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 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.

Condition or disease	Intervention/treatment	Phase
Epistaxis Hereditary Hemorrhagic Telangiectasia	Drug: Sclerotherapy Other: Standard Treatment	Phase 1 Phase 2

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	18 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia
Study Start Date :	February 2011
Actual Primary Completion Date :	September 2014
Actual Study Completion Date :	September 2014

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Hereditary hemorrhagic telangiectasia

Genetic and Rare Diseases Information Center resources: Hereditary Hemorrhagic Telangiectasia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Standard Treatment then Sclerotherapy Intervention 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 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. Other Name: Sotradecol Other: Standard Treatment Normal standard of care followed by Drug interevention
Experimental: Sclerotherapy Intervention then Standard Treatment' 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 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. Other Name: Sotradecol Other: Standard Treatment Normal standard of care followed by Drug interevention

Arm

Intervention/treatment

Experimental: Standard Treatment then Sclerotherapy Intervention

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

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.

Other Name: Sotradecol

Other: Standard Treatment

Normal standard of care followed by Drug interevention

Experimental: Sclerotherapy Intervention then Standard Treatment'

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 Name: Sotradecol

Other: Standard Treatment

Normal standard of care followed by Drug interevention

Outcome Measures

Primary Outcome Measures :

Severityof Epistaxis [ Time Frame: Change from Baseline to 14 weeks ]
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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408732

Locations


United States, Minnesota
University of Minnesota Otolaryngology Clinic
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

American Rhinologic Society

Investigators


Principal Investigator:	Holly Boyer, MD	University of Minnesota - Clinical and Translational Science Institute

More Information


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 Posted:	August 3, 2011 Key Record Dates
Results First Posted:	April 20, 2018
Last Update Posted:	May 30, 2018
Last Verified:	April 2018

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:


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

Additional relevant MeSH terms:


Telangiectasis Epistaxis Telangiectasia, Hereditary Hemorrhagic Vascular Diseases Cardiovascular Diseases Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases	Hemorrhage Pathologic Processes Hemostatic Disorders Hemorrhagic Disorders Hematologic Diseases Vascular Malformations Cardiovascular Abnormalities Congenital Abnormalities

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