Clinical trial NCT01408732: Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia
Official title: Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Epistaxis
Hereditary Hemorrhagic Telangiectasia
Keywords: Epistaxis
Hereditary Hemorrhagic Telangiectasia
HHT
Sclerotherapy
Epistaxis (nosebleeds) due to Hereditary Hemorrhagic Telangiectasia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: American Rhinologic Society
First posted: 2011-08-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Severityof Epistaxis
timeFrame: Change from Baseline to 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Otolaryngology Clinic
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Holly Boyer, MD
role: PRINCIPAL_INVESTIGATOR
References: