Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia

NCT ID: NCT01408732

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-09-30

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.

Conditions

Epistaxis; Hereditary Hemorrhagic Telangiectasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Sclerotherapy

Intervention Type: 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.

Standard Treatment

Intervention Type: OTHER

Normal standard of care followed by Drug interevention

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

Group Type: EXPERIMENTAL

Sclerotherapy

Intervention Type: 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.

Standard Treatment

Intervention Type: OTHER

Normal standard of care followed by Drug interevention

Interventions

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.

Intervention Type: DRUG

Standard Treatment

Normal standard of care followed by Drug interevention

Intervention Type: OTHER

Other Intervention Names

Sotradecol

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Rhinologic Society

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holly Boyer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Otolaryngology Clinic

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1101M95232

Identifier Type: -

Identifier Source: org_study_id