide Arm/Group Description This group will receive, on the first period 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. Washout period of 2 weeks 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
Period Title: Overall Study
Started 9 9
Completed 7 7
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             2             2
Arm/Group Title Entire Study Population
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
51.8
(31 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
9
  50.0%
Male
9
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
Curacao criteria   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Visceral Lesions 9
Family history: 9
[1]
Measure Description:

1. Epistaxis;: spontaneous, recurrent nose bleeds 2. Telangiectases: multiple, at characteristic sites (lips, oral cavity, fingers, nose) 3. Visceral Lesions such as gastrointestinal telangiectasia (with or without bleeding), pulmonary arteriovenous malformation (AVM), hepatic AVM, cerebral AVMs, spinal AVM 4. Family history: a first degree relative with HHT according to these criteria

Diagnosis of HHT Define: 3 criteria are present Possible or suspected: 2 criteria are present Unlikely: <2 criteria are present

(Shovlin et al)

Number of Telangiectasia  
Mean (Full Range)
Unit of measure:  Telangiectasia
Number Analyzed 18 participants
7
(3 to 12)
Telangiectasia type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Type 1 4
Type 2 13
Type 3 1
[1]
Measure Description: (I) isolated punctate telangiectasias or individual small arteriovenous malformation; (II) diffuse interconnecting vasculature with "feeder" vessels; and (III) large solitary arteriovenous malformation, which may be associated with scattered telangiectasia (Mahoney and Shapshay)
Prior Treatment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Moisturization 11
Packing 4
Cautery 3
1.Primary Outcome
Title Severityof Epistaxis
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sclerotherapy Intervention Standard Treatment
Hide Arm/Group Description:

This group will receive, on the first period 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 period of the study this group will continue with standard treatments that they had been receiving for epistaxis prior to the study. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, and septodermoplasty.

Sodium tetradecyl sulfate (sotradecol): 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 standard treatment group will continue their pre-study "standard treatment" methods to treat epistaxis on the first period of the study, followed by intervention with sclerotherapy on the second period of the study, plus any additionally needed standard treatments for breakthrough epistaxis. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, septodermoplasty, and any other treatments that the patient reports using that are accepted as standard of care.

Sodium tetradecyl sulfate (STS) is injected into the nasal lesions as a solution prepared by foaming STS with air at a 4:1 ratio. 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. Multiple lesions can be treated bilaterally, each with a separate injection.

Standard Treatment

Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.4578  (2.8943) -1.4375  (4.1993)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sclerotherapy Intervention Standard Treatment
Hide Arm/Group Description

This group will receive, on the first period 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 period of the study this group will continue with standard treatments that they had been receiving for epistaxis prior to the study. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, and septodermoplasty.

Individual injection amounts vary between lesions, patients and treatment sessions. No more than 3 ml of solution is used in each session.

The standard treatment group will continue their pre-study "standard treatment" methods to treat epistaxis on the first period of the study, followed by intervention with sclerotherapy on the second period of the study, plus any additionally needed standard treatments for breakthrough epistaxis. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, septodermoplasty, and any other treatments that the patient reports using that are accepted as standard of care.

Sodium tetradecyl sulfate (STS) is injected into the nasal lesions as a solution prepared by foaming STS with air at a 4:1 ratio. 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. Multiple lesions can be treated bilaterally, each with a separate injection.

Standard Treatment

All-Cause Mortality
Sclerotherapy Intervention Standard Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sclerotherapy Intervention Standard Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sclerotherapy Intervention Standard Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Holly Boyer, MD
Organization: University of Minnesota
Phone: 612-725-2000
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01408732     History of Changes
Other Study ID Numbers: Sclerotherapy for Epistaxis
First Submitted: July 1, 2011
First Posted: August 3, 2011
Results First Submitted: December 16, 2015
Results First Posted: April 20, 2018
Last Update Posted: May 30, 2018