Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia - Full Text View

Purpose

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	Intervention
Epistaxis Hereditary Hemorrhagic Telangiectasia	Drug: Sodium tetradecyl sulfate (sotradecol)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia

Resource links provided by NLM:

Genetics Home Reference related topics: capillary malformation-arteriovenous malformation syndrome hereditary hemorrhagic telangiectasia Parkes Weber syndrome

Drug Information available for: Sodium Tetradecyl Sulfate Sulfate ion

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

Frequency of epistaxis [ Time Frame: Baseline (pre-treatment), at 6 weeks after baseline visit and at 12 weeks after baseline visit. ] [ Designated as safety issue: No ]
The primary outcome measure will be frequency and severity of epistaxis as measured by the Epistaxis Severity Score (ESS). The ESS, a recently developed grading system for epistaxis severity, has been recommended for comparison of existing and new therapies for epistaxis. The ESS was reported to be an accurate, reproducible, validated objective measure of epistaxis severity. The ESS will be measured at baseline in both treatment groups, and at the end of the first and second periods. Monthly diaries will be kept to aid in accuracy of reporting the ESS.
Severity of epistaxis [ Time Frame: Baseline (pre-treatment), at 6 weeks after baseline visit and at 12 weeks after baseline visit. ] [ Designated as safety issue: No ]
Severity of epistaxis will be measured by the Epistaxis Severity Score (ESS). The ESS, a recently developed grading system for epistaxis severity, has been recommended for comparison of existing and new therapies for epistaxis. The ESS was reported to be an accurate, reproducible, validated objective measure of epistaxis severity. The ESS will be measured at baseline in both treatment groups, and at the end of the first and second periods. Monthly diaries will be kept to aid in accuracy of reporting the ESS.

Secondary Outcome Measures:

Hemoglobin level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Blood exams will be performed to assess subject's hemoglobin level.
Tolerability of sclerotherapy [ Time Frame: Baseline (pre-treatment), at 6 weeks after baseline visit and at 12 weeks after baseline visit. ] [ Designated as safety issue: No ]
Tolerability of sclerotherapy will be measured through patient administered questionnaires after the sclerotherapy procedure.
Patient's need for additional treatment [ Time Frame: At 6 and 12 weeks follow-up visits and any additional visit, if needed, between this time frame ] [ Designated as safety issue: No ]
Patient's need for additional treatment besides sclerotherapy will be measured through patient request for extra treatment, and degree of blood loss during epistaxis.
Overall quality of life [ Time Frame: Baseline (pre-treatment), at 6 weeks after baseline visit and at 12 weeks after baseline visit. ] [ Designated as safety issue: No ]
Quality of life will be measured using the SF-12 instrument. This will be collected at the end of each 3 month interval.

Estimated Enrollment:	38
Study Start Date:	February 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sclerotherapy Intervention 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.	Drug: 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 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
Active Comparator: Standard Treatment 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.	Drug: 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 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

Arms

Assigned Interventions

Experimental: Sclerotherapy Intervention

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.

Drug: 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 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

Active Comparator: Standard Treatment

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.

Drug: 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 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408732

Contacts

Contact: Patricia Fernandes, DDS, MS

612-626-3018

ferna079@umn.edu

Locations

United States, Minnesota
University of Minnesota Otolaryngology Clinic	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Patricia Fernandes, DDS, MS 612-626-3018 ferna079@umn.edu
Principal Investigator: Holly Boyer, MD

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

No publications provided

Responsible Party:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT01408732 History of Changes
Other Study ID Numbers:	Sclerotherapy for Epistaxis
Study First Received:	July 1, 2011
Last Updated:	February 27, 2013
Health Authority:	United States: Food and Drug Administration

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:

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

Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities
Sodium Tetradecyl Sulfate
Sclerosing Solutions
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013